[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610239":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":29,"locations":26,"responsibleParty":39,"collaborators":26,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":26,"eligibilityCriteria":48,"healthyVolunteers":45,"sex":49,"minAge":50,"maxAge":26,"enrollmentInfo":51,"targetDuration":26,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":26,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":26},{"fullName":5,"class":6},"Hospital Civil de Guadalajara","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TMP\u002FSMX","EXPERIMENTAL","Drug: Trimethoprim-Sulfamethoxazole (TMP\u002FSMX) 160\u002F800 mg tablets every 48 hours\n\n* Dosing: One tablet by mouth, Trimethoprim-Sulfamethoxazole (TMP\u002FSMX) 160\u002F800 mg tablets every 48 hours, for 90 days post-discharge.\n* Other names: cotrimoxazole, sulfamethoxazole-trimethoprim. Bactrim F",[13],"Drug: Drug: Trimethoprim-Sulfamethoxazole (TMP\u002FSMX) 160\u002F800 mg tablets every 48 hours",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Drug: Placebo (matching oral tablet)\n\n• Dosing: Matching schedule for 90 days post-discharge.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Drug: Trimethoprim-Sulfamethoxazole (TMP\u002FSMX) 160\u002F800 mg tablets every 48 hours","Drug: Trimethoprim-Sulfamethoxazole (TMP\u002FSMX) 160\u002F800 mg tablets every 48 hours\n\n• Dosing: One tablet by mouth, Trimethoprim-Sulfamethoxazole (TMP\u002FSMX) 160\u002F800 mg tablets every 48 hours, for 90 days post-discharge.",[9],null,{"type":6,"name":15,"description":17,"armGroupLabels":28,"otherNames":26},[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},"Jonathan Samuel Chavez Iñiguez, Dr.","CONTACT","+523313299609","jonarchi_10@hotmail.com",{"name":36,"role":32,"phone":37,"phoneExt":26,"email":38},"Luz Alcantar, Dr.","+3311773864","luzalcantarvallin@gmail.com",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jonathan Samuel Chavez Iñiguez","Head of nephrology","100610239","phase-2-trimethoprim-sulfamethoxazole-tmpsmx-prophylaxis-after-acute-kidney-injury-to-prevent-post-discharge-infections-100610239",false,"NCT07224997","Trimethoprim-Sulfamethoxazole (TMP\u002FSMX) Prophylaxis After Acute Kidney Injury to Prevent Post-discharge Infections","Inclusion Criteria\n\n* Age ≥18 years.\n* Index hospitalization complicated by AKI (KDIGO criteria) prior to discharge.\n* Planned discharge to community\u002Frehabilitation with capacity for follow-up.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Known allergy to sulfonamides or TMP\u002FSMX.\n* Pregnancy or breastfeeding.\n* Severe hepatic disease (e.g., Child-Pugh C).\n* Severe cytopenia (e.g., ANC \\\u003C1.0×10⁹\u002FL or platelets \\\u003C50×10⁹\u002FL).\n* Baseline hyperkalemia (\\>5.5 mmol\u002FL) not correctable prior to randomization.\n* Concomitant medications with high-risk interactions not amenable to dose\u002Fmonitoring (per protocol).\n* Current systemic antimicrobial therapy planned for \\>14 days after discharge (prophylaxis not indicated).\n* Inability to adhere to study procedures or follow-up.","ALL","18 Years",{"count":52,"type":53},120,"ESTIMATED","INTERVENTIONAL",[56],"PHASE2","Official Title\n\nTrimethoprim-Sulfamethoxazole (TMP\u002FSMX) Prophylaxis After Acute Kidney Injury to Prevent Post-discharge Infections: A Randomized, Double-Blind, Placebo-Controlled Trial\n\nBrief Summary\n\nAcute kidney injury (AKI) is commonly followed by infections after hospital discharge. This randomized, double-blind, placebo-controlled trial will test whether prophylactic TMP\u002FSMX reduces post-discharge infections in adults recently hospitalized with AKI. Participants will be randomized 1:1 to TMP\u002FSMX or matching placebo and followed for 6 months. The primary outcome is the proportion of participants who develop any infection within 90 days after discharge. Secondary outcomes include time to first infection, infection-related hospitalization, mortality, safety\u002Fadverse events, and healthcare utilization through 180 days.