Actively Recruiting
Comparing Efficacy of Intravenous Azithromycin and Meropenem for Extensively Drug-Resistant Enteric Fever: A Randomized Controlled Trial (Pilot Study)
Led by Indus Hospital and Health Network · Updated on 2026-05-08
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of intravenous azithromycin compared to meropenem in treating extensively drug-resistant (XDR) enteric fever. The study also looks at fever reduction, bacterial eradication, cost-effectiveness, and drug resistance related to these treatments. It is a phase 4 randomized controlled trial sponsored by Indus Hospital and Health Network. Participants will be randomly assigned to one of two groups. The standard care group starts with meropenem 1g intravenously every 8 hours, transitioning to oral azithromycin once stable. The intervention group receives azithromycin intravenously with an initial 1g dose followed by 500mg daily, then switches to oral azithromycin after stability. Both treatments continue intravenously until 24 hours after fever resolution, with a total treatment duration of 14 days. During the study, patients undergo regular monitoring including blood cultures on day 3 and day 7 to check bacterial clearance, and vital signs are checked three times daily. ECG, liver function tests, and clinical assessments are done by day 7 to evaluate progress and any need for treatment changes. Researchers measure fever defervescence and Salmonella Typhi eradication as primary outcomes, alongside monitoring adverse events, hospital stay length, treatment duration, and cost-effectiveness over the course of treatment.
CONDITIONS
Brief Title
Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the written informed consent
- Age between 1 and 70 years with clinically suspected or confirmed extensively drug-resistant enteric fever
- Married females with a negative pregnancy test
- No history of cardiac issues with ECG abnormalities or hepatic dysfunction linked to prior azithromycin use
- No hypersensitivity to azithromycin or meropenem
- No drug interactions with meropenem or azithromycin when on other medications
You will not qualify if you...
- Pregnant or breastfeeding women, or women of childbearing age with positive pregnancy test at baseline
- Known hypersensitivity to azithromycin, meropenem, or related antibiotics
- Blood culture positive for multidrug-resistant Salmonella Typhi
- History of cardiac disorders with ECG abnormalities or hepatic dysfunction related to azithromycin use
- Taking medications that interact with meropenem or azithromycin continuously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 14 days
Participants receive intravenous meropenem or azithromycin treatment initially, transitioning to oral azithromycin once stabilized. Treatment includes monitoring vital signs multiple times daily and blood culture checks to assess infection clearance.
Daily monitoring visits during treatment with blood culture checks on Day 3 and possibly Day 7; ECG and liver function tests on Day 7
Trial Site Locations
Total: 1 location
1
Indus Hospital & Health Network - Mian Campus
Karachi, Sindh, Pakistan
Actively Recruiting
Research Team
M
muhammad hamid, PharmD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here