Extensively Drug-Resistant Typhoid Fever, Salmonella Typhi Infection, Typhoid Fever
Conditions
Keywords
XDR Typhoid, Meropenem, Azithromycin, Pediatric, Randomized Controlled Trial
Brief summary
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
Detailed description
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.
Interventions
DRUGMeropenem
Intravenous meropenem administered at a dose of 20-40 mg/kg every 8 hours.
Participants receive intravenous meropenem (20-40 mg/kg every 8 hours) combined with oral azithromycin at a dose of 20 mg/kg/day.
Sponsors
Sheikh Zayed Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomly assigned in parallel groups to receive either meropenem monotherapy or meropenem combined with azithromycin.
Eligibility
Sex/Gender
ALL
Age
6 Months to 4 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Defervescence | 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. |
Countries
Pakistan
Outcome results
None listed