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Co-trimoxazole versus azithromycin for the treatment of undifferentiated febrile illness in Nepal: study protocol for a randomized controlled trial.

ABSTRACT: Undifferentiated febrile illness (UFI) includes typhoid and typhus fevers and generally designates fever without any localizing signs. UFI is a great therapeutic challenge in countries like Nepal because of the lack of available point-of-care, rapid diagnostic tests. Often patients are empirically treated as presumed enteric fever. Due to the development of high-level resistance to traditionally used fluoroquinolones against enteric fever, azithromycin is now commonly used to treat enteric fever/UFI. The re-emergence of susceptibility of Salmonella typhi to co-trimoxazole makes it a promising oral treatment for UFIs in general. We present a protocol of a randomized controlled trial of azithromycin versus co-trimoxazole for the treatment of UFI.This is a parallel-group, double-blind, 1:1, randomized controlled trial of co-trimoxazole versus azithromycin for the treatment of UFI in Nepal. Participants will be patients aged 2 to 65 years, presenting with fever without clear focus for at least 4 days, complying with other study criteria and willing to provide written informed consent. Patients will be randomized either to azithromycin 20 mg/kg/day (maximum 1000 mg/day) in a single daily dose and an identical placebo or co-trimoxazole 60 mg/kg/day (maximum 3000 mg/day) in two divided doses for 7 days. Patients will be followed up with twice-daily telephone calls for 7 days or for at least 48 h after they become afebrile, whichever is later; by home visits on days 2 and 4 of treatment; and by hospital visits on days 7, 14, 28 and 63. The endpoints will be fever clearance time, treatment failure, time to treatment failure, and adverse events. The estimated sample size is 330. The primary analysis population will be all the randomized population and subanalysis will be repeated on patients with blood culture-confirmed enteric fever and culture-negative patients.Both azithromycin and co-trimoxazole are available in Nepal and are extensively used in the treatment of UFI. Therefore, it is important to know the better orally administered antimicrobial to treat enteric fever and other UFIs especially against the background of fluoroquinolone-resistant enteric fever.ClinicalTrials.gov, ID: NCT02773407 . Registered on 5 May 2016.

SUBMITTER: Pokharel S

PROVIDER: S-EPMC5625657 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Co-trimoxazole versus azithromycin for the treatment of undifferentiated febrile illness in Nepal: study protocol for a randomized controlled trial.

Pokharel Sunil S Basnyat Buddha B Arjyal Amit A Mahat Saruna Pathak SP Kc Raj Kumar RK Bhuju Abhusani A Poudyal Buddhi B Kestelyn Evelyne E Shrestha Ritu R Phuong Dung Nguyen Thi DNT Thapa Rajkumar R Karki Manan M Dongol Sabina S Karkey Abhilasha A Wolbers Marcel M Baker Stephen S Thwaites Guy G

Trials 20171002 1

<h4>Background</h4>Undifferentiated febrile illness (UFI) includes typhoid and typhus fevers and generally designates fever without any localizing signs. UFI is a great therapeutic challenge in countries like Nepal because of the lack of available point-of-care, rapid diagnostic tests. Often patients are empirically treated as presumed enteric fever. Due to the development of high-level resistance to traditionally used fluoroquinolones against enteric fever, azithromycin is now commonly used to ...[more]

PMID: 28969659

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Project description:ObjectivesScrub typhus is an emerging neglected tropical disease, reported from many parts of Asia including Nepal. This study aims to determine the seroepidemiology of scrub typhus among febrile patients attending Chitwan Medical College Teaching Hospital (CMC-TH), Bharatpur, Nepal.Study design and settingThis was a hospital laboratory-based prospective study conducted in CMC-TH (a 750-bed hospital) located in Bharatpur, Chitwan district of Nepal.ParticipantsA total of 1797 patients visiting CMC-TH with acute febrile illness (temperature more than 38°C) were enrolled in this study.MethodsA total of 1797 blood samples were collected from patients presenting with acute febrile illness. The samples were processed for detection of antibody for scrub typhus by ELISA for specific IgM antibody and Weil-Felix test.ResultsOut of 1797 serum sample of febrile patients, 524 (29.2%) were scrub typhus positive. Maximum seropositive cases were from Chitwan district, 271 (51.7%) with predominance among women, 314 (35.9%). Scrub typhus was common among age group 51-60 years (37.2%) and farmers, 182 (37.8%). Highest seropositivity was found in July, 60 (57.7%). Fever was common clinical symptom. Thrombocytopenia was seen in 386 (73.7%) and raised transaminase aspartate aminotransferase, 399 (76.1%) among seropositive cases. Weil-Felix test positive were 397 (22.1%) and IgM ELISA positive were 524 (29.2%). The correlation between IgM ELISA and Weil-Felix test showed statistically significant association (r=0.319, p<0.001).ConclusionHigh prevalence of scrub typhus implies that patients with acute febrile illness should be investigated for scrub typhus with high priority. There is utmost need of reliable diagnostic facilities at all levels of healthcare system in Nepal. Infection with scrub typhus was found high and this calls for an urgent need to introduce vaccine against scrub typhus. More sustain and vigorous awareness programmes need to be promoted for early diagnosis, treatment and control.

Dataset Information

Co-trimoxazole versus azithromycin for the treatment of undifferentiated febrile illness in Nepal: study protocol for a randomized controlled trial.

Publications

Co-trimoxazole versus azithromycin for the treatment of undifferentiated febrile illness in Nepal: study protocol for a randomized controlled trial.

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