ACT vs CQ With Tafenoquine for P. Vivax Mono-infection

Phase 4

Recruiting

• Conditions: Malaria; Malaria, Vivax; Plasmodium Vivax Malaria

• Registration Number: NCT05788094
• Lead Sponsor: Shoklo Malaria Research Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-1-9
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 606

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients with P. vivax mono-infection as diagnosed by Rapid Diagnostic Test<br><br> - Fever or history of fever in the previous 7 days<br><br> - Quantitative G6PD activity =70% of the population median i.e., =6.1U/gHb<br><br> - Age > 18 years, Weight >35 kg<br><br> - Ability to understand the study instructions and provide informed consent<br><br> - Willing to be followed for 4 months and likely to adhere to the study protocol.<br><br>Exclusion Criteria:<br><br> - Coincident P. falciparum malaria or other infections<br><br> - Pregnancy<br><br> - Lactation<br><br> - Hb < 8 g/dL<br><br> - Quantitative G6PD activity <70% of the population median i.e., <6.1U/gHb<br><br> - Severe malaria (as per WHO guideline)<br><br> - History of allergic or haemolytic response to any of the study drugs

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine whether ACTs (Artemether-Lumefantrine or dihydroartemisinin-piperaquine (DHA-PPQ)) plus TQ is non-inferior to CQ plus TQ

Secondary Outcome Measures

Name	Time	Method
Characterise the safety and tolerability of three regimens;Characterise population pharmacokinetics of tafenoquine in three treatments;Met-Haemoglobin level a vivo pharmacodynamic proxy of oxidative antimalarial activity of tafenoquine