NCT02453308

A Study by the Tracking Resistance to Artemisinin Collaboration (TRAC)

A Multi-centre, Open-label Randomised Trial to Assess the Efficacy, Safety and Tolerability of Triple Artemisinin-based Combination Therapies (TACTs) Com-pared to Artemisinin-based Combination Therapies (ACTs) in Uncomplicated Falciparum Malaria and to Map the Geographical Spread of Artemisinin and Partner Drug Resistance

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,110 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 6 Months – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label randomised trial comparing standard ACT treatment with matching triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1 site in Africa. There are 2 arm study groups that have 2 treatment arms each. Study group A: A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days. Study group B: B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days. Study group C: C.1: Artesunate-mefloquine for 3 days versus: C.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days. According to the WHO guideline, all patients except for children under the age of 1 year or a weight below 10 kilograms will also be treated with a single dose of low dose primaquine.

Detailed description

In Laos, Myanmar, Bangladesh, India and DRC, the following two combinations will be used: 1. Artemether-lumefantrine combined with amodiaquine (TACT arm) or 2. Artemether-lumefantrine (ACT arm) In Myanmar and Vietnam the following two combinations will be used: 1. Dihydroartemisinin-piperaquine combined with mefloquine (TACT arm) or 2. Dihydroartemisinin-piperaquine (ACT arm) In Cambodia and Thailand the following two combinations will be used: 1. Dihydroartemisinin-piperaquine plus Mefloquine hydrochloride (TACT arm) or 2. Artesunate-mefloquine (ACT arm)

Conditions

• Malaria, Falciparum

Interventions

Type	Name	Description
DRUG	ACT	1. Artemether-lumefantrine for 3 days 2. Dihydroartemisinin-piperaquine for 3 days. 3. Artesunate-mefloquine for 3 days
DRUG	TACT	1. Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days. 2. Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days. 3. Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2015-05-25
• Last updated: 2018-05-09

Locations

20 sites across 8 countries: Bangladesh, Burma, Cambodia, Democratic Republic of the Congo, India, Laos, Thailand, Vietnam