[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antimicrobial-drug-resistance\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antimicrobial-drug-resistance":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,93,122,152,175],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100626096","british-columbia-prescriber-feedback-program---antimicrobial-resistance-100626096",false,"NCT07431190","British Columbia Prescriber Feedback Program - Antimicrobial Resistance","Building a National Framework to Combat Antimicrobial Resistance in Primary Care (CANBuild-AMR): Study Protocol for an Impact Evaluation of the British Columbia Prescriber Feedback Program","Practitioner Inclusion Criteria:\n\nRegistered in 2024 with the BC Medical Services Plan (MSP) with:\n\n* A valid MSP billing number;\n* Status of Salaried, Private Practice, Temporary Licence, or Post Graduate;\n* Prescribed \\>100 dispensed medications in 2024.\n\nExclusion Criteria:\n\n* Previously opted out of the Therapeutics Initiative Portrait program\n\nPatient Exclusion Criteria:\n\n* Age \\\u003C18 years at time of oral antibiotic dispensation;\n* Received PharmaCare benefits through the Palliative Care program at any time during the baseline or study period;\n* Hospitalized within 1 week prior to an antibiotic prescription at any time during the baseline or study period;\n* On chronic suppressive antibiotic therapy (≥90 days' supply of any antibiotic dispensed) during the baseline or study period","ALL","18 Years",{"count":19,"type":20},7626,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this study is to evaluate an educational intervention that aims to reduce the number of unnecessary antibiotics prescribed by family physicians and nurse practitioners in British Columbia, Canada.\n\nThe intervention materials include a confidential personalized prescribing \"portrait\" and an evidence-based educational summary (therapeutics letter), accompanied by an introduction letter.\n\nThe main research questions are:\n\n1. Will the intervention lead to a reduction in the overall number of antibiotics prescriptions started?\n2. Will the intervention lead to a reduction in the proportion of antibiotics prescribed that are likely unnecessary, especially prescriptions for upper respiratory tract infections, acute bronchitis, acute sinusitis?\n\nResearchers will conduct an intervention study with family physicians and nurse practitioners in British Columbia, Canada. Participant clinicians will be randomly assigned to one of two groups. The Early Group will consist of 80% of the participants and will receive the intervention (prescribing portrait, evidence summary, and introduction letter) at the start of the study. The Delayed Group will consist of 20% of participants and will receive the intervention about nine months later. This study design allows most practitioners to receive the intervention early while still allowing time to compare the two groups to assess the impact. To estimate the impact of the intervention, researchers will use administrative health data to compare the prescribing of the Early Group with prescribing of the Delayed Group.",[26,27,28,29,30],"Quality Improvement","Feedback","Prescribing","Antibiotics","Antimicrobial Drug Resistance",[32,33,34,29,35],"Randomized controlled trial","Prescribing feedback","Quality improvement","Antimicrobial resistance","NOT_YET_RECRUITING","2026-02-17",{"date":39,"type":40},"2026-02-24","ACTUAL",{"date":37,"type":20},{"date":43,"type":20},"2028-11-30",{"name":45,"class":46},"University of British Columbia","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":70,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100611237","cocreating-action-to-improve-rationality-in-the-health-system-100611237","NCT07237971","Cocreating Action to Improve Rationality in the Health System","CAIR","Survey general population:\n\nA representative population survey of adult (aged 18 years and over) who are residents in the Municipal District 2 of Elche (Spain).\n\nSurvey community pharmacies:\n\nIndividuals who visit the pharmacies collaborating in the Municipal District 2 of Elche (Spain) to obtain any of the medications, aged 18 years and over for three a priori established medication groups.\n\n* Group 1 (Antidepressants and Anxiolytics): N05B, N05C, N06A.\n* Group 2 (Cardiovascular disease risk factor medication): A10B (antidiabetics), C10A (cholesterol-lowering drugs), C07A, C09A, C03C, C08C (antihypertensives).