Comparing Efficacy of Intravenous Azithromycin and Meropenem for Extensively Drug-Resistant Enteric Fever: A Randomized Controlled Trial (Pilot Study)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 70
Healthy Volunteers: f
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• 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.
Locations
Other Locations
Pakistan
Indus Hospital & Health Network - Mian Campus
RECRUITING
Karachi
Contact Information
Primary
muhammad hamid, PharmD
hamidryk155@gmail.com
+923017697904
Time Frame
Start Date:2025-04-22
Estimated Completion Date:2025-12-31
Participants
Target number of participants:40
Treatments
Active_comparator: Meropenem arm
For the standard care protocol, patients are initially treated with meropenem 1g intravenously every 8 hours. Once their condition stabilizes , treatment is transitioned to oral azithromycin. The transition involves administering a first dose of azithromycin 1g orally, followed by a daily dose of 500mg orally. Intravenous meropenem will continue until 24 hours after the patient's fever has resolved, after which the treatment will switch to oral azithromycin.
Experimental: Azithromycin arm
In the intervention group, patients begin with azithromycin 1g administered intravenously for the initial dose, followed by a daily dose of 500mg intravenously. When the patient's condition stabilizes, the treatment will transition to oral azithromycin, starting with a 1g oral dose and continuing with 500mg orally once daily. Intravenous azithromycin will be maintained until 24 hours after the patient's fever has resolved, after which the treatment will switch to oral azithromycin