[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bacterial-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bacterial-infection":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,88],{"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":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100570613","phase-4-optimization-of-beta-lactam-dosing-in-critically-ill-patients-with-cystatin-c-optimize-gni-100570613",false,"NCT06709521","Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI)","Optimization of Beta-lactam Dosing in Critically Ill Patients With Suspected or Documented Antimicrobial Resistant Gram-Negative Infections With Cystatin-C (OPTIMIZE-GNI)","Inclusion Criteria:\n\n1. Age \\>\u002F=18 years at the time of enrollment.\n2. Residing in an ICU.\n3. Documented or suspected Antimicrobial Resistant (AMR) Gram-negative infection for which the prospective participant is receiving meropenem or cefepime as part of their clinical management.\n4. Expectation that the prospective participant will reside in the ICU and receive meropenem or cefepime for the duration of the study, and that all study procedures will be completed.\n5. Expectation that IV access will be sufficient for drug infusion and either IV or arterial access will be sufficient to allow for all protocol-required blood sampling to occur.\n6. The prospective participant, or their legally authorized representative (LAR), is able and willing to provide signed informed consent\n\nExclusion Criteria:\n\n1. Prospective participant has a documented hypersensitivity or allergic reaction to iohexol, any contrast agents, or iodine.\n2. Prospective participant has a documented prior history of severe cutaneous reactions to iohexol, any contrast agents, or iodine.\n3. Prospective participant received iohexol on the calendar day of enrollment or the expectation that they will receive iohexol for clinical care (i.e., Standard of Care \\[SOC\\]) during the study.\n4. Prospective participant had a major surgery within one calendar day prior to enrollment.\n5. Prospective participant had a recent (within 6 months) burn involving \\> 25% of total body surface area.\n6. Prospective participant had a penetrating injury within one calendar day prior to enrollment.\n7. Prospective participant is currently receiving or is expected to receive any type of renal replacement therapy including hemodialysis or extra corporeal membrane oxygenation, during study period.\n8. Prospective participant has a documented diagnosis of diabetes with a serum creatinine (SCR) obtained for clinical care purposes (i.e., SOC results) \\>3 mg\u002FdL during screening.\n9. Prospective participant has documented severe thyrotoxicosis as noted in medical records during screening.\n10. Prospective participant is homozygous for sickle cell disease as noted in medical history\u002Frecords.\n11. Prospective participant has a documented diagnosis of hepatorenal syndrome as noted in medical records during screening.\n12. Prospective participant is anuric\\* for \\>\u002F = 1 calendar day during screening AND has any one of the following documented conditions as noted in medical history\u002Frecords:\n\n    * Pheochromocytoma\n    * Myelomatosis\n    * Multiple myeloma\n    * Paraproteinemia \\*Anuria is defined as urine production \\\u003C100 mL in a calendar day\n13. Prospective participant is pregnant or breastfeeding.\n14. Prospective participant received or is expected to receive albumin from one calendar day prior to enrollment to end of study period.\n15. Prospective participant received or is expected to receive \\>\u002F= 3 units of any blood product other than platelets from one calendar day prior to enrollment to end of study period.\n16. Any condition that, in the judgment of the investigator, precludes participation because it could affect the prospective participant's safety.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This is a Phase 4, interventional, multi-center pharmacokinetics (PK) study in up to 200 adult patients who are residing in an ICU. This study will compare the abilities of Cystatin C (CysC) and CysC-based estimated Glomerular Filtration Rate (eGFR) equations to characterize the PK profiles of meropenem and cefepime relative to Serum Creatinine (SCR), Serum Creatinine based Equation (SCRE), and iohexol in critically ill patients with suspected or documented AMR Gram-negative infections. We hypothesize that CysC and CysC-based eGFR equations will characterize the PK profiles of meropenem and cefepime at the population and individual levels with greater accuracy and precision than SCR and SCREs. Iohexol will be administered to patients enrolled in the study and serve as the reference indicator of measured Glomerular Filtration Rate (mGFR), which is the gold standard assessment of kidney function. We further hypothesize that the predictive performances of CysC and CysC-based eGFR equations in estimating the PK profiles of meropenem and cefepime at the population and individual levels will be comparable to iohexol. Firstly, population PK (PopPK) modeling