A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combinations of 2 Anti-malarial Drugs (Asia)
DeTACT-ASIA
A Multi-centre Randomised Controlled Non-inferiority Trial to Compare the Efficacy, Safety and Tolerability of Triple Artemisinin-based Combination Therapies Versus First-line ACTs + Placebo for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Asia
1 other identifier
interventional
103
2 countries
3
Brief Summary
A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine + amodiaquine (AL+AQ) and artesunate- mefloquine+piperaquine (AS-MQ+PPQ) with the ACTs artemether-lumefantrine + placebo (AL+PBO) and artesunate- mefloquine + placebo (AS-MQ+PBO) (with single-low dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria to assess and compare their efficacy, safety, tolerability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2023
CompletedMarch 20, 2024
May 1, 2023
1.5 years
April 29, 2019
March 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR).
42 days
Secondary Outcomes (17)
Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR)
63-day
Efficacy defined as adequate clinical and parasitological response (PCR)
63-day
Efficacy defined as adequate clinical and parasitological response (ACPR)
42-day
Parasite clearance half-life
7 days
proportion of subjects with microscopically detectable P. falciparum parasitaemia
3 days
- +12 more secondary outcomes
Other Outcomes (15)
Comparison of efficacy, defined as PCR corrected adequate clinical and parasitological response (ACPR) at day 42 versus day 63
63 days
Comparison of efficacy, defined as adequate clinical and parasitological response (ACPR) at day 42 versus day 63
63 days
Proportions of recurrent infections with parasites carrying mutations of known functional significance
63 days
- +12 more other outcomes
Study Arms (4)
Artemether-lumefantrine+amodiaquine (AL+AQ)
ACTIVE COMPARATORTriple ACTs
Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)
ACTIVE COMPARATORTriple ACTs
artemether-lumefantrine+placebo (AL+PBO)
ACTIVE COMPARATORACTs
Artesunate-mefloquine+placebo (AS-MQ+PBO)
ACTIVE COMPARATORACTs.
Interventions
AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children. The dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg/kg and lumefantrine 29-144 mg/kg over 3 days. AQ: Amodiaquine is available as dispersible tablets of 40 mg. The weight-based treatment schedule aims for a dosage of approximately 10mg (4.5-15mg)/kg/day amodiaquine for three days.
AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children. The dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg/kg and lumefantrine 29-144 mg/kg over 3 days. PBO: Placebo tablets for amodiaquine are identical in size, shape and color to the amodiaquine tablets.
AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg/kg/day. MQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg/kg/day. PPQ: Piperaquine will be administered according to an optimised dosing schedule using tablets of 160 or 500 mg of piperaquine tetraphosphate. The weight-based treatment aims for a dosage of approximately * 24 mg/kg/day in patients \<25 kg (range 16.0 - 32.0 mg/kg) piperaquine for three days, thereby approaching the WHO-recommended target range of 20 - 32 mg/kg per day. * 18 mg/kg/day in patients ≥25 kg (range 15.0 - 29.4 mg/kg) piperaquine for three days, thereby approaching the WHO-recommended target range of 16 - 27 mg/kg per day.
AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg/kg/day. MQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg/kg/day. PBO: Placebo tablets for piperaquine are identical in size, shape and colour to the piperaquine tablets.
Eligibility Criteria
You may qualify if:
- Male or female, \>/= 6 months
- Ability to take oral medication
- Acute uncomplicated P. falciparum monoinfection
- Asexual P. falciparum parasitaemia: 96 to 200,000/µL, determined on a peripheral blood film
- Fever defined as \>/= 37.5°C tympanic temperature or a history of fever within the last 24 hours
- Written informed consent by the subject or parent/guardian in case of children lower than the age of consent and assent if required (per local regulations)
- Willingness and ability of the subjects or parents/guardians to comply with the study protocol for the duration of the study
You may not qualify if:
- Signs of severe malaria (adapted from WHO criteria)
- Patients not fulfilling criteria for severe malaria but with another indication for parenteral antimalarial treatment at the discretion of the treating physician
- Haematocrit \< 20% at screening
- Subjects who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days OR mefloquine or piperaquine within the previous 30 days
- Acute illness other than malaria requiring systemic treatment
- Severe acute malnutrition
- Known HIV infection
- Known tuberculosis infection
- For females: pregnant, trying to get pregnant or are lactating
- History of allergy or known contraindication to any of the study drugs, including neuropsychiatric disorders and epilepsy
- Previous splenectomy
- Enrolment in DeTACT in the previous 3 months
- Participation in another interventional study in the previous 3 months
- Criteria for severe malaria
- Impaired consciousness (Glasgow Coma Scale, Blantyre Coma Scale)
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Ramu Upazilla Health Complex
Cox’s Bāzār, Chittagong, Bangladesh
Kravanh Referral Hospital
Phnum Kravanh, Pursat, 150501, Cambodia
Siem Pang Health Center
Siem Pang, Stung Treng, 1803, Cambodia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2019
First Posted
May 6, 2019
Study Start
June 30, 2021
Primary Completion
January 6, 2023
Study Completion
January 28, 2023
Last Updated
March 20, 2024
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After completion of trial activities and reporting
- Access Criteria
- MORU Data Sharing Policy: https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing WWARN terms of Data Access: http://www.wwarn.org/tools-resources/terms-reshouces/terms-data-access
With participant's consent, participant's data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with data repositories such as the WorldWide Antimalarial Resistance Network (WWARN, terms of submission here: http://www.wwarn.org/tools-resources/terms-submission) or other researchers to use in the future. All personal information will be anonymised so that no individual can be identified from their treatment records, through interviews, or from mapping data.