TY - JOUR
T1 - 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
AU - Ahmad, Sundus Shafat
AU - Verma, Reena
AU - Commons, Robert J.
AU - Nitika,
AU - Singh-Phulgenda, Sauman
AU - Chhajed, Rutuja
AU - Bharti, Praveen K.
AU - Behera, Beauty
AU - Naser, Syed Mohammad
AU - Pal, Salil Kumar
AU - Ranjit, Parinita Halder
AU - Baharia, Rajendra Kumar
AU - Solanki, Bhavin
AU - Upadhyay, K. J.
AU - Guerin, Philippe J.
AU - Sharma, Amit
AU - Price, Ric N.
AU - Rahi, Manju
AU - Thriemer, Kamala
N1 - Funding Information:
Infectious Diseases Data Observatory, University of Oxford, New Richards Building, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LG, UK through a grant from the Bill and Melinda Gates Foundation to PJG (grant number: INV-004713). The funders had no role in the design or conduct of the study.
Publisher Copyright:
© The Author(s) 2024.
PY - 2024/12
Y1 - 2024/12
N2 - 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.
AB - 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.
KW - Malaria elimination, Randomised controlled trial
KW - P. vivax
KW - Primaquine
KW - Radical cure
KW - Vivax malaria
UR - http://www.scopus.com/inward/record.url?scp=85186374851&partnerID=8YFLogxK
U2 - 10.1186/s13063-024-07987-0
DO - 10.1186/s13063-024-07987-0
M3 - Article
C2 - 38424577
AN - SCOPUS:85186374851
SN - 1745-6215
VL - 25
SP - 1
EP - 14
JO - Trials
JF - Trials
IS - 1
M1 - 154
ER -
