Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever

Recruiting now · Phase 4

Conditions studied: Enteric Fever

In brief

1. Primary Objective: o To evaluate the efficacy of intravenous azithromycin compared with meropenem in the treatment of extensively drug-resistant (XDR) enteric fever. 2. Secondary Objectives: * To evaluate the fever defervescence and Salmonella Typhi eradication * To evaluate the cost-effectiveness of intravenous azithromycin versus meropenem in treating XDR enteric fever. 3. Exploratory Objectives: * To evaluate the drug resistance against intravenous azithromycin versus in treating XDR enteric fever.

Key facts

Study ID

NCT07314281

Run by

Indus Hospital and Health Network

People needed

40

Starts

2025-04-22

Expected to finish

2027-01-15

Last updated by the study team

2026-05-08

Who can join

Age: 1 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Indus Hospital & Health Network - Mian Campus — Karachi, Sindh, Pakistan (enrolling)

Full record on ClinicalTrials.gov

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