Status:
RECRUITING
The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial)
Lead Sponsor:
Oxford University Clinical Research Unit, Vietnam
Collaborating Sponsors:
University of Oxford
Medical Research Council
Conditions:
Typhoid Fever
Eligibility:
All Genders
2-65 years
Phase:
PHASE4
Brief Summary
Typhoid and paratyphoid (enteric) fever affects more than 11 million children and adults globally each year including 7 million in South Asia. Up to 1% of patients who get typhoid may die of the disea...
Eligibility Criteria
Inclusion
- A history of fever at presentation for ≥ 72 hours and a documented fever (≥37.5oC (axillary) or ≥38oC (oral))
- Age ≥ 2 years (and ≥ 10kg) to 65 years
- No clear focus of infection on initial clinical evaluation
- Malaria rapid Diagnostic test( RDT) negative; dengue nonstructural protein(NS) 1 RDT negative; scrub typhus RDT negative; c-reactive protein(CRP) rapid test ≥10 mg/L
- Able to take oral treatment
- Able to attend for follow-up and can be contacted by telephone
- Written fully informed consent to participate in the study including assent for children in addition to parental/legal guardian consent.
Exclusion
- History of fever for \>14 days
- Pregnant or positive pregnancy test or breast-feeding
- Presence of clinical symptoms or signs indicating a focal infection such as pneumonia; urinary infection, meningitis, eschar
- Obtundation, haemodynamic shock, visible jaundice, gastrointestinal bleeding or any signs of severe disease that may require immediate hospitalisation
- Being treated for TB or HIV or severe acute malnutrition
- Patients with cardiac disease
- Patient requiring intravenous antibiotics for any reason
- Previous history of hypersensitivity to any of the treatment options
- Either of the trial drugs are contraindicated for any reason (e.g. drug interactions)
- Has received azithromycin or cefixime in the last five days
- Receiving another antimicrobial and responding clinically to the treatment as judged by the attending clinician.
Key Trial Info
Start Date :
May 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
2150 Patients enrolled
Trial Details
Trial ID
NCT04349826
Start Date
May 23 2021
End Date
September 30 2025
Last Update
July 22 2025
Active Locations (1)
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1
Patan Hospital
Lalitpur, Bagmati, Nepal