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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04411836
Other study ID # EFFORT
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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