\n\nDetailed Description\n\nAdults discharged after an index hospitalization complicated by AKI are at elevated infection risk. This trial evaluates whether short-term TMP\u002FSMX prophylaxis reduces 90-day infections. After consent and eligibility confirmation near discharge, participants are randomized (1:1) to receive TMP\u002FSMX or matching placebo with double-blind masking (participant and outcome assessor). Dosing is standardized per protocol. We will ascertain infections via structured follow-up, medical record review, and adjudication by blinded assessors. Safety monitoring will capture adverse events (e.g., rash, cytopenias, hyperkalemia). Analyses follow intention-to-treat.\n\nStudy Design\n\n* Study Type: Interventional (Clinical Trial)\n* Primary Purpose: Prevention\n* Allocation: Randomized (1:1)\n* Intervention Model: Parallel Assignment\n* Masking: Double-blind (Participant, Outcomes Assessor)\n* Estimated Enrollment: 60 patients per group\n* Study Start Date: December 2025\n* Primary Completion Date (Anticipated): January 2027 (last patient reaches 90-day outcome)\n* Study Completion Date (Anticipated): July 2028 (last patient completes 180-day follow-up)\n\nArms \\& Interventions\n\nExperimental: TMP\u002FSMX\n\n* Intervention: Drug: Trimethoprim-Sulfamethoxazole (TMP\u002FSMX) 160\u002F800 mg tablets every 48 hours\n* Dosing: One tablet by mouth, Trimethoprim-Sulfamethoxazole (TMP\u002FSMX) 160\u002F800 mg tablets every 48 hours, for 90 days post-discharge.\n* Other names: cotrimoxazole, sulfamethoxazole-trimethoprim. Bactrim F\n\nPlacebo Comparator: Placebo\n\n* Intervention: Drug: Placebo (matching oral tablet)\n* Dosing: Matching schedule for 90 days post-discharge.\n\nConcomitant care: Allowed per treating clinician. Drug interactions and lab monitoring handled per protocol.\n\nOutcome Measures\n\nPrimary Outcome\n\n• Any infection within 90 days after discharge Time Frame: Day 0 (discharge) to Day 90 Measure: Proportion of participants with ≥1 infection, defined by clinical diagnosis requiring documentation (e.g., UTI, pneumonia, SSTI, bloodstream infection) and\u002For antimicrobial treatment initiation.\n\nSecondary Outcomes\n\n1. Time to first infection (days) within 90 days.\n2. Infection-related hospitalization within 90 and 180 days.\n3. All-cause mortality at 90 and 180 days.\n4. Emergency department visits or unplanned readmissions within 180 days.\n5. Antibiotic-related adverse events (rash, cytopenia, creatinine rise ≥0.3 mg\u002FdL, hyperkalemia ≥5.5 mmol\u002FL) through 180 days.\n6. C. difficile infection within 180 days.\n7. Recurrent AKI (KDIGO criteria) within 180 days.\n8. Medication adherence (pill counts and\u002For self-report) over 90 days.\n9. Major adverse kidney events over 90 days.\n\nEligibility Criteria\n\nInclusion Criteria\n\n* Age ≥18 years.\n* Index hospitalization complicated by AKI (KDIGO criteria) prior to discharge.\n* Planned discharge to community\u002Frehabilitation with capacity for follow-up.\n* Ability to provide informed consent.\n\nExclusion Criteria\n\n* Known allergy to sulfonamides or TMP\u002FSMX.\n* Pregnancy or breastfeeding.\n* Severe hepatic disease (e.g., Child-Pugh C).\n* Severe cytopenia (e.g., ANC \\\u003C1.0×10⁹\u002FL or platelets \\\u003C50×10⁹\u002FL).\n* Baseline hyperkalemia (\\>5.5 mmol\u002FL) not correctable prior to randomization.\n* Concomitant medications with high-risk interactions not amenable to dose\u002Fmonitoring (per protocol).\n* Current systemic antimicrobial therapy planned for \\>14 days after discharge (prophylaxis not indicated).\n* Inability to adhere to study procedures or follow-up.\n\nContacts\u002FLocations\n\n* Lead Sponsor \u002F Responsible Party: Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara, servicio de Nefrología\n* Principal Investigator: Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara, servicio de Nefrología, 3313299609\n* Study Locations: Hospital Civil de Guadalajara, servicio de Nefrología, Hospital 278, colonia el Retiro. Guadalajara. Jalisco.\n\nEthics and Oversight\n\n* Conducted in accordance with the Declaration of Helsinki and ICH-GCP.\n* IRB\u002FEthics approval: Comité de etica en investigacion, Protocol CEI 214\u002F25, Approval : October 16, 2025.\n* Written informed consent obtained from all participants prior to any study procedures.\n* Data",[59,60,61],"Acute Kidney Injuries","Acute Kidney Disease","Acute Kidney Injury (AKI)","NOT_YET_RECRUITING","2025-11-02",{"date":65,"type":66},"2025-11-05","ACTUAL",{"date":68,"type":53},"2025-12-01",{"date":70,"type":53},"2027-07-01",{"name":5,"class":6}]