Pyramax in Asymptomatic Carriers of P. Falciparum Monoinfections

Malaria,Falciparum Clinical Trial

Official title: A Randomized, Open-Label Exploratory Study To Determine The Efficacy Of Different Treatment Regimens Of Pyramax® (Pyronaridine-Artesunate) In Asymptomatic Carriers Of Plasmodium Falciparum Monoinfections

Status Active, not recruiting

Clinical Trial Summary

This study will assess the efficacy of Pyramax administered for three-day, two-day or one day, in clearing a P. falciparum infection in asymptomatic carriers.

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Clinical Trial Description

This is a randomized, open-label, three-arm, out-patient study in asymptomatic individuals with P. falciparum monoinfection confirmed at baseline, who are >5 years of age and >20kg body weight. A total of 300 participants will be randomised into the study; 100 participants in each of three treatment arms.

Patients who fulfil the entry criteria (all inclusion and none of the exclusion criteria) will be recruited and randomized to receive Pyramax orally for three days, two days or one day in a randomization ratio of 1:1:1.

All participants will be followed until Day 63 (counted from day 0) and blood samples will be taken on Days 0, 1, 2, 3, 7, 14, 21, 28, 35, 42 and 63 for malaria diagnostics, parasite density and qPCR. In addition, blood samples reverse-transcriptase (RT)-PCR will be taken on Days 0, 1, 2, 3, 7 and 14.

Participants will be administered local SOC treatment if they meet any of the protocol-specific criteria of treatment failure: Early treatment failure, Late clinical failure, or Late parasitological failure up to and including Day 63, or if the participant withdraws at any time before Day 63, and is parasite positive. ;

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Malaria,Falciparum

• NCT number: NCT03814616
• Study type: Interventional
• Source: Shin Poong Pharmaceutical Co. Ltd.
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 3, 2018
• Completion date: October 2019