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