Nepal Undifferentiated Febrile Illness Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT02773407
• Date of registration: 05/05/2016
• Prospective Registration: Yes
• Primary sponsor: Oxford University Clinical Research Unit, Vietnam
• Public title: Nepal Undifferentiated Febrile Illness Trial NUFIT
• Scientific title: Parallel Group, Double Blinded, 1:1, Randomized Controlled Phase III Trial of Co-trimoxazole Versus Azithromycin for the Treatment of Undifferentiated Fever In Nepal
• Date of first enrolment: May 23, 2016
• Target sample size: 330
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02773407
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Nepal

Contacts

• Name: Buddha Basnyat, MBBS,MSc,MD
• Affiliation: University of Oxford

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Undifferentiated Febrile Illness

Intervention(s)

Drug: Azithromycin

Drug: Co-trimoxazole

Primary Outcome(s)

Fever clearance time [Time Frame: at least 2 days]

Secondary Outcome(s)

The development of any complication [Time Frame: within 28 days of initiation of treatment]

Fever failure [Time Frame: over 7 days post treatment initiation]

Adverse events [Time Frame: within 63 days]

Need rescue treatment [Time Frame: within 63 days]

Relapse [Time Frame: within 28 days of initiation of treatment]

Time-to-treatment failure [Time Frame: within 63 days]

Microbiological failure [Time Frame: on day 7 of treatment]

Secondary ID(s)

18NP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Wellcome Trust

University of Oxford