Nepal Undifferentiated Febrile Illness Trial (NUFIT)
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| ClinicalTrials.gov Identifier: NCT02773407 |
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Recruitment Status : Unknown
Verified April 2018 by Oxford University Clinical Research Unit, Vietnam.
Recruitment status was: Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : August 30, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Undifferentiated Febrile Illness | Drug: Azithromycin Drug: Co-trimoxazole | Phase 3 |
Fever is one of the most common presenting symptoms of patients presenting to health centers in Nepal. Many of the times, it is difficult to diagnose the cause of the fever by initial history, clinical examination and basic laboratory tests and the patents are treated as presumed enteric fever or fever without focus needing antimicrobials. In fact there are various causes of similarly presenting febrile illnesses including typhoid, paratyphoid, murine typhus, scrub typhus etc.
Many of the traditionally used drugs including fluoroquinolones are now resistant against enteric fever in south asia. Oral azithromycin is now commonly used to treat undifferentiated febrile illness and remains effective against enteric fever. Many physicians now also use co-trimoxazole as it was very commonly used in the treatment of enteric fever in the past. Resistance to co-trimoxazole emerged two decades ago, but has subsequently largely disappeared and nearly all Salmonella Typhi and Paratyphi A strains from Nepal are now susceptible. Anecdotal reports claim that it seems to work very well against undifferentiated febrile illness in Nepal; it is largely stocked in government health facilities and is a popular and cheap treatment option.
Both azithromycin and co-trimoxazole are available in Nepal and are extensively used in the treatment of undifferentiated febrile illness. Therefore it is important to know the better oral option to treat enteric fever and other febrile illnesses and also to have an alternative oral treatment in case resistance to azithromycin emerges.
The investigators purpose to conduct a head to head, parallel group, 1:1, double blinded randomized controlled trial to compare azithromycin and co-trimoxazole for the treatment of undifferentiated febrile illness and determine the best empirical treatment for undifferentiated febrile illness in Nepal.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 330 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | May 23, 2016 |
| Actual Primary Completion Date : | August 4, 2019 |
| Estimated Study Completion Date : | August 4, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Group A
Azithromycin tablets 20mg/kg/day for 7 days (Maximum dose 1000mg/day)
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Drug: Azithromycin |
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Active Comparator: Group B
Co-trimoxazole tablets (Trimethoprim 10 mg/kg+Sulphamethoxazole 50 mg/kg) in two divided doses everyday for 7 days (maximum 3000mg/day)
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Drug: Co-trimoxazole |
- Fever clearance time [ Time Frame: at least 2 days ]time from the first dose of a study drug until a temperature ≤37.5°C for at least 2 days
- Fever failure [ Time Frame: over 7 days post treatment initiation ]defined by fever clearance time (FCT) >7 days post treatment initiation;
- Need rescue treatment [ Time Frame: within 63 days ]Requirement for rescue treatment as judged by the Research Medical Officer (RMO) and Attending Physician (AP)
- Microbiological failure [ Time Frame: on day 7 of treatment ]Blood culture positivity for S. Typhi or an S. Paratyphi
- Relapse [ Time Frame: within 28 days of initiation of treatment ]Culture-confirmed or syndromic enteric fever relapse
- The development of any complication [ Time Frame: within 28 days of initiation of treatment ]any complication: e.g. clinically significant bleeding, fall in the Glasgow Coma Score, perforation of the gastrointestinal tract and hospital admission
- Time-to-treatment failure [ Time Frame: within 63 days ]the time from the first dose of treatment until the date of the earliest failure event
- Adverse events [ Time Frame: within 63 days ]grade 3/4 adverse events, serious adverse events, adverse events of any grade leading to modification of study drug dose or interruption/early discontinuation
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| Ages Eligible for Study: | 2 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773407
| Nepal | |
| Nepal Civil Service Hospital | |
| Kathmandu, Nepal | |
| Patan Hospital | |
| Kathmandu, Nepal | |
| Principal Investigator: | Buddha Basnyat, MBBS,MSc,MD | University of Oxford |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Oxford University Clinical Research Unit, Vietnam |
| ClinicalTrials.gov Identifier: | NCT02773407 |
| Other Study ID Numbers: |
18NP |
| First Posted: | May 16, 2016 Key Record Dates |
| Last Update Posted: | August 30, 2019 |
| Last Verified: | April 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Anonymised individual participant data will be made available to researcher and public as a supporting material via open access journal and/or upon request by qualified research groups |
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Undifferentiated febrile illness Azithromycin Cotrimoxazole |
Efficacy Enteric fever Fever clearance time |
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Hyperthermia Fever Body Temperature Changes Heat Stress Disorders Wounds and Injuries Azithromycin Trimethoprim, Sulfamethoxazole Drug Combination |
Anti-Bacterial Agents Anti-Infective Agents Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |