IV azithromycin versus meropenem for extensively drug-resistant (XDR) enteric fever
Official title: "Comparing Efficacy of Intravenous Azithromycin and Meropenem for Extensively Drug-Resistant Enteric Fever: A Randomized Controlled Trial" (Pilot Study)
Run by Indus Hospital and Health Network · NCT07314281 · Data updated 2026-11-12
This tests whether intravenous azithromycin or meropenem works better for people aged 1–70 with blood-culture-confirmed XDR enteric fever.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Indus Hospital and Health Network Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Status | Recruiting |
| Started | April 22, 2025 |
| Main results expected | January 15, 2027 |
| Study ends | January 15, 2027 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT07314281 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 1–70 with blood-culture-confirmed XDR Salmonella Typhi who meet ECG, liver/kidney, pregnancy, and allergy safety criteria and can receive inpatient IV therapy.
✕Probably not a fit
Patients who are pregnant or lactating, have positive pregnancy tests, known hypersensitivity to macrolides or carbapenems, or significant ECG/hepatic/renal abnormalities are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomised, phase 4 interventional comparison enrolls patients with blood culture–confirmed XDR Salmonella Typhi and allocates them to receive intravenous azithromycin or meropenem for 14 days. Clinical signs, temperature, ECG, liver and kidney tests are monitored frequently, with blood cultures checked on day 3 and again on day 7 if needed. Primary endpoints include clinical resolution, fever defervescence, and blood culture clearance; secondary measures include cost-effectiveness and emerging drug resistance. Treatment modifications or discontinuation are specified for hypersensitivity or other adverse events, and married women must have a negative pregnancy test at baseline.
Why it matters
Potential benefit: If successful, the trial may show that IV azithromycin is an effective and potentially lower-cost alternative to meropenem for treating XDR enteric fever.
How similar studies have gone: Prior studies have shown azithromycin can be effective for drug-resistant typhoid and meropenem is used for severe XDR cases, but head-to-head randomized comparisons between the two are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants will enrolled on following criteria * Voluntarily sign the written informed consent * Patient's of age 1-70 years with clinically suspected on physician decision or XDR enteric fever confirmed by blood culture and sensitivity tests. * Married females with negative pregnancy test. * No history of cardiac issues with ECG abnormalities, cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use. * Patients having no hypersensitivity (skin rashes, anaphylaxis) to azithromycin and meropenem * Patients on concomitant medication, having no drug-drug interaction with meropenem and azithromycin will be included in study. Exclusion Criteria: * Participants will excluded on following criteria * Pregnant, lactating women or women of childbearing age with positive pregnancy test at baseline. * Patients with known hypersensitivity (skin rashes, anaphylaxis) to azithromycin, meropenem, or any other macrolide or carbapenem antibiotics. * 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 * Patients with history of cardiac disorder with ECG abnormalities and history of cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use will be excluded. * Patients on continuous medication, having drug-drug interaction with meropenem and azithromycin will be excluded.
Where it's running
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Indus Hospital & Health Network - Mian Campus
Karachi, Sindh, Pakistan Recruiting
Study contacts
- Principal investigator: muhammad hamid — Indus Hospital and Health Network
- Study coordinator: muhammad hamid, PharmD
- Email: hamidryk155@gmail.com
- Phone: +923017697904
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This study is trying to find out if looking at gene responses in feverish patients can help doctors quickly tell if they have enteric fever or another infection, especially in places with limited resources.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.