An interventional study of meropenem and Meropenem and azithromycin combination in Typhoid Fever, sponsored by Iqra Asghar Ali. Not yet recruiting at 1 site in Pakistan. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Iqra Asghar Ali · Not applicable, Interventional, and Treatment
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."
Typhoid fever caused by Salmonella enterica serovar Typhi remains a major public health challenge in low- and middle-income countries. The emergence of extensively drug-resistant (XDR) strains, resistant to first-line agents, fluoroquinolones, and third-generation cephalosporins, has severely limited treatment options. In Pakistan, outbreaks of XDR typhoid have been reported since 2016, with thousands of confirmed cases in Karachi and Hyderabad. Current guidelines recommend carbapenems and azithromycin as the remaining effective agents, but the optimal regimen remains uncertain.
This randomized controlled trial will compare single-drug therapy (meropenem) with combination therapy (meropenem plus azithromycin) in pediatric patients aged 2-16 years with culture-confirmed XDR typhoid fever admitted to the Children's Hospital, Lahore. Ninety-four patients will be enrolled and randomly assigned to either treatment group using concealed allocation. Meropenem will be administered intravenously at 30 mg/kg/dose every 8 hours(maximum 2g per dose)while azithromycin will be given orally at 20 mg/kg/day according to hospital protocol. The primary endpoint is time to defervescence, defined as sustained resolution of fever for more than 48 hours. Secondary endpoints include duration of hospital stay and complication rates.
76 studies on the registry are indexed under Typhoid Fever; 11 are open to participants now.
This study's planned enrollment of 94 is below the median of 147 across 65 interventional studies indexed under Typhoid Fever.
Browse Typhoid Fever studies →This is the only study on the registry with Iqra Asghar Ali as lead sponsor.
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Children aged 2-16 years
obtained from parent/guardian
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive meropenem IV, 30mg/kg/dose every 8 hours(maximum 2g per dose)
Drug: meropenem
Patients receive meropenem 30mg/kg/dose every 8 hours (maximum 2g per dose) IV plus oral azithromycin, 20 mg/kg/day.
Drug: Meropenem and azithromycin combination
IV meropenem, 100 mg/kg/day TDS
Drug pages: Meropenem · Azithromycin
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
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Meropenem · Azithromycin