Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas - a Randomized Controlled Trial

19-3288

This study is designed as a multi-centre randomized, open label trial to compare the safety and efficacy of a high dose primaquine (PQ) treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.

2019-08-18

2022-05-14

2022-07-30

Completed

Early phase I

500

Inclusion Criteria: * P. falciparum mono-infection * Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours * Age \>1 years (≥ 18 years at the Ethiopia site) * G6PD normal as defined by the Biosensor (SD Biosensor, ROK) at ≥70% of the adjusted male median (AMM) for each site * Written informed consent * Able to comply with all study procedures and timelines Exclusion Criteria: * General danger signs or symptoms of severe malaria * Anaemia, defined as Hb \<8g/dl * Pregnant women as determined by Urine β-HCG pregnancy test * Breast feeding women * Known hypersensitivity to any of the drugs given * Regular use of drugs with haemolytic potential * Blood transfusion within the last 4 months

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 500, 'type': 'ACTUAL'}}

2023-11-21