Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

Phase 3

Completed

• Conditions: Vivax Malaria; Plasmodium Vivax; Malaria, Vivax; Malaria Relapse
• Interventions: Drug: Primaquine; Drug: Tafenoquine

• Registration Number: NCT04411836
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Health care facility based, randomized, controlled, open label, superiority trial with 3 arms

Detailed Description

* To assess the effectiveness of a short-course of high dose primaquine (total dose 7mg/kg given unsupervised over 7 days) compared to the current standard low dose primaquine regimen (total dose 3.5mg/kg given unsupervised over 14 days).

* To assess the effectiveness of tafenoquine (single dose of 300mg) compared to the short-course high dose primaquine regimen.

* To assess the safety of tafenoquine compared to the high and low dose primaquine regimens.

* To assess the cost-effectiveness and feasibility of high dose primaquine and tafenoquine compared to the current low dose primaquine regimen

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-02
• Study Start: 2021-04-25
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

Not provided

Exclusion Criteria

• Danger signs or symptoms of severe malaria
• Anaemia (defined as Hb <8g/dl)
• Pregnant or lactating females
• Known hypersensitivity to any of the study drugs
• Regular use of drugs with haemolytic potential

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PQ Intervention	Primaquine	Patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)
TQ Intervention	Tafenoquine	Patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ)

Primary Outcome Measures

Name	Time	Method
Incidence risk any P vivax PQ7 / PQ14	6 months	The incidence risk (time to first event) of any P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14).

Secondary Outcome Measures

Name	Time	Method
Incidence risk any P vivax PQ14 / TQ	6 months	The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ14 and TQ arms
Incidence risk any P vivax PQ7 / TQ	6 months	• The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ7 and TQ arms
Incidence risk symptomatic P vivax TQ / PQ14	6 months	The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between TQ and the control arm (PQ14).
Incidence risk any P vivax PQ7 / PQ14	6 months	The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14).

Trial Locations

Locations (6)

Aga Khan Hospital Karachi; 🇵🇰 Karachi, Pakistan

Kravanh District Hospital; 🇰🇭 Pursat, Pursat Province, Cambodia

Siem Pang Health Centre; 🇰🇭 Stung Treng, Cambodia

Arba Minch General Hospital; 🇪🇹 Arba Minch, Ethiopia

Chambak Health Center; 🇰🇭 Kampong Speu, Cambodia

Tanjung Leidong Health Center; 🇮🇩 Labuhanbatu, Sumatera, Indonesia