Health TrialsbyHealthPanel

COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE

ConditionTyphoid Fever
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-16
SponsorIqra Asghar Ali

About this trial

This randomized controlled trial will compare the effectiveness of single-drug therapy (meropenem) versus combination therapy (meropenem plus azithromycin) in children aged 2-16 years diagnosed with extensively drug-resistant (XDR) typhoid fever at the Children's Hospital, Lahore. A total of 94 patients will be enrolled and randomly assigned to either treatment group. The primary outcome is time to defervescence, defined as sustained resolution of fever for more than 48 hours. Secondary outcomes include duration of hospital stay and complication rates. The study aims to provide evidence to guide optimal management of XDR typhoid in pediatric populations."

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Children aged 2-16 years

Culture-confirmed XDR typhoid fever (resistant to first-line agents, fluoroquinolones, and third-generation cephalosporins)

Admitted to Children's Hospital & Institute of Child Health, Lahore

Disqualifiers

Age <2 years or >16 years

Known allergy or contraindication to meropenem or azithromycin

Presence of severe comorbidities (e.g., congenital heart disease, chronic renal failure, immunodeficiency)

Patients already receiving carbapenem or azithromycin therapy prior to enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • meropenem

    Drug

    IV meropenem, 100 mg/kg/day TDS

  • Meropenem and azithromycin combination

    Drug

    combination drug therapy will consist of meropenem intravenously at a dose of 20-40 mg/kg/dose every 8 hours(maximum 2g per dose) plus azithromycin (orally) at 20 mg/kg/day

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Meropenem Monotherapy Arm 1Experimental treatment 1 intervention
Group B: Arm 2 Title: Meropenem + Azithromycin CombinationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Name: Time to defervescence Description: Number of days from initiation of appropriate antimicrobial therapy until sustained resolution of fever (<100°F for >48 hours). Time Frame: From start of antibiotic therapy upto 10-14 days

Description: Number of days from initiation of appropriate antimicrobial therapy until sustained resolution of fever (\<100°F for \>48 hours).

Time frame
Time Frame: 10-14days after initiation of treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Iqra Asghar Ali

Lead sponsor

University of Child Health Sciences and Children's Hospital, Lahore

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: