[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chris Goss\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100616985","study-to-enable-new-diagnostics-for-pulmonary-microbes-in-people-with-cf-100616985",false,"NCT07312734","Study to Enable New Diagnostics for Pulmonary Microbes in People With CF","Study to Enable New Diagnostics for Pulmonary Microbes in People With CF (SEND-CF)","SEND-CF","Inclusion Criteria:\n\n* ≥ 16 years of age on day of study visit\n* Documentation of CF Diagnosis\n* Able to expectorate sputum\n* Percent predicted FEV1 ≥ 30%\n\nExclusion Criteria:\n\n* History of solid organ transplantation\n* History of active malignancy (or treatment for malignancy) in 12 months prior to the study visit\n* Pregnant","ALL","16 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","Sputum culture has been the best approach to detect harmful bacteria in the lungs of people with cystic fibrosis (CF). With the widespread use of new CF therapies (like Trikafta and Alyftrak), it is more difficult for people with CF to produce sputum even though they still have harmful bacteria in their lungs. The SEND-CF study is being done to see if there are other ways to detect harmful bacteria in the lungs.",[25,26],"Cystic Fibrosis (CF)","New Diagnostics",[28,29,30,31,32,33],"Cystic Fibrosis","CF","Breath collection","Specimen collection","Detection of pathogens","New diagnostics","RECRUITING","2026-07-01",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2026-03-30",{"date":42,"type":21},"2027-08-01",{"name":44,"class":45},"Chris Goss","OTHER",9,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100385079","phase-1-iv-gallium-study-for-patients-with-cystic-fibrosis-who-have-ntm-abate-study-100385079","NCT04294043","IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)","A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study)","ABATE","Inclusion Criteria for Treatment-Naïve NTM Cohort\n\n1. Written informed consent obtained from participant or participant's legal representative\n2. Be willing and able to adhere to the study visit schedule and other protocol requirements\n3. All genders ≥ 18 years of age at Visit 1\n4. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype\n5. Documentation of persistently positive NTM culture results that are positive for the same species or sub-species (either M. avium complex, M. abscessus complex, or both M. avium and M. abscessus). Persistently positive cultures are those which meet ONE of the following criteria, after first ignoring any negative culture results that occur within 7 days of a positive culture:\n\n   1. The two most recent NTM culture results from sputum or BAL taken at least 28 days apart are positive.\n\n      OR\n   2. At least one NTM culture result in the previous 4 months from sputum or BAL is positive. If there are four or more cultures in the last 12-months at least 3 out of the 4 most recent cultures must be positive for NTM. If there are three or fewer cultures in the past 12 months, then at least 2 of the 3 most recent cultures must be positive for NTM even if some of those cultures are more than 12 months ago.\n6. Current NTM species or subspecies has never been treated or previous treatment was associated with clearance of NTM and completed \\> 2 years prior to Day 1\n7. FEV1 ≥ 25 % of predicted value at Screening\n8. Able to expectorate sputum\n9. Clinically stable with no significant changes in health status within 7 days prior to Day 1\n10. Enrolled in the CFF Patient Registry (CFF PR)\n11. Willing to discontinue chronic azithromycin use for the duration of the study\n\nInclusion Criteria for Treatment-Refractory NTM Cohort\n\n1. Written informed consent obtained from participant or participant's legal representative\n2. Be willing and able to adhere to the study visit schedule and other protocol requirements\n3. All genders ≥ 18 years of age at Visit 1\n4. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype\n5. History of current or prior treatment for NTM pulmonary disease with M. abscessus or M avium (or both M. avium and M. abscessus)\n\n   1. Previously received treatment with guideline-based antibiotics for \\>12 months without having treatment discontinued for reasons of culture clearance OR\n   2. Currently receiving treatment with guideline-based antibiotics for \\>12 months\n6. FEV1 ≥ 25 % of predicted value at Screening\n7. Able to expectorate sputum\n8. Not hospitalized within 7 days prior to Day 1\n9. Enrolled in the CFF Patient Registry (CFF PR)\n10. Be willing and able to continue guideline-based antibiotic therapy for M. abscessus or M avium (or both M. avium and M. abscessus) concurrent with IV gallium, if currently on treatment\n\nExclusion Criteria Treatment-Naïve NTM Cohort\n\n1. Any of the following abnormal lab values at screening:\n\n   * Hemoglobin \\\u003C10g\u002FdL\n   * Platelets \\\u003C100,000\u002Fmm3\n   * Absolute neutrophil count \\\u003C 1500\u002Fmm3\n   * Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), or total bilirubin ≥3 x upper limit of normal\n   * Serum creatinine \\> 2.0 mg\u002Fdl and ≥1.5 x upper limit of normal\n   * Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal)\n2. History of solid organ or hematological transplantation\n3. Use of bisphosphonates within 7 days prior to Day 1\n4. Known sensitivity to gallium\n5. Use of any investigational drug and\u002For participated in any interventional clinical trial within 28 days prior to Day 1\n6. In the opinion of the Investigator, features of active NTM disease are present (e.g., clinical worsening is likely due to NTM disease despite definitive treatment of co-pathogens and\u002For acute exacerbations)\n7. Undergoing treatment for NTM disease or anticipate beginning treatment within 3 months\n8. Current diagnosis of osteoporosis\n9. For people of childbearing potential:\n\n   * Positive pregnancy test at Visit 1 or\n   * Lactating or\n   * Unwilling to practice a medically acceptable form of contraception (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal during the study\n10. For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study\n11. Has any other condition that, in the opinion of the Site Investigator\u002Fdesignee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives\n12. New initiation of chronic CF therapy (e.g., CFTR modulators, ibuprofen, azithromycin, inhaled tobramycin, Cayston, etc.) within 28 days prior to Visit 1 (Day 1)\n13. Use of azithromycin within 14 days prior to the screening visit\n\nExclusion Criteria Treatment-Refractory NTM Cohort\n\n1. Any of the following abnormal lab values at screening:\n\n   * Hemoglobin \\\u003C10g\u002FdL\n   * Platelets \\\u003C100,000\u002Fmm3\n   * Absolute neutrophil count \\\u003C 1500\u002Fmm3\n   * Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), or total bilirubin ≥3 x upper limit of normal\n   * Serum creatinine \\> 2.0 mg\u002FdL and ≥1.5 x upper limit of normal\n   * Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal)\n2. History of solid organ or hematological transplantation\n3. Use of bisphosphonates within 7 days prior to Day 1\n4. Known sensitivity to gallium\n5. Use of any investigational drug and\u002For participated in any interventional clinical trial within 28 days prior to Day 1\n6. Current diagnosis of osteoporosis\n7. For people of childbearing potential:\n\n   * Positive pregnancy test at Visit 1 (Day 1) or\n   * Lactating or\n   * Unwilling to practice a medically acceptable form of contraception (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal during the study\n8. For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study\n9. Has any other condition that, in the opinion of the Site Investigator\u002Fdesignee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives\n10. New initiation of chronic CF therapy (e.g., CFTR modulators, ibuprofen, inhaled tobramycin, Cayston, etc.) within 28 days prior to Visit 1 (Day 1)","18 Years",{"count":57,"type":21},40,"INTERVENTIONAL",[60],"PHASE1","The purpose of this study is to assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM.\n\nFunding Source - FDA Office of Orphan Products Development (OOPD)",[63],"Nontuberculous Mycobacterium Infection",[28,65,66,67,68,69,70],"Gallium Nitrate","IV Gallium","Nontuberculous mycobacterium","NTM","Mycobacterium abscessus","mycobacterium avium","2025-09-26",{"date":73,"type":38},"2025-10-01",{"date":75,"type":38},"2021-06-17",{"date":77,"type":21},"2027-03-31",{"name":44,"class":45},10,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":58,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100481383","phase-4-standardizing-treatments-for-pulmonary-exacerbations---aminoglycoside-study-100481383","NCT05548283","Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study","Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)","STOP360AG","Inclusion Criteria:\n\n* All genders ≥ 6 years of age at Visit 1\n* Documentation of a CF diagnosis\n* Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials\n* At least one documented Pa positive culture within two years prior to Visit 1\n\nExclusion Criteria:\n\n* Participant is not pregnant\n* No known renal impairment or history of solid organ transplantation\n* No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1\n* No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1\n* No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides\n* No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1","6 Years",{"count":90,"type":21},730,[92],"PHASE4","The purpose of this study is to look at pulmonary exacerbations in people with cystic fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention. Both doctors and CF patients are trying to understand the best way to treat pulmonary exacerbations. This study is trying to answer the following questions about treating a pulmonary exacerbation:\n\n* Do participants have the same improvement in lung function and symptoms if they are treated with one type of antibiotic (called beta-lactams or β-lactams) versus taking two different types of antibiotics (tobramycin and β-lactams)?\n* Is taking one type of antibiotic just as good as taking two types?",[28,95],"Cystic Fibrosis Pulmonary Exacerbation",[28,29,95,97,98,99,100,101],"aminoglycoside","beta-lactam","β-lactam","STOP","STOP360","2024-08-23",{"date":104,"type":38},"2024-08-26",{"date":106,"type":38},"2023-04-23",{"date":108,"type":21},"2026-11-15",{"name":44,"class":45},60,""]