will be used to develop meropenem and cefepime PopPK models informed by CysC, CysC-based eGFR equations, SCR, and SCREs (renal function biomarkers), and iohexol clearance. Secondly, model diagnostics will then be used to compare the predictive performances of the renal function biomarkers PopPK models for each antibiotic relative to iohexol PopPK model. Lastly, Monte Carlo simulation (MCS) will be used to design PK\u002F pharmacodynamics (PD) optimized meropenem and cefepime dosing schemes based on the renal function biomarker PopPK model with the best predictive performance for use in the treatment of critically ill adult patients with suspected or documented AMR Gram-negative infections and varying degrees of renal function. The primary objective of this study is to compare the abilities of renal function biomarkers (CysC, CysC-based eGFR equations, SCR, SCREs) relative to iohexol to characterize the PK profiles of meropenem and cefepime in critically ill adult patients with suspected or documented AMR Gram-negative infections.",[26],"Bacterial Infection",[28,29,30,31,32,33,34,35],"AMR","Beta-lactam","Cefepime","cystatin-C","eGFR","Gram-negative","Iohexol","Meropenem","RECRUITING","2026-06-25",{"date":39,"type":40},"2026-06-26","ACTUAL",{"date":42,"type":40},"2025-02-12",{"date":44,"type":20},"2026-10-30",{"name":46,"class":47},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",10,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100641683","impact-of-culture-of-perfusion-fluid-on-donor-derived-infection-management-and-outcome-in-liver-and-kidney-transplant-100641683","NCT07651137","Impact of Culture of Perfusion Fluid on Donor-derived Infection Management and Outcome in Liver and Kidney Transplant","PREVENT","Inclusion Criteria:\n\n* Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods\n* Availability of graft preservation fluid culture results\n* Signed informed consent\n\nExclusion Criteria:\n\n* None",{"count":57,"type":20},1400,"OBSERVATIONAL","This study aims to evaluate whether microbiological testing of the perfusion fluid used to transport transplanted organs can help predict the development of infections in liver and kidney transplant recipients, including possible donor-derived infections (infections transmitted from the donor organ).\n\nThe study will include all liver and kidney transplant recipients with available perfusion fluid culture results from 2021 until the start of the study (retrospective phase) and for two years after study initiation (prospective phase).\n\nThe study will assess how often high-risk microorganisms are identified in perfusion fluid, whether these findings are associated with complications or infections in recipients, and whether they affect patient outcomes, including mortality.",[61,62,63,64,26,65],"Liver Transplant Infection","Kidney Transplant Infection","Liver Transplant","Kidney Transplant","Donor-derived Infection",[67,68,69,70,71,72,73,74,75],"perfusion fluid","graft","transplantation","transplant recipients","infections","donor-derived infections","liver transplant","kidney transplant","preservation fluid","NOT_YET_RECRUITING","2026-06-11",{"date":79,"type":40},"2026-06-16",{"date":81,"type":20},"2026-09-01",{"date":83,"type":20},"2029-08-31",{"name":85,"class":86},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100614914","phase-4-rifaximin-200-mg-plus-oral-rehydration-vs-oral-rehydration-alone-in-children-with-acute-diarrhea-100614914","NCT07285785","Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea","A Randomized, Open-Label Study to Assess Pharmacokinetics of Xifaxan® 200 mg in Pediatric Subjects 6 to 11 Years of Age With Acute Diarrhea of Suspected Bacterial Etiology, and the Safety and Efficacy of Xifaxan® 200 mg Plus Oral Rehydration Therapy (ORT) Compared to ORT Alone","Inclusion Criteria:\n\n1. Consent and assent are appropriately obtained prior to any study related activities, including discontinuation of any prohibited medications (subjects must sign an assent for the study and a parent or a legal guardian must sign the informed consent).\n2. Subject is between 6 to 11 (and 11 months) years of age, inclusive, and weighs at least 15 kg (33 lbs) at Screening.\n3. Females of childbearing (reproductive) potential must have a negative urine and serum pregnancy test at Screening and agree to use a highly effective method of contraception throughout their participation in the study. Acceptable methods of contraception are those alone or in combination, that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly and include hormonal methods (oral, injected or implanted), intrauterine device or intrauterine system or double barrier methods (simultaneous use of a physical barrier method by the subject and male partner, including a male condom and an occlusive cap \\[diaphragm or cervical\u002Fvault cap\\] with spermicidal). Abstinence or partner(s) with a vasectomy may be considered an acceptable method of contraception at the discretion of the Investigator.