Overview

Nepal Undifferentiated Febrile Illness Trial

Status:
Unknown status
Trial end date:
2020-08-04
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to determine whether azithromycin or cotrimoxazole is the best empirical treatment for undifferentiated febrile illness in Nepal
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Oxford University Clinical Research Unit, Vietnam
Collaborators:
University of Oxford
Wellcome Trust
Treatments:
Azithromycin
Trimethoprim, Sulfamethoxazole Drug Combination
Criteria
Inclusion Criteria:

- Fever of ≥ 38.0°C and for ≥4 days without a focus of infection

- ≥ 2 years and <65 years of age

- Able to take tablets orally

- Patient residing in Kathmandu Valley

- Able to come for follow up

- Can be reached by telephone/mobile phone 24 hours a day.

- Written informed consent to participate in the study including assent for minors in
addition to parental consent.

Exclusion Criteria:

- Fever >14 days

- Pregnancy

- Obtundation

- Shock

- Visible jaundice

- Presence of signs of gastrointestinal bleeding

- History of hypersensitivity to either of the trial drugs

- Patient requiring intravenous antibiotic or hospital admission for any reason.

- Contraindication of drug for any reason (e.g. drug interactions).

- Any patient fulfilling inclusion criteria but already on antimicrobials and responding
clinically to the treatment