A Study by the Tracking Resistance to Artemisinin Collaboration (TRAC)
NCT ID: NCT02453308
Last Updated: 2018-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
1110 participants
INTERVENTIONAL
2015-08-31
2018-03-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ACT-arms
1.1 Artemether-lumefantrine for 3 days.
1.2 Dihydroartemisinin-piperaquine for 3 days
1.3 Artesunate-Mefloquine for 3 days
ACT
1. Artemether-lumefantrine for 3 days
2. Dihydroartemisinin-piperaquine for 3 days.
3. Artesunate-mefloquine for 3 days
TACT-arms
2.1: Artemether-lumefantrine for 3 days.plus: Amodiaquine for 3 days.
2.2: Dihydroartemisinin-piperaquine for 3 days. plus: Mefloquine hydrochloride for 3 days.
2.3 Dihydroartemisinin-piperaquine for 3 days. plus: Mefloquine hydrochloride for 3 days.
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.
Interventions
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ACT
1. Artemether-lumefantrine for 3 days
2. Dihydroartemisinin-piperaquine for 3 days.
3. Artesunate-mefloquine for 3 days
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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.
6 Months
65 Years
ALL
No
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Arjen Dondorp, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol Oxford Tropical Medicine Research Unit
Locations
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College of Medicine Chittagong
Rāmu, , Bangladesh
Ann Hospital
Ann Town, , Burma
Pyay hospital
Prome, , Burma
Pyin oo Lwin hospital
Pyin Oo Lwin, , Burma
Thabeikkyin hospital
Thabeikkyin, , Burma
Pailin
Pailin, , Cambodia
Preah Vihear
Preah Vihear, , Cambodia
Pursat
Pursat, , Cambodia
Ratanakiri
Ratankiri, , Cambodia
Kinshasa
Kinshasa, , Democratic Republic of the Congo
Ispat General hospital
Rourkela, Rourkela, India
Mohanpur Community health center
Agartala, , India
Midnapore
Medinīpur, , India
Sekong
Sekong, , Laos
Phusing hospital
Phusing, Changwat Si Sa Ket, Thailand
Tha Song Yang hospital
Tha Song Yang, Changwat Tak, Thailand
Chumphon hospital
Chumphon, , Thailand
Kunhan Hospital
Si Sa Ket, , Thailand
Thanto Hospital
Yala, , Thailand
Binh Phuoc hospital
Bình Phước, , Vietnam
Countries
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References
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van der Pluijm RW, Tripura R, Hoglund RM, Pyae Phyo A, Lek D, Ul Islam A, Anvikar AR, Satpathi P, Satpathi S, Behera PK, Tripura A, Baidya S, Onyamboko M, Chau NH, Sovann Y, Suon S, Sreng S, Mao S, Oun S, Yen S, Amaratunga C, Chutasmit K, Saelow C, Runcharern R, Kaewmok W, Hoa NT, Thanh NV, Hanboonkunupakarn B, Callery JJ, Mohanty AK, Heaton J, Thant M, Gantait K, Ghosh T, Amato R, Pearson RD, Jacob CG, Goncalves S, Mukaka M, Waithira N, Woodrow CJ, Grobusch MP, van Vugt M, Fairhurst RM, Cheah PY, Peto TJ, von Seidlein L, Dhorda M, Maude RJ, Winterberg M, Thuy-Nhien NT, Kwiatkowski DP, Imwong M, Jittamala P, Lin K, Hlaing TM, Chotivanich K, Huy R, Fanello C, Ashley E, Mayxay M, Newton PN, Hien TT, Valecha N, Smithuis F, Pukrittayakamee S, Faiz A, Miotto O, Tarning J, Day NPJ, White NJ, Dondorp AM; Tracking Resistance to Artemisinin Collaboration. Triple artemisinin-based combination therapies versus artemisinin-based combination therapies for uncomplicated Plasmodium falciparum malaria: a multicentre, open-label, randomised clinical trial. Lancet. 2020 Apr 25;395(10233):1345-1360. doi: 10.1016/S0140-6736(20)30552-3. Epub 2020 Mar 11.
van der Pluijm RW, Imwong M, Chau NH, Hoa NT, Thuy-Nhien NT, Thanh NV, Jittamala P, Hanboonkunupakarn B, Chutasmit K, Saelow C, Runjarern R, Kaewmok W, Tripura R, Peto TJ, Yok S, Suon S, Sreng S, Mao S, Oun S, Yen S, Amaratunga C, Lek D, Huy R, Dhorda M, Chotivanich K, Ashley EA, Mukaka M, Waithira N, Cheah PY, Maude RJ, Amato R, Pearson RD, Goncalves S, Jacob CG, Hamilton WL, Fairhurst RM, Tarning J, Winterberg M, Kwiatkowski DP, Pukrittayakamee S, Hien TT, Day NP, Miotto O, White NJ, Dondorp AM. Determinants of dihydroartemisinin-piperaquine treatment failure in Plasmodium falciparum malaria in Cambodia, Thailand, and Vietnam: a prospective clinical, pharmacological, and genetic study. Lancet Infect Dis. 2019 Sep;19(9):952-961. doi: 10.1016/S1473-3099(19)30391-3. Epub 2019 Jul 22.
Other Identifiers
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BAKMAL1502
Identifier Type: -
Identifier Source: org_study_id
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