\n\n   NOTE: Female subjects are considered of child-bearing potential if they are (a) physiologically capable of becoming pregnant, defined as a female who has experienced menarche and (b) they will be, or could possibly be, engaging in sexual activity during the course of the study.\n4. Subject has diarrhea of suspected bacterial etiology defined by:\n\n   * At least 3 unformed stools in the last 24 hours prior to Screening.\n   * A fever ≥ 100.4°F (38°C) and ≤ 102.2°F (39°C) or has had a fever of ≥ 100.4°F (38°C) and ≤ 102.2°F (39°C) at any time since the development of abdominal pain or diarrhea.\n   * Illness for less than 96 hours at Screening.\n5. Parent or legal guardian and subject, when applicable based on aged, are capable of understanding the requirements of the study and willing to comply with all study procedures and visits.\n\nExclusion Criteria:\n\n1. Subject has a history of chronic diarrhea.\n2. Subject is unable to eat or drink.\n3. Subject has at least one of the following signs or symptoms:\n\n   * Presence of fever \\>39°C (\\>102.2°F).\n   * Presence of frank blood in stool.\n4. Subject has taken \\>2 doses of anti-diarrheal therapies in the 24 hours prior to randomization.\n5. Subject has taken any oral antimicrobial drug within 14 days of randomization.\n6. Subject has an unstable medical condition, in the opinion of the Investigator, (including, but not limited to, evidence of severe dehydration noted by tachycardia, abnormal blood pressure, or decreased skin turgor) at the Screening visit.\n7. Subject has known, clinically significant hepatic disease manifested by twice the age and sex-adjusted upper limit of normal (2 × ULN) for any of the following liver function tests: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, or total bilirubin (except in isolated elevation of unconjugated bilirubin).\n8. Subject has known, clinically significant renal disease (eg, 1.5 × ULN of serum creatinine or 2 × ULN of blood urea nitrogen levels).\n9. Subject has serum sodium of ≥150 mEq\u002FL and serum potassium ≤3.0 mEq\u002FL.\n10. Subject has a known hypersensitivity or allergy to Xifaxan®, rifampin, rifamycin-derived antibiotics, or any of the components of the rifaximin (Xifaxan®) formulations used in this study.\n11. Subject is pregnant or lactating or plans to become pregnant during the study.\n12. Subject has had a previous history of malignancy.\n13. Subject has a history of tuberculosis infection and\u002For has received treatment for tuberculosis infection.\n14. Subject has any concurrent illness, disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the Investigator.\n15. Subject has had significant blood loss within the 30 days prior to the Screening visit which prevents the collection of the blood volume required for this study.\n16. Subject has participated in an investigational drug or device study within the 30 days prior to randomization.\n17. Subject's parent or legal guardian, or an immediate family member is an employee of the site that is directly involved in the management, administration, or support of this study.\n18. Subject and\u002For legal guardian is unwilling or unable to comply with the study protocol for any other reason.\n19. Subject has a serum glucose level at screening that deviates from the reference range established by the central laboratory.\n20. Subject is taking a concomitant medication that is a P-glycoprotein (P-gp) inhibitor.\n21. Subject is taking warfarin for a pre-existing condition.","6 Years","12 Years",{"count":98,"type":20},54,[23],"The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria. It will also learn about the safety and effectiveness of rifaximin when given with oral rehydration therapy (ORT) compared with ORT alone. The main questions it aims to answer are:\n\nHow does rifaximin 200 mg move through and leave the body in children with acute diarrhea?\n\nIs rifaximin safe for children in this age group?\n\nDoes rifaximin plus ORT help resolve diarrhea faster than ORT alone?\n\nResearchers will compare rifaximin plus ORT to ORT alone to see if adding rifaximin improves outcomes.\n\nParticipants will:\n\nTake one rifaximin 200 mg tablet + ORT three times a day for 3 days or receive ORT alone\n\nReceive oral rehydration therapy according to the investigator's standard of care\n\nAttend up to 4 clinic visits over 5 days and receive 4 follow-up phone calls\n\nProvide blood samples on Day 1 and Day 3 for pharmacokinetic testing (rifaximin group only)\n\nProvide stool samples to identify bacterial pathogens\n\nKeep a diary of stool frequency and consistency to help determine when diarrhea resolves\n\nBe monitored for side effects, vital signs, and laboratory changes",[102,103,26],"Diarrhea","Gastroenteritis",[105,106,107,108,109,110,111,112,113,114,115],"pediatric","children","rifaximin","xifaxan","Oral Rehydration Therapy (ORT)","acute diarrhea","bacterial diarrhea","gastroenteritis","open-label","randomized","ages 6-11","2026-03-17",{"date":118,"type":40},"2026-03-18",{"date":120,"type":40},"2026-02-11",{"date":122,"type":20},"2027-07-31",{"name":124,"class":125},"Bausch Health Americas, Inc.","INDUSTRY",5]