\n* Group 3 (Antibiotics): J01\n\nHealth service data from primary care:\n\nA series of aggregate indicators will be collected from the electronic information systems of the regional health authorities (Conselleria de Sanidad de la Generalitat Valenciana), which hosts information on both prescriptions made by physicians and those dispensed in the community pharmacies of the Valencian Community. These indicators will be calculated for individuals aged 18 years and over for groups 2 and 3, and 12 years and over for group 1 using aggregate data from health system's registries and, therefore, not considering 12 years old as minimum age limit of the eligible participants in the present study protocol registry. Furthermore, aggregate data about the number of consultations will be collected in the two primary care facilities in the study area for individuals aged 18 and over.\n\nQualitative methods and cocreation procedure:\n\nFocus groups, sociograms and in-depth interviews will include 6-8 participants and last approximately 90 minutes. Participation in the co-creation process will be open, voluntary, and will depend on the interest of individuals and entities in the area. Eligibility criteria:\n\n* People aged 18 and over who are residents or have a job or family connection in the Municipal District 2 of Elche (Spain) who are interested in participating, wish to be actively involved in the co-creation, planning, and implementation of community initiatives, and are available to attend the conferences, meetings, and workshops.\n* Representatives from community institutions and associations, including professionals from the Elche Public Health Center, primary care teams in the area, Elche Council staff, as well as professionals and volunteers from NGOs and other local organizations with experience in community work in the district.",true,{"count":57,"type":20},4000,[23],"Despite widespread recognition of social, economic, or environmental health determinants, health action remains heavily dominated by individual-level solutions (e.g., medication, patient counselling, vaccination). This study aims to stimulate changes in health system functioning by demonstrating how the cocreation of actions to address psychological well-being, cardiovascular health, and antimicrobial resistance from within the community can alleviate the burden on primary care services, reduce medicalisation and increase health equity.\n\nThe scientific approach uses mixed methods and incorporates theory from multiple disciplines. This study will appraise how the current system addresses psychological well-being, cardiovascular (CV) health, and rational use of antibiotics using a population survey, a survey of patients collecting their medication at community pharmacies, aggregate health service indicators on medication consumption and primary care consultations, and qualitative methods exploring stakeholders' perceptions.The investigators will undertake community-based participatory research to engage citizen scientists in the cocreation of community-led actions to promote psychological well-being, CV health, and prevent antimicrobial resistance. The design, implementation, and evaluation of the actions will apply an assets-based approach and apply theories and frameworks from implementation science in an iterative manner over 3 years. Finally, the impact of the cocreated actions will be analysed, considering effectiveness and broader contextual issues such as initiative adoption, implementation, and maintenance. The investigators will use a before-after comparison of survey indicators, an interrupted time-series analysis of health service data and qualitative analysis.\n\nThe goal is to demonstrate how the integration of community action with attention to the social determinants of health, can lead to a more rational approach to health care and ultimately improve health and health equity.",[61,62,63,64,65,66,67,30,68,69],"Health-Related Quality-of-Life","Social Capital","Health Literacy","Community Based Participatory Research","Antibiotic Prescription","Mental Health Literacy","Cardio Vascular Disease","Well-being","Health Equity",[71,72,73,74,75,76,77,78,79,80,81],"Community health","Cocreation action","Health system","Health literacy","Social capital","Community capital","Antibiotic drug use","Cardiovascular drug use","Psychotropic drug use","Health-related quality of life","Health equity","RECRUITING","2025-11-24",{"date":85,"type":40},"2025-12-02",{"date":87,"type":40},"2025-10-21",{"date":89,"type":20},"2029-04-01",{"name":91,"class":46},"Universidad Miguel Hernandez de Elche",2,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":55,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":47},"100595244","phase-1-a-phase-1-study-of-the-safety-and-tolerability-of-single-and-multiple-ascending-doses-of-bwc0977-in-healthy-volunteers-100595244","NCT07029932","A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers","A