IV azithromycin versus meropenem for extensively drug-resistant (XDR) enteric fever

"Comparing Efficacy of Intravenous Azithromycin and Meropenem for Extensively Drug-Resistant Enteric Fever: A Randomized Controlled Trial" (Pilot Study)

This tests whether intravenous azithromycin or meropenem works better for people aged 1–70 with blood-culture-confirmed XDR enteric fever.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 1 Year to 70 Years
• Sex: All
• Sponsor: Indus Hospital and Health Network (other)
• Locations: 1 site (Karachi, Sindh)
• Trial ID: NCT07314281 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Karachi, Sindh

• 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

Conditions: Enteric Fever