A Phase 4 interventional study of Azithromycin and Meropenem Injection in Enteric Fever, sponsored by Indus Hospital and Health Network. Recruiting at 1 site in Pakistan. Open to participants aged 1 Year to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Indus Hospital and Health Network · Phase 4, Interventional, and Treatment
Primary Objective:
o To evaluate the efficacy of intravenous azithromycin compared with meropenem in the treatment of extensively drug-resistant (XDR) enteric fever.
Secondary Objectives:
Exploratory Objectives:
Screening Period:
Patients with positive blood culture of XDR S. typhi underwent further screening for inclusion in study by physician. Before randomization, ECG monitoring, investigations including serum creatinine, liver function test, pregnancy test for married female participants will be done. If patient meet eligibility criteria and physician enrolled, randomization will be done and treatment will be allocated.
Treatment Period:
During treatment period, on D3 clearance blood culture will be sent to check bacterial eradication or sterility of blood. Temperature, blood pressure, pulse will be monitored three times a day. If D3 blood culture and sensitivity report is still positive, second clearance blood culture will be sent on D7. On D7 ECG and LFTs will reassessed. On D7 of treatment detailed clinical assessment will be done in order to evaluate improvement in clinical condition and need of therapy modification "Discontinuation of treatment" based on the list of all terms and condition including hypersensitivity reaction, any adverse event. Total treatment duration will be 14 days. Resolution of symptoms, fever defervescence and blood culture clearance will be consider as study end point.
Randomization and Blinding:
The participant meeting all the inclusion and exhibits no characteristics of exclusion criteria will be eligible to enroll in the study. The written informed consent will be taken and signed ICF will be obtained from participant. The participants will be enrolled in the study based on randomization. The randomization will be done by using randomization allocation software. The office of research and innovation (ORIC) personnel independent from the study will randomize and allocate treatment group. This is an open-label study; thus, both the investigators and participants will be aware of the treatment allocation after randomization. Principle investigator will enroll participants in collaboration with physician. The office of research and innovation (ORIC) personnel will develop envelope containing allocation sequence and treatment option either standard treatment or intervention treatment. Envelop will hand over to physician and will assign treatment option to participants.
Study treatment and Intervention:
For the standard care protocol, patients are initially treated with meropenem 1g intravenously every 8 hours. Once their condition stabilizes , treatment is transitioned to oral azithromycin. The transition involves administering a first dose of azithromycin 1g orally, followed by a daily dose of 500mg orally. Intravenous meropenem will continue until 24 hours after the patient's fever has resolved, after which the treatment will switch to oral azithromycin.
In the intervention group, patients begin with azithromycin 1g administered intravenously for the initial dose, followed by a daily dose of 500mg intravenously. When the patient's condition stabilizes, the treatment will transition to oral azithromycin, starting with a 1g oral dose and continuing with 500mg orally once daily. Intravenous azithromycin will be maintained until 24 hours after the patient's fever has resolved, after which the treatment will switch to oral azithromycin.
76 studies on the registry are indexed under Typhoid Fever; 11 are open to participants now.
This study's planned enrollment of 40 is below the median of 147 across 65 interventional studies indexed under Typhoid Fever.
Browse Typhoid Fever studies →Indus Hospital and Health Network is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants will enrolled on following criteria
Exclusion Criteria:
Participants will excluded on following 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.
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 recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For the standard care protocol, patients are initially treated with meropenem 1g intravenously every 8 hours. Once their condition stabilizes , treatment is transitioned to oral azithromycin. The transition involves administering a first dose of azithromycin 1g orally, followed by a daily dose of 500mg orally. Intravenous meropenem will continue until 24 hours after the patient's fever has resolved, after which the treatment will switch to oral azithromycin.
Drug: Meropenem Injection
In the intervention group, patients begin with azithromycin 1g administered intravenously for the initial dose, followed by a daily dose of 500mg intravenously. When the patient's condition stabilizes, the treatment will transition to oral azithromycin, starting with a 1g oral dose and continuing with 500mg orally once daily. Intravenous azithromycin will be maintained until 24 hours after the patient's fever has resolved, after which the treatment will switch to oral azithromycin
Drug: Azithromycin
Azithromycin 1g IV loading dose then 500mg IV OD
Also known as: Experimental group
Meropenem 1000 mg IV Q8H
Fever defervescence
Proportion of participants with fever defervescence of temperature 37 ℃ at Mid-treatment outcome (Day 7). Temperature will be monitored and documented in degrees centigrade (°C)
Time frame: Mid-treatment outcome (Day 7)
Salmonella Typhi eradication
Proportion of participants with Salmonella Typhi eradication in Blood culture test on day 3. After start of intervention, a clearance of blood culture will be monitor at day 3. if Salmonella Typhi in blood culture of day 3 will not eradicate, a second blood culture will be done on Day 7.
Time frame: Mid-treatment outcome (Day 7)
Hospital Admission Days
Mean hospital length of stay (in days) will be compared between groups to evaluate differences in duration of hospitalization
Time frame: End-of-treatment outcome (Day 14)
Cumulative Treatment Duration
Average total treatment duration, expressed in number of days, will be compared across groups to assess differences in cumulative therapy requirements
Time frame: End-of-treatment outcome (Day 14)
Adverse Events Monitoring
Adverse events will be monitored throughout the study period, including abnormal clinical findings such as rash, pruritus, flushing, or angioedema of the face or extremities. Laboratory assessments (ECG and liver function tests) will be performed on Mid-treatment outcome (Day 7) to check any ECG changes and hepatotoxicity. Vital signs-including body temperature (°C), blood pressure (mmHg), and heart rate (beats/min) will be recorded daily from baseline (Day 1) to day of discharge from hospital.
Time frame: Mid-treatment outcome (Day 7)
Antimicrobial Resistance and Cost of treatment
Antimicrobial resistance will be assessed by monitoring any changes in the susceptibility pattern of Salmonella Typhi isolates during the study period. The direct cost of treatment will be calculated in Pakistani Rupees (PKR), based on the total cost of vials utilized throughout the treatment course, and will be compared between study groups to evaluate overall cost-effectiveness.
Time frame: End-of-treatment outcome (Day 14)
Plan to share: No — will be shared till December 2025
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Jan 2027, 20 months after the start.
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Studies of the drug tested here: Azithromycin
Indus Hospital and Health Network