Randomized, Double-blind, Placebo-controlled, Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult Volunteers","Inclusion Criteria:\n\n1. Age: Healthy male or female 18 to 55 years of age, inclusive, at time of consent\n2. Body mass index (BMI): BMI ≥ 19.0 and ≤ 30.0 (kg\u002Fm2) and weight between 55.0 and 100.0 kg (inclusive)\n3. Health Status: Medically healthy without significant history of any chronic diseases or conditions (such as cardiovascular, renal, hepatic, neurological, hematological, gastrointestinal, endocrine, or musculoskeletal disorders). Volunteers must have no clinically significant abnormalities in medical history, as determined by the Investigator.\n4. Screening Tests:\n\n   1. No findings in Physical examination or vital signs (including temperature, heart rate, respiratory rate, and blood pressure) that the Investigator determines would interfere with interpretation of study results\n   2. Triplicate ECGs without clinically significant abnormalities, including a QTcF interval duration ≤450 msec (for males), and ≤470 msec (for females), obtained as an average from the triplicate screening ECGs after at least 5 minutes in a supine, quiet-rest position\n   3. For clinically significant abnormalities in the screening clinical laboratory tests, vital signs, and ECG assessments as determined by the Investigator, repeat testing could be performed at the Investigator's discretion\n5. Informed consent: Willing and able to provide written informed consent\n6. Compliance: Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of events.\n7. Physical Activity Restrictions: Willing to refrain from strenuous physical activity that could cause muscle aches or injury, including contact sports, at any time from 4 days prior to admission in the clinical research unit (CRU) until completion of the study.\n8. Venous Access: Have suitable venous access for drug administration and blood sampling\n9. Contraception Requirements (for those of reproductive potential): Contraception requirements will follow institutional policies.\n\n   Females:\n\n   Must agree to use two forms of effective contraception-male partner using a condom plus 1 other highly effective method of birth control (e.g., Hormonal methods of contraception including oral contraceptives {includes Combined estrogen-progestin oral contraceptives (COCs) and progestogen-only contraceptives associated with inhibition of ovulation}, a vaginal ring, injectable and implantable hormonal contraceptives, indwelling intrauterine device, history of bilateral tubal ligation, sole vasectomized (bilateral vasectomy) partner with documented azoospermia 90 days after procedure) from signing the consent form until 33 days after last study drug administration, or agree to complete sexual abstinence for the duration of the study from screening and for 33 days after last study drug administration. Females of child-bearing potential must also agree not to donate ova or oocytes (i.e., human eggs) during the study, and for 33 days after completion of the study. For female participants, hormonal contraceptives should begin at least 1 month prior to screening to ensure the contraceptive is in full effect.\n\n   To be considered of non-childbearing potential, a female must have either a hysterectomy, bilateral salpingo-oophorectomy (at least 3 months prior to screening), or menopause {last menstruation \\>12 months in the absence of other biological causes and follicle-stimulating hormone levels in menopausal range (\\>40mIU\u002FmL)}, provision of written documentation is not required for female sterilization and oral confirmation is adequate. Female participants in same sex relationships do not need to utilize contraception.\n\n   Males:\n\n   If sexually active with a female partner of childbearing potential, must agree to use male condom plus 1 other highly effective method of birth control in their partner (e.g., Hormonal methods of contraception including oral contraceptives {includes Combined estrogen-progestin oral contraceptives (COCs) and progestogen-only contraceptives associated with inhibition of ovulation}, a vaginal ring, injectable and implantable hormonal contraceptives, indwelling intrauterine device, history of bilateral tubal ligation) from signing the consent form until 93 days after last study drug administration, or agree to complete sexual abstinence for the duration of the study from screening and for 93 days after last study drug administration. Hormonal contraceptives should be in use by female partner for at least 1 month prior to screening to ensure contraceptive is in full effect.