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)
Indus Hospital and Health Network
40 participants
Apr 22, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria6
- 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.
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Interventions
Azithromycin 1g IV loading dose then 500mg IV OD
Meropenem 1000 mg IV Q8H
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07314281