Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever (NCT07314281) | Clinical Trial Compass
RecruitingPhase 4
Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever
Pakistan40 participantsStarted 2025-04-22
Plain-language 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.
Who can participate
Age range1 Year – 70 Years
SexALL
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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.