\n\n   To be considered surgically sterile, male participants must have had bilateral vasectomy at least 3 months before screening with appropriate documentation of the absence of sperm in the ejaculate 90 days after procedure. The use of condom by male partner will be required if bilateral vasectomy is the chosen highly effective method of birth control.\n\n   Male participants must also agree not to donate sperms during the study and for 93 days after the last dose of the study drug.\n\n   Male participants in same sex relationships or sexually active with female of non-childbearing potential (as defined above) do not need to utilize contraception. Male participants with potentially postmenopausal partners who are under the age of 55 years must use condoms unless their partner's postmenopausal status has been confirmed by FSH level\n\n   Exclusion Criteria:\n   * 1\\) Pregnancy and Lactation: Women who are pregnant and\u002For lactating. 2) Significant Medical History: History or presence of significant cardiovascular (including QT prolongation, clinically significant hypokalemia, or other proarrhythmic conditions), pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine (including glucose intolerance, diabetes mellitus), immunologic (including asthma or seasonal allergies \\[that require intermittent use of steroids or other medication\\]), musculoskeletal (including tendinopathy), dermatologic, or neurological disease (including seizure disorders, psychiatric disorders), including any acute illness or surgery within the past 3 months, as determined by the Investigator to be clinically relevant.\n\n     1. History of any kidney disease or current or chronic history of impaired renal function as indicated by a calculated creatinine clearance (Cockcroft-Gault formula) \\\u003C80 milliliter per minute (mL\u002Fmin).\n     2. Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert syndrome or asymptomatic gallstones) 3) Laboratory abnormalities\n\n     a) Clinically significant abnormal findings in serum chemistry, hematology, coagulation or urinalysis results obtained at screening or check-in (Day-1) b) Alanine aminotransferase (ALT) more than (\\>)1 upper limit of normal (ULN) at screening or check-in (Day-1) c) Aspartate aminotransferase (AST) \\> ULN at screening or check-in (Day-1)d) Bilirubin \\>ULN at screening or check-in (Day-1) e) Serum creatinine \\> ULN at screening or check-in (Day-1). The serum creatinine or any laboratory test may be repeated prior to confirming exclusion, at the PI's discretion.\n\n     4\\) Electrocardiographic abnormalities: Baseline QTcF of \\>450 msec (for males), and \\>470 msec (for females) at screening or check-in (Day-1) 5) Photosensitivity: History of photosensitivity to quinolones 6) Clostridium Difficile: History of known or suspected Clostridium difficile infection 7) Hospitalization History: Any condition that necessitated hospitalization within the 3 months prior to Day -1 or is likely to require so during the study 8) Antibiotic History: No systemic antibiotic use within 5 days before dosing. 9) Infection History: Positive test for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV antibodies), or human immunodeficiency virus antibody (antibodies to HIV-1, HIV-2) at screening.\n\n     10\\) Recent Medications: Exclude participants receiving all prescription and OTC medications (except hormonal contraception and Paracetamol) 14 days or 5 half-lives, whichever is longer, prior to IP dosing.Discussion between the PI and the Sponsor Medical Monitor is encouraged regarding prior use of any medications during the pre-dose period. Note: An exception is made for hormonal contraceptives, paracetamol (a maximum of 4 doses per day of 500 mg, and no more than 3 g per week) for the treatment of headache or any other pain as per the PI's judgement.\n\n     11\\) Hypersensitivity: DocumentedHistory of significant hypersensitivity reaction or anaphylaxis to any medication, as determined by the Medical Officer.\n\n     12\\) Tobacco and Nicotine Use: Smoker (including tobacco, e-cigarettes, or marijuana) or nicotine user within 1 month prior to dosing and have a positive test for cotinine at check in on Day -1 (may be repeated once, at the discretion of the Investigator or Medical officer, in the instance of a positive result).