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Compares treatment options for Enteric Fever
Official title Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever
ClinicalTrials.gov ID: NCT07314281
What this study is testing
What is Azithromycin?
Azithromycin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for enteric fever.
Also referred to as Experimental group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 1. Primary Objective: o To evaluate the efficacy of intravenous azithromycin compared with meropenem in the treatment of extensively drug-resistant (XDR) enteric fever.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 70
You may be able to join if
- 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.
- No history of cardiac issues with ECG abnormalities, cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use.
You likely can't join if
- 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...
- Patients with history of cardiac disorder with ECG abnormalities and history of cholestatic jaundice/hepatic dysfunction associated with prior...
- Patients on continuous medication, having drug-drug interaction with meropenem and azithromycin will be excluded.
See the full eligibility criteria
- 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.
- No history of cardiac issues with ECG abnormalities, cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use.
- Patients having no hypersensitivity (skin rashes, anaphylaxis) to azithromycin and meropenem
- Patients on concomitant medication, having no drug-drug interaction with meropenem and azithromycin will be included in study.
- 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
- Patients with history of cardiac disorder with ECG abnormalities and history of cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use will be excluded.
- Patients on continuous medication, having drug-drug interaction with meropenem and azithromycin will be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Karachi, Sindh, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Karachi, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.