NCT03814616

Pyramax in Asymptomatic Carriers of P. Falciparum Monoinfections

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Shin Poong Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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. .

Detailed 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.

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
DRUG	Pyronaridine tetraphosphate 180mg:artesunate 60mg	ACT

Timeline

• Start date: 2018-10-03
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2019-01-24
• Last updated: 2019-09-30

Locations

2 sites across 2 countries: The Gambia, Zambia