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NCT Number: NCT07445282

This Randomized Controlled Trial Evaluates the Comparative Efficacy of Intravenous Meropenem Alone Versus Intravenous Meropenem Combined With Oral Azithromycin in Children Aged 6 Months to Under 5 Years Diagnosed With Blood Culture-confirmed Extensively Drug-resistant Uncomplicated Typhoid Fever

This randomized controlled trial evaluates the comparative efficacy of intravenous meropenem alone versus intravenous meropenem combined with oral azithromycin in children aged 6 months to under 5 years diagnosed with blood culture-confirmed extensively drug-resistant uncomplicated typhoid fever. A total of 90 participants are randomly assigned in a 1:1 ratio to receive either meropenem monotherapy or combination therapy. The primary outcome is time to defervescence, defined as the number of days required for body temperature to fall below 100°F and remain so for at least 48 consecutive hours after initiation of antibiotic treatment. Participants are monitored daily during hospitalization for clinical improvement and adverse drug reactions

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Key information

Conditions

Extensively Drug-Resistant Typhoid Fever Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections Salmonella Infections Salmonella Typhi Infection Typhoid Fever

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sheikh Zayed Hospital, Rahim Yar Khan, Pakistan

Rahim Yar Khan, Punjab Province, 64200, Pakistan

About this study

This interventional randomized controlled trial compares intravenous meropenem alone with intravenous meropenem combined with oral azithromycin for the treatment of extensively drug-resistant uncomplicated typhoid fever in children aged 6 months to under 5 years. A total of 90 participants are randomly assigned in equal numbers to receive either meropenem monotherapy or combination therapy. The primary outcome measure is time to defervescence, defined as the time from initiation of antibiotic treatment to reduction of axillary temperature below 100°F maintained for at least 48 consecutive hours. Participants are monitored daily during hospitalization for clinical response and adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 6 months to under 5 years
  • Blood culture-confirmed extensively drug-resistant Salmonella Typhi infection
  • Axillary temperature ≥100°F
  • Uncomplicated typhoid fever

Exclusion criteria

  • Complicated typhoid fever (intestinal perforation, gastrointestinal bleeding, encephalopathy, or shock)
  • Known hypersensitivity to meropenem or azithromycin
  • Coexisting infections requiring additional antimicrobial therapy
  • Chronic conditions including malnutrition or immunodeficiency
  • Congenital or acquired heart disease

Treatment and study plan

Meropenem

Drug

Intravenous meropenem administered at a dose of 20-40 mg/kg every 8 hours.

Azithromycin + Metronidazole

Drug

Participants receive intravenous meropenem (20-40 mg/kg every 8 hours) combined with oral azithromycin at a dose of 20 mg/kg/day.

Primary outcomes

  1. Time to Defervescence

    Time frame: From initiation of antibiotic treatment until achievement of sustained defervescence (up to 14 days)

    Time to defervescence is defined as the number of days from initiation of antibiotic therapy until the axillary body temperature falls below 100°F and remains below this threshold for at least 48 consecutive hours.

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Medical College

Other Gov

Registry information

Official study title

Enhanced Clinical Recovery With Meropenem-Azithromycin Combination Therapy in Extensively Drug-Resistant Typhoid Feve

Acronym: XDR-TY

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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