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Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever

ConditionEnteric Fever
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-70
SponsorIndus Hospital and Health Network

About this trial

1. Primary Objective:

o To evaluate the efficacy of intravenous azithromycin compared with meropenem in the treatment of extensively drug-resistant (XDR) enteric fever. 2. Secondary Objectives:

* To evaluate the fever defervescence and Salmonella Typhi eradication * To evaluate the cost-effectiveness of intravenous azithromycin versus meropenem in treating XDR enteric fever. 3. Exploratory Objectives:

* To evaluate the drug resistance against intravenous azithromycin versus in treating XDR enteric fever.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants will enrolled on following criteria

Voluntarily sign the written informed consent

Patient's of age 1-70 years with clinically suspected on physician decision or XDR enteric fever confirmed by blood culture and sensitivity tests.

Married females with negative pregnancy test.

Disqualifiers

Participants will excluded on following criteria

Pregnant, lactating women or women of childbearing age with positive pregnancy test at baseline.

Patients with known hypersensitivity (skin rashes, anaphylaxis) to azithromycin, meropenem, or any other macrolide or carbapenem antibiotics.

Blood culture and sensitivity tests reported positive culture with MDR S. typhi (non-susceptibility to at least one agent in three or more antimicrobial categories,) o

Trial design

Design model

Parallel

Treatments tested in this trial

  • Azithromycin

    Drug

    Azithromycin 1g IV loading dose then 500mg IV OD

  • Meropenem Injection

    Drug

    Meropenem 1000 mg IV Q8H

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Meropenem armActive comparator 1 intervention
Group B: Azithromycin armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

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

Indus Hospital and Health Network

Lead sponsor

Source ClinicalTrials.gov
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