[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617104":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":62,"collaborators":32,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":32,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":32,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Indus Hospital and Health Network","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Meropenem arm","ACTIVE_COMPARATOR","For the standard care protocol, patients are initially treated with meropenem 1g intravenously every 8 hours. Once their condition stabilizes , treatment is transitioned to oral azithromycin. The transition involves administering a first dose of azithromycin 1g orally, followed by a daily dose of 500mg orally. Intravenous meropenem will continue until 24 hours after the patient's fever has resolved, after which the treatment will switch to oral azithromycin.",[13],"Drug: Meropenem Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Azithromycin arm","EXPERIMENTAL","In the intervention group, patients begin with azithromycin 1g administered intravenously for the initial dose, followed by a daily dose of 500mg intravenously. When the patient's condition stabilizes, the treatment will transition to oral azithromycin, starting with a 1g oral dose and continuing with 500mg orally once daily. Intravenous azithromycin will be maintained until 24 hours after the patient's fever has resolved, after which the treatment will switch to oral azithromycin",[19],"Drug: Azithromycin",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Azithromycin","Azithromycin 1g IV loading dose then 500mg IV OD",[15],[27],"Experimental group",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Meropenem Injection","Meropenem 1000 mg IV Q8H",[9],null,[34],{"name":35,"affiliation":5,"role":36},"muhammad hamid","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"muhammad hamid, PharmD","CONTACT","+923017697904","hamidryk155@gmail.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":32,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Indus Hospital & Health Network - Mian Campus","RECRUITING","Karachi","Sindh","Pakistan","PK",{"type":52,"coordinates":53},"Point",[54,55],67.0104,24.8608,{"lat":55,"lon":54},[58],{"name":39,"role":40,"phone":59,"phoneExt":60,"email":61},"03017697904","2529","muhammad.hamid@tih.org.pk",{"type":36,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Muhammad Hamid Hanif","Principal Investigator","100617104","phase-4-meropenem-vs-azithromycin-efficacy-in-case-xdr-enteric-fever-100617104",false,"NCT07314281","Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever","\"Comparing Efficacy of Intravenous Azithromycin and Meropenem for Extensively Drug-Resistant Enteric Fever: A Randomized Controlled Trial\" (Pilot Study)","Inclusion Criteria:\n\n* Participants will enrolled on following criteria\n\n  * Voluntarily sign the written informed consent\n  * Patient's of age 1-70 years with clinically suspected on physician decision or XDR enteric fever confirmed by blood culture and sensitivity tests.\n  * Married females with negative pregnancy test.\n  * No history of cardiac issues with ECG abnormalities, cholestatic jaundice\u002Fhepatic dysfunction associated with prior azithromycin use.\n  * Patients having no hypersensitivity (skin rashes, anaphylaxis) to azithromycin and meropenem\n  * Patients on concomitant medication, having no drug-drug interaction with meropenem and azithromycin will be included in study.\n\nExclusion Criteria:\n\n* Participants will excluded on following criteria\n\n  * Pregnant, lactating women or women of childbearing age with positive pregnancy test at baseline.\n  * Patients with known hypersensitivity (skin rashes, anaphylaxis) to azithromycin, meropenem, or any other macrolide or carbapenem antibiotics.\n  * Blood culture and sensitivity tests reported positive culture with MDR S. typhi (non-susceptibility to at least one agent in three or more antimicrobial categories,) o\n  * Patients with history of cardiac disorder with ECG abnormalities and history of cholestatic jaundice\u002Fhepatic dysfunction associated with prior azithromycin use will be excluded.\n  * Patients on continuous medication, having drug-drug interaction with meropenem and azithromycin will be excluded.","ALL","1 Year","70 Years",{"count":76,"type":77},40,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","1. Primary Objective:\n\n   o To evaluate the efficacy of intravenous azithromycin compared with meropenem in the treatment of extensively drug-resistant (XDR) enteric fever.\n2. Secondary Objectives:\n\n   * To evaluate the fever defervescence and Salmonella Typhi eradication\n   * To evaluate the cost-effectiveness of intravenous azithromycin versus meropenem in treating XDR enteric fever.\n3. Exploratory Objectives:\n\n   * To evaluate the drug resistance against intravenous azithromycin versus in treating XDR enteric fever.",[83],"Enteric Fever","2026-05-05",{"date":86,"type":87},"2026-05-08","ACTUAL",{"date":89,"type":87},"2025-04-22",{"date":91,"type":77},"2027-01-15",{"name":5,"class":6},1]