\n\n     13\\) Drug\u002FAlcohol Abuse: Positive urine drug\u002Falcohol breath testing at screening or check-in (Day -1), or history of substance abuse or alcohol abuse (defined as greater than 2 standard drinks on average each and every day, where one standard drink is defined as containing 10 g of alcohol and is equivalent to 1 can or stubby of mid-strength beer, 30 ml nip spirits, or 100 ml wine) within the previous 5 years (may be repeated once per timepoint, at the discretion of the Investigator or Medical officer, in the instance of a positive result).\n\n     14\\) Blood\u002FPlasma Donation: Donation of blood within 30 days or plasma within 7 days prior to randomization, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of study enrollment.\n\n     15\\) Previous Study Participation: Previous participation in this study, i.e., who has already completed earlier cohorts or previous participation in another study within 5 half-lives (if known) of the agent, or 30 days, whichever is longer, of Day 1.\n\n   Note: prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable. Those who were screen failures or not dosed in this study may will be considered for re-screening in subsequent cohorts.\n\n16\\) Food Restrictions: Consumption of red wine, Seville oranges, grapefruit, or grapefruit juice, pummelos, exotic citrus fruits, grapefruit hybrids, or fruit juices containing such products from 7 days prior to the first dose of study medication.(Note: Lemon and lime, including their juice or zest, are permitted as they are not known to significantly affect cytochrome P450 (CYP3A4) enzyme activity) 17) Sponsor Relationships: Employee or family member of an employee of the Sponsor, CRU, or clinical research organization at which the study will be conducted.\n\n18\\) Non-compliance: Unable to cooperate fully with the requirements of the study protocol, including the schedule of events, or likely to be non-compliant with any study requirements.\n\n19\\) Other Medical Conditions: Any other disease or condition that, in the opinion of the Investigator, would preclude the subject's participation in the study or place them at risk as a result of study participation.\n\nNote: Volunteers should refrain from consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening and prior to Day -1 to avoid false positive drug screen results. Examples of foods to avoid include: poppy seed bagels, muffins, pastries, salad dressings, or any baked goods or dishes that list poppy seeds as an ingredient.","55 Years",{"count":102,"type":20},48,[104],"PHASE1","The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers.",[107,30],"Infectious Diseases",[109,110,111,112],"safety","Tolerability","Pharmacokinetics","BWC0977","2025-11-19",{"date":83,"type":40},{"date":116,"type":40},"2025-10-10",{"date":118,"type":20},"2026-08-30",{"name":120,"class":121},"Bugworks Research Inc.","INDUSTRY",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":47},"100600245","comparison-of-three-interventions-for-antibiotic-resistant-bacteria-arb-decolonization-from-the-gastrointestinal-tract-100600245","NCT07094984","Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract","Multicenter, Randomized, Open-label, Three-arm Study on the Efficacy of Fecal Microbiota Transplantation vs Probiotic Therapy vs Eubiotic-gut-microbiota-boosting Diet in Order to Antibiotic-resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract of Patients Colonized With Clinically Most Significant ARBs. Looking for a Strategy to Overcome the WHO Alarm on the Antibiotic Resistance \"New Pandemic\" Threat. STOP-ARB Study","STOP-ARB3","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Documented intestinal colonization with antibiotic-resistant bacteria confirmed by at least two positive cultures (rectal swabs or, alternatively, stool cultures), with the last positive result obtained at least 28 days prior to the planned procedure;\n* Documented colonization by one or more of the following bacterial strains:\n\n  1. Carbapenem-resistant strains with confirmed resistance mechanisms, including MBL+ (NDM+, VIM+, or others), KPC+, OXA-48+, or phenotypic carbapenem resistance without identified genetic mechanism;\n  2. Multidrug-resistant Enterobacteriaceae resistant to beta-lactams and other antibiotics, especially ESBL-producing strains, including Escherichia, Enterobacter, Klebsiella spp., and\u002For P. aeruginosa, A. baumannii (commonly associated with the ESKAPE group);\n  3. Gram-positive bacteria such as Enterococcus faecalis, Enterococcus faecium, or other vancomycin-resistant enterococci (VRE), as well as Staphylococcus aureus strains resistant to methicillin (MRSA) and\u002For vancomycin;\n* Absolute neutrophil count (ANC) in peripheral blood \\>500\u002FμL within 3 days prior to FMT; In case of tandem or repeated FMTs and expected neutrophil decline, the ANC test should be repeated before each FMT if the interval exceeds 3 days.