Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever

NCT07314281 | Recruiting Phase 4

• 1 other identifier: IHHN_IRB_2024_10_010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

• To evaluate the fever defervescence and Salmonella Typhi eradication
• To evaluate the cost-effectiveness of intravenous azithromycin versus meropenem in treating XDR enteric fever.
• Exploratory Objectives:
• To evaluate the drug resistance against intravenous azithromycin versus in treating XDR enteric fever.

Conditions

Enteric Fever

Outcome Measures

Primary Outcomes (2)

• Fever defervescence

  Proportion of participants with fever defervescence of temperature 37 ℃ at Mid-treatment outcome (Day 7). Temperature will be monitored and documented in degrees centigrade (°C)

  Mid-treatment outcome (Day 7)

• Salmonella Typhi eradication

  Proportion of participants with Salmonella Typhi eradication in Blood culture test on day 3. After start of intervention, a clearance of blood culture will be monitor at day 3. if Salmonella Typhi in blood culture of day 3 will not eradicate, a second blood culture will be done on Day 7.

  Mid-treatment outcome (Day 7)

Secondary Outcomes (4)

• Hospital Admission Days

  End-of-treatment outcome (Day 14)

• Cumulative Treatment Duration

  End-of-treatment outcome (Day 14)

• Adverse Events Monitoring

  Mid-treatment outcome (Day 7)

• Antimicrobial Resistance and Cost of treatment

  End-of-treatment outcome (Day 14)

Study Arms (2)

Meropenem arm

ACTIVE COMPARATOR

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.

Drug: Meropenem Injection

Azithromycin arm

EXPERIMENTAL

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

Drug: Azithromycin

Interventions

Azithromycin DRUG

Azithromycin 1g IV loading dose then 500mg IV OD

Also known as: Experimental group

Azithromycin arm

Meropenem Injection DRUG

Meropenem 1000 mg IV Q8H

Meropenem arm

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Indus Hospital and Health Network: lead

Study Sites (1)

Indus Hospital & Health Network - Mian Campus

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Typhoid Fever

Interventions

Azithromycin; Meropenem

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• muhammad hamid

  Indus Hospital and Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

muhammad hamid, PharmD

CONTACT

+923017697904; hamidryk155@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized, controlled, parallel open-label pilot study

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: January 2, 2026
• Study Start: April 22, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)