A randomised controlled trial to compare the efficacy, safety, and tolerability of low dose, short course primaquine in adults with uncomplicated P. vivax malaria in two hospitals in India
Issued Date
2024-12-01
Resource Type
eISSN
17456215
Scopus ID
2-s2.0-85186374851
Pubmed ID
38424577
Journal Title
Trials
Volume
25
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Trials Vol.25 No.1 (2024)
Suggested Citation
Ahmad S.S., Verma R., Commons R.J., Nitika, Singh-Phulgenda S., Chhajed R., Bharti P.K., Behera B., Naser S.M., Pal S.K., Ranjit P.H., Baharia R.K., Solanki B., Upadhyay K.J., Guerin P.J., Sharma A., Price R.N., Rahi M., Thriemer K. A randomised controlled trial to compare the efficacy, safety, and tolerability of low dose, short course primaquine in adults with uncomplicated P. vivax malaria in two hospitals in India. Trials Vol.25 No.1 (2024). doi:10.1186/s13063-024-07987-0 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/97576
Title
A randomised controlled trial to compare the efficacy, safety, and tolerability of low dose, short course primaquine in adults with uncomplicated P. vivax malaria in two hospitals in India
Author's Affiliation
Infectious Diseases Data Observatory
Mahidol Oxford Tropical Medicine Research Unit
Academy of Scientific and Innovative Research (AcSIR)
B. J. Medical College, Ahmedabad
Ahmedabad Municipal Corporation
West Bengal University of Health Sciences
International Centre for Genetic Engineering and Biotechnology
Menzies School of Health Research
Indian Council of Medical Research
National Institute of Malaria Research India
Nuffield Department of Medicine
WorldWide Antimalarial Resistance Network
Delhi Skill and Entrepreneurship University
Grampians Health
Mahidol Oxford Tropical Medicine Research Unit
Academy of Scientific and Innovative Research (AcSIR)
B. J. Medical College, Ahmedabad
Ahmedabad Municipal Corporation
West Bengal University of Health Sciences
International Centre for Genetic Engineering and Biotechnology
Menzies School of Health Research
Indian Council of Medical Research
National Institute of Malaria Research India
Nuffield Department of Medicine
WorldWide Antimalarial Resistance Network
Delhi Skill and Entrepreneurship University
Grampians Health
Corresponding Author(s)
Other Contributor(s)
Abstract
Background: Plasmodium vivax remains a major challenge for malaria control and elimination due to its ability to cause relapsing illness. To prevent relapses the Indian National Center for Vector Borne Diseases Control (NCVBDC) recommends treatment with primaquine at a dose of 0.25 mg/kg/day provided over 14 days. Shorter treatment courses may improve adherence and treatment effectiveness. Methods: This is a hospital-based, randomised, controlled, open-label trial in two centres in India. Patients above the age of 16 years, with uncomplicated vivax malaria, G6PD activity of ≥ 30% of the adjusted male median (AMM) and haemoglobin levels ≥ 8 g/dL will be recruited into the study and randomised in a 1:1 ratio to receive standard schizonticidal treatment plus 7-day primaquine at 0.50 mg/kg/day or standard care with schizonticidal treatment plus 14-day primaquine at 0.25 mg/kg/day. Patients will be followed up for 6 months. The primary endpoint is the incidence risk of any P. vivax parasitaemia at 6 months. Safety outcomes include the incidence risk of severe anaemia (haemoglobin < 8 g/dL), the risk of blood transfusion, a > 25% fall in haemoglobin and an acute drop in haemoglobin of > 5 g/dL during primaquine treatment. Discussion: This study will evaluate the efficacy and safety of a 7-day primaquine regimen compared to the standard 14-day regimen in India. Results from this trial are likely to directly inform national treatment guidelines. Trial registration: Trial is registered on CTRI portal, Registration No: CTRI/2022/12/048283.