\n\nFor patients without expected neutropenia (\\\u003C500\u002FμL), the blood count remains valid for 28 days;\n\n* Estimated life expectancy of at least 12 months;\n* Ability to swallow large capsules (confirmed using a test capsule) or absence of contraindications to colonoscopy;\n* No history of anaphylactic shock due to food allergies and ability to tolerate probiotic supplementation;\n* Provision of written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Lack of consent to participate in the study or inability to establish logical contact and obtain consent from an authorized representative;\n* Absolute neutrophil count (ANC) \\\u003C 500 cells\u002FμL on the day of FMT (within 3 days prior) or predicted decline to this level within the next 2 days;\n* Diagnosed HIV infection with CD4 lymphocyte count \\\u003C 250 cells\u002FμL;\n* Active infection requiring antibiotic therapy on the day of FMT or planned antibiotic use during the first 7 days following FMT;\n* Symptoms or radiological\u002Fendoscopic evidence of gastrointestinal mucosal damage within 7 days prior to FMT (e.g., ulceration, perforation, gastrointestinal bleeding) posing a risk of serious adverse events;\n* Contraindications for FMT administration via upper or lower gastrointestinal tract routes (e.g., gastrointestinal perforation, anal atresia, lack of intestinal continuity, or other);\n* Inability to undergo preparatory therapy (oral antibiotics: colistin, vancomycin, gentamicin and\u002For bowel cleansing agents) prior to FMT;\n* Inability to swallow large capsules (confirmed with test capsules) or contraindications for colonoscopy;\n* Severe food allergy with history of anaphylactic shock or inability to tolerate probiotics;\n* Pregnancy or breastfeeding;\n* Severe medical conditions contraindicating study protocol adherence as determined by the treating physician (e.g., severe heart failure precluding bowel cleansing due to risk of fluid overload or dehydration);\n* Participation in another clinical trial and administration of an investigational drug or device within 3 months prior to randomization;\n* Reluctance or inability to comply with protocol requirements, including any physical, mental, or social condition that may impair the participant's ability to adhere to the protocol.",{"count":131,"type":20},360,[23],"The aim of this research experiment is to evaluate the effectiveness of fecal microbiota transplantation (FMT) preceded by antibiotic pre-treatment versus probiotic therapy and a standard-of-care equivalent diet designed to stimulate the growth of eubiotic gut microbiota (an active comparator enhancing the ethical value of the study and increasing the chances of spontaneous decolonization of antibiotic-resistant bacteria (ARB) in the absence of any active intervention recommended by Scientific Societies) in the decolonization of bacteria with the most clinically significant antibiotic resistance mechanisms from the gastrointestinal tract of colonized patients.\n\nThis study addresses the urgent need highlighted by the World Health Organization (WHO) for new strategies to combat antibiotic resistance, aiming to prevent its progression into a global pandemic that could undermine the achievements of modern civilization.\n\nStudy Hypotheses:\n\n* The decolonization rate of ARB bacteria in patients undergoing the intervention (FMT or probiotic therapy) is the same as in patients treated with standard-of-care (SoC) alone.\n* The decolonization rate of ARB bacteria in the intervention groups (FMT or probiotic therapy) is at least 20 percentage points higher than in patients treated with the standard approach (diet).\n\nThe findings from this study may contribute to developing innovative microbiota-based therapies for the decolonization of antibiotic-resistant bacteria and help reduce the global burden of antibiotic resistance.",[135,30],"Drug Resistance, Bacterial",[137,138,139,140,141,142],"Fecal Microbiota Transplantation","FMT","Antibiotic-resistant bacteria decolonization","Eradication procedure","probiotic therapy","eubiotic diet","2025-08-26",{"date":145,"type":40},"2025-09-03",{"date":147,"type":40},"2024-12-31",{"date":149,"type":20},"2027-04-30",{"name":151,"class":46},"Medical University of Warsaw",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":55,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100590465","a-complex-intervention-to-promote-appropriate-antibiotic-use-among-rural-residents-based-on-the-metaphor-embedded-integrated-behavioral-model-100590465","NCT06967766","A