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

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Treatments: Artemether; Artemether-lumefantrine combination; Artemisinine; Artemisinins; Dihydroartemisinin; Lumefantrine; Mefloquine; Piperaquine

Criteria

Inclusion Criteria:

• Male or female, aged from 6 months to 65 years old

• Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum (or mixed with non-falciparum species)

• Asexual P. falciparum parasitaemia: 5,000 to 200,000/uL, de-termined on a thin or thick blood film (In Cambodia patients with a parasitaemia of 16 to 200,000/uL are eligible. In DRC patients with a parasitaemia of 10,000 to 250,000/ul are eligi-ble)

• Fever defined as >/= 37.5°C tympanic temperature or a history of fever within the last 24 hours

• Written informed consent (by parent/guardian in case of children)

• Willingness and ability of the patients or parents/guardians to comply with the study protocol for the duration of the study

Exclusion Criteria:

• Signs of severe/complicated malaria

• Haematocrit < 25% or Hb < 5 g/dL at screening (DRC: Hct<15% and Hb <5 g/dL due to high prevalence of anemia).

• Acute illness other than malaria requiring treatment

• For females: pregnancy, breast feeding

• Patients who have received artemisinin or a derivative or an artemisinin containing combination therapy (ACT) within the previous 7 days

• Treatment with mefloquine in the 2 months prior to presentation will be an exclusion criteria in the DHA-P+MQ sites

• History of allergy or known contraindication to artemisinins, or to the ACT or TACT to be used at the site e.g. neuropsychiatric disorders will be a contraindication for the use of mefloquine.

• Previous splenectomy

• QTc-interval > 450 milliseconds at moment of presentation

• Documented or claimed history of cardiac conduction problems

• Earlier participation within the TRACII trial or another trial in the previous 3 months.