Plasmodium Falciparum Malaria (Uncomplicated)Phase 3DeTACT-AfricaNCT03923725
A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.
A Phase 3 study testing Artemether-lumefantrine+ Amodiaquine (AL+AQ) and Artesunate-mefloquine+piperaquine (AS-MQ+PPQ) in people with Plasmodium Falciparum Malaria (Uncomplicated), run by University of Oxford at 8 sites in 8 countries.
Trial 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 (ASMQ+PPQ) and the ACTs artemether-lumefantrine+placebo (AL+PBO), artesunate-mefloquine+placebo (ASMQ+PBO)… Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Plasmodium Falciparum Malaria (Uncomplicated)
- What is being tested?
- Artemether-lumefantrine+ Amodiaquine (AL+AQ) and Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,583 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 1 Sep 2020to 15 Mar 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female, aged ≥6 months to <12 years (For Gambia, Rwanda sites only: ≥6 months)
- Ability to take oral medication
- Acute uncomplicated P. falciparum monoinfection
- Asexual P. falciparum parasitaemia: 1,000/µL to ≤10% parasitaemia, determined on a peripheral blood film (At Gambia, Rwanda sites only: For subjects ≥12 years - 1000/µL to 200,000/µL)
- 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 by 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
Who cannot join
- 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 <15% at screening (For Gambia, Rwanda sites only: For subjects ≥12 years - 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
- In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 14 days.
- Acute illness other than malaria requiring systemic treatment
Show all 14Show fewer
- Severe acute malnutrition (in Niger only - only those patients with Severe Acute Malnutrition and complications requiring inpatient nutritional treatment will be excluded)
- Known HIV infection
- Known tuberculosis infection
- For females: post-menarche (For Gambia, Rwanda sites only: females who are 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
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Burkina Faso1 site
Institut des Sciences et Techniques (INSTech)
Bobo-Dioulasso
Democratic Republic of the Congo1 site
Kinshasa School of Public Health
Kinshasa, BP 11850 Kin
Guinea1 site
Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah
Conakry, B.P. 2649
Nigeria1 site
Centre for Malaria and Other Tropical Diseases (CEMTROD)
Ilorin, Kwara State, 1459
Rwanda1 site
College of Medicine and Health Sciences, University of Rwanda
Kigali
Tanzania1 site
National Institute For Medical Research (NIMR), Tanga Medical Research Centre
Tanga
About this study
Official title: 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 Africa
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 (ASMQ+PPQ) and the ACTs artemether-lumefantrine+placebo (AL+PBO), artesunate-mefloquine+placebo (ASMQ+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.
Read the detailed description
Subjects will be randomized to up to four arms: artemether-lumefantrine + amodiaquine, artemether-lumefantrine + placebo, artesunate-mefloquine + piperaquine and artesunate-mefloquine + placebo. As a contingency measure in case of significant differences in the efficacy or safety of one of the combinations being tested and/or study drug expiry or unavailability, subjects may be randomised to 2 arms with a matching ACT-TACT pair, i.e., with artemether-lumefantrine + placebo or artemether-lumefantrine + amodiaquine OR artesunate-mefloquine + placebo or artesunate-mefloquine + piperaquine.
Some sites may randomize between 2 arms only with matching ACT-TACT pairs, i.e., artemether-lumefantrine + placebo or artemether-lumefantrine + amodiaquine OR artesunate-mefloquine + placebo or artesunate-mefloquine + piperaquine. In Rwanda, subjects will be randomized between 2 arms consisting of artemether-lumefantrine + placebo or artemether-lumefantrine + amodiaquine.
In the control arms, the ACT will be co-packed with a matched (appearance) placebo.
In lower transmission settings (Annual Parasite Incidence <50 per 1000 population per year) the treatment will include a single 0.25 mg/kg gametocytocidal dose of primaquine as recommended by the WHO for children ≥10 kg. All drug administrations will be observed.