Complex Intervention to Promote Appropriate Antibiotic Use Among Rural Residents Based on the Metaphor-Embedded Integrated Behavioral Model","Inclusion Criteria:\n\n* Residents aged 18 years and over who have lived in the survey township for more than 6 months\n\nExclusion Criteria:\n\n* Residents with mental illness, severe mental health problems, and those unable to complete the questionnaire",{"count":159,"type":20},1500,[23],"The study aims to address the question of how to provide effective health education on health topics with high medical specialisation (e.g. bacterial drug resistance in this study), especially for rural or low-educated populations. In response to the high degree of correlation between irrational antimicrobial drug use behaviours, how to achieve the effectiveness of interventions on the complex health topic of rational use of antimicrobial drugs through synergistic interventions with multiple scenarios?\n\nIn this study, the investigators used an experimental-like research design to conduct a full-scenario intervention involving antimicrobial drug acquisition, use, and disposal in a township-based approach, so as to reduce the prevalence of irrational antimicrobial drug use behaviours among rural residents, and to significantly improve the governance of antimicrobial drug use in rural areas. After six months of intervention, the following specific objectives were achieved:\n\n1. The incidence of self-treatment and use of antimicrobial drugs in the intervention group decreased by 30% compared with the control group;\n2. Rational use of antimicrobial drugs and awareness of bacterial drug resistance among rural residents in the intervention group increased by 50% compared with the control group;\n3. In the intervention group, the incidence of rural residents actively asking for antimicrobial drugs when seeking medical treatment, actively purchasing antimicrobial drugs without prescription at community pharmacies, stocking up on antimicrobial drugs at home, and improperly disposing of antimicrobial drugs decreased by 40%, 30%, 30%, and 50%, respectively, compared with that of the control group.\n\nThe study included the development and testing of metaphorical health materials and a multi-contextual metaphorical health education intervention. The implementation of the intervention included training in metaphorical health education and doctor-patient communication, a multi-situational intervention based on the theory of metaphorically embedded integrative behaviours, and the design of incentives for standardised antimicrobial drug discarding.",[30],[164,165],"health education","Metaphor","2025-05-07",{"date":168,"type":40},"2025-05-13",{"date":170,"type":20},"2025-05",{"date":172,"type":20},"2026-06",{"name":174,"class":46},"Bo Yan",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":55,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":200,"locationsCount":92},"100535955","dynamics-of-colonization-and-infection-by-multidrug-resistant-pathogens-in-immunocompromised-and-critically-ill-patients-100535955","NCT06258551","Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients","DYNAMITE","Inclusion Criteria:\n\n* Admission to an intensive care unit or stem cell transplant unit (for allogeneic stem cell transplantation) within previous 24 hours\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* Pregnancy\n* History of inflammatory bowel disease (Crohn's disease, ulcerative colitis)\n* Gastrointestinal derivation (colostomy, ileostomy, etc.)",{"count":183,"type":20},1000,"OBSERVATIONAL","The goal of this observational study is to investigate how bacterial populations from the intestine and mouth of patients change during the hospitalization period and evaluate if some populations of specific bacteria increase or decrease the risk of acquiring an infection or becoming colonized by pathogenic bacteria. Participants will have the following samples collected during enrollment: stool samples (maximum 2x\u002Fweek), blood draws (1x\u002Fweek), oral swab (1x\u002Fweek).",[30,187,188,189,190,191,192,193],"Antibiotic Resistant Infection","Clostridium Difficile","Carbapenem-Resistant Enterobacteriaceae Infection","Extended Spectrum Beta-Lactamase Producing Bacteria Infection","Vancomycin Resistant Enterococci Infection","Carbapenem Resistant Bacterial Infection","Vancomycin-Resistant Enterococcal Infection","2024-02-06",{"date":196,"type":40},"2024-02-14",{"date":198,"type":40},"2020-12-08",{"date":172,"type":20},{"name":201,"class":46},"The Methodist Hospital Research Institute"]