Extensively Drug-Resistant Typhoid FeverPhase 4XDR-TYNCT07445282
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 Phase 4 study testing Meropenem and Azithromycin + Metronidazole in people with Extensively Drug-Resistant Typhoid Fever and Typhoid Fever, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Extensively Drug-Resistant Typhoid Fever, Typhoid Fever, Salmonella Typhi Infection
- What is being tested?
- Meropenem and Azithromycin + Metronidazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 14 May 2025to 14 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 months to under 5 years
- Blood culture-confirmed extensively drug-resistant Salmonella Typhi infection
- Axillary temperature ≥100°F
- Uncomplicated typhoid fever
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sheikh Zayed Hospital, Rahim Yar Khan, Pakistan
Rahim Yar Khan, Punjab Province, 64200
About this study
Official title: Enhanced Clinical Recovery With Meropenem-Azithromycin Combination Therapy in Extensively Drug-Resistant Typhoid Feve
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
Read the 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.
- Being tested
- Meropenem, Azithromycin + Metronidazole
- Keywords
- XDR Typhoid, Meropenem, Azithromycin, Pediatric, Randomized Controlled Trial
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
Intravenous meropenem administered at a dose of 20-40 mg/kg every 8 hours.
Azithromycin + MetronidazoleDrug
Participants receive intravenous meropenem (20-40 mg/kg every 8 hours) combined with oral azithromycin at a dose of 20 mg/kg/day.
| Study group | Role | What they receive |
|---|---|---|
| Meropenem Monotherapy | Experimental | Participants receive intravenous meropenem at a dose of 20-40 mg/kg every 8 hours. Receives: Drug: Meropenem |
| Meropenem Plus Azithromycin | Experimental | Participants receive intravenous meropenem (20-40 mg/kg every 8 hours) combined with oral azithromycin at a dose of 20 mg/kg/day. Receives: Drug: Meropenem; Drug: Azithromycin + Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Defervescence
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.
Measured: From initiation of antibiotic treatment until achievement of sustained defervescence (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start14 May 2025
- Primary completion14 Nov 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensively Drug-Resistant Typhoid FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in parallel groups to receive either meropenem monotherapy or meropenem combined with azithromycin.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fawad Ahmad, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445282
- Sponsor's protocol ID
- 110/SZMC/SZH
- Other IDs
- 110/SZMC/SZH
- Acronym
- XDR-TY
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Clinical Recovery With Meropenem-Azithromycin Combination Therapy in Extensively Drug-Resistant Typhoid Feve
- ClinicalTrials.gov ID
- NCT07445282
- Acronym / sponsor ID
- XDR-TY / 110/SZMC/SZH
- Keywords
- XDR Typhoid, Meropenem, Azithromycin, Pediatric, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 14 May 2025 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in parallel groups to receive either meropenem monotherapy or meropenem combined with azithromycin.
| Arm | Type | Receives |
|---|---|---|
| Meropenem Monotherapy | Experimental | Drug: MeropenemParticipants receive intravenous meropenem at a dose of 20-40 mg/kg every 8 hours. |
| Meropenem Plus Azithromycin | Experimental | Drug: Meropenem, Drug: Azithromycin + MetronidazoleParticipants receive intravenous meropenem (20-40 mg/kg every 8 hours) combined with oral azithromycin at a dose of 20 mg/kg/day. |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6 months to under 5 years
- Blood culture-confirmed extensively drug-resistant Salmonella Typhi infection
- Axillary temperature ≥100°F
- Uncomplicated typhoid fever
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeropenemIntravenous meropenem administered at a dose of 20-40 mg/kg every 8 hours. | Drug | Meropenem Monotherapy, Meropenem Plus Azithromycin |
| Azithromycin + MetronidazoleParticipants receive intravenous meropenem (20-40 mg/kg every 8 hours) combined with oral azithromycin at a dose of 20 mg/kg/day. | Drug | Meropenem Plus Azithromycin |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
Related trials for Extensively Drug-Resistant Typhoid Fever
Not yet recruiting
COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE
Typhoid Fever
RecruitingPhase 4
Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever
Enteric Fever
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meropenem and Azithromycin + Metronidazole in people with Extensively Drug-Resistant Typhoid Fever and Typhoid Fever, run by Sheikh Zayed Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Defervescence (time frame: From initiation of antibiotic treatment until achievement of sustained defervescence (up to 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.