Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

Malaria, Vivax Clinical Trial

— EFFORT  

Official title:

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine - a Randomized Controlled Trial in P. Vivax Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04411836
• Other study ID #: EFFORT
• Status: Recruiting
• Phase: Phase 3
• Start date: April 25, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Menzies School of Health Research
• Contact: Kamala Thriemer, MD, MPH, PhD
• Phone: 0889468644
• Email: kamala.ley-thriemer[@]menzies.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria

• P. vivax peripheral parasitaemia (mono-infection) as determined by microscopy

• G6PD normal status (G6PD activity = 70% of the adjusted male median as determined by the Biosensor™ (SD Biosensor, ROK))

• Fever (temperature =37.5°C) or history of fever in the preceding 48 hours

• Age =18 years

• Written informed consent

• Living in the study area and willing to be followed for six months

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

Related Conditions & MeSH terms

• Malaria
• Malaria Relapse
• Malaria, Vivax
• Plasmodium Vivax
• Vivax Malaria

Intervention

Drug:
• Tafenoquine
patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ).
• Primaquine
patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)

Locations

Country	Name	City	State
Cambodia	Chambak Health Center	Kampong Speu
Cambodia	Kravanh District Hospital	Pursat	Pursat Province
Cambodia	Siem Pang Health Centre	Stung Treng
Ethiopia	Arba Minch General Hospital	Arba Minch
Indonesia	Tanjung Leidong Health Center	Labuhanbatu	Sumatera
Pakistan	Aga Khan Hospital Karachi	Karachi

Sponsors (8)

Lead Sponsor	Collaborator
Menzies School of Health Research	Aga Khan University, Arba Minch University, Ethiopian Public Health Institute, Mahidol Oxford Tropical Medicine Research Unit, National Centre for Parasitology, Entomology and Malaria Control, Cambodia, Universitas Sumatera Utara, University of Melbourne

Countries where clinical trial is conducted

Cambodia,  Ethiopia,  Indonesia,  Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence risk any P vivax PQ7 / PQ14	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).	6 months
Secondary	Incidence risk any P vivax PQ7 / TQ	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	6 months
Secondary	Incidence risk symptomatic P vivax TQ / PQ14	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).	6 months
Secondary	Incidence risk any P vivax PQ7 / PQ14	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).	6 months
Secondary	Incidence risk any P vivax PQ7 / TQ	• 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	6 months
Secondary	Incidence risk any P vivax PQ14 / TQ	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	6 months