Ignite Creation Date:
2024-05-06 @ 4:06 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02453308
Status:
COMPLETED
Last Update Posted:
2018-05-09
First Post:
2015-04-20
Brief Title:
A Study by the Tracking Resistance to Artemisinin Collaboration TRAC
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
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
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRACII
Brief 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
A1 Artemether-lumefantrine for 3 days versus A2 Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days
Study group B
B1 Dihydroartemisinin-piperaquine for 3 days versus B2 Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days
Study group C
C1 Artesunate-mefloquine for 3 days versus C2 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
Study group A
A1 Artemether-lumefantrine for 3 days versus A2 Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days
Study group B
B1 Dihydroartemisinin-piperaquine for 3 days versus B2 Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days
Study group C
C1 Artesunate-mefloquine for 3 days versus C2 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None