Subjects will be treated in an in-patient unit for 3 days and followed up weekly up to D63. Microscopy to detect and quantify malaria parasitaemia will be performed daily (more frequently in patients with parasite density of >5000/µL at inclusion) during hospitalization, at all weekly and unscheduled visits. A physical examination and measurements of vital signs along with a symptom questionnaire for tolerability will be performed and recorded through a standardized method at baseline, daily during admission and weekly during follow up through D42 and at all unscheduled visits. Physical exam, vital sign measurements and assessments of symptoms will be performed on D49, D56, and D63 only for patients who are parasitaemic or those who report fever or other symptoms. Electrocardiographs will be performed during admission (H0, H4, H52 or H64) and day 42 of follow up to assess and compare the effect of ACTs and TACTs antimalarials on QT or QTc intervals.
The DeTACT-Africa Trial is funded by UK Aid from the UK government's Foreign, Commonwealth and Development Office.
- Being tested
- Artemether-lumefantrine+ Amodiaquine (AL+AQ), Artemether-lumefantrine + placebo (AL+PBO), Artesunate-mefloquine+piperaquine (AS-MQ+PPQ), Artesunate-mefloquine+placebo (AS-MQ+PBO)
- Keywords
- Artemether, Lumefantrine, Amodiaquine, Artesunate, Piperaquine, Mefloquine, Triple Artemisinin-based Combination Therapy (TACT)
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrine+ Amodiaquine (AL+AQ)Drug
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: 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.
Artemether-lumefantrine + placebo (AL+PBO)Drug
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.
Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)Drug
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.
Artesunate-mefloquine+placebo (AS-MQ+PBO)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Artemether-lumefantrine+amodiaquine (AL+AQ) | Experimental | Triple ACTs Receives: Drug: Artemether-lumefantrine+ Amodiaquine (AL+AQ) |
| artemether-lumefantrine+placebo (AL+PBO) | Active comparator | ACTs Receives: Drug: Artemether-lumefantrine + placebo (AL+PBO) |
| Artesunate-mefloquine+Piperaquine (AS-MQ+PPQ) | Experimental | Triple ACTs Receives: Drug: Artesunate-mefloquine+piperaquine (AS-MQ+PPQ) |
| Artesunate-mefloquine+placebo (AS-MQ+PBO) | Active comparator | ACTs Receives: Drug: Artesunate-mefloquine+placebo (AS-MQ+PBO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
42 days Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR).
42 days Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR).
Measured: 42 days
Secondary outcomes (17)
63-day PCR corrected and uncorrected efficacy
Measured: 63 days
42-day PCR uncorrected efficacy
Measured: 42 days
Parasite clearance half-life
Assessed by microscopy as primary parameter to determine parasite clearance
Measured: 3 Days
Proportion of subjects with microscopically detectable P. falciparum parasitaemia
Measured: Day 3
Fever clearance time
fever clearance time (i.e. the time taken for the tympanic temperature to fall below 37.5 ºC)
Measured: 63 Days
Proportion of subjects with gametocytaemia
proportion of subjects with gametocytaemia during and after treatment stratified by presence of gametocytes at enrolment
Measured: 63 Days
Incidence of adverse events
including markers of hepatic, renal or bone marrow toxicity; cardiotoxicity
Measured: 42 days
Incidence of serious adverse events
including markers of hepatic, renal or bone marrow toxicity; cardiotoxicity
Measured: 42 days
Number of cardiotoxicity events
In particular QT or QTc-interval above 500 ms at timepoint H4 and H52/H64 and between these time points
Measured: 52 or 64 hours depends on treatment arm
Change in haemoglobin stratified for G6PD status/genotype
Measured: 28 days
Proportion of subjects requiring retreatment due to vomiting
Proportion of subjects requiring retreatment due to vomiting within 1 hour after administration of the study drugs
Measured: 1 hour
Proportion of subjects that reports completing a full course of observed TACT
Measured: 3 days
Proportion of subjects that reports completing a full course of observed ACT
Measured: 3 days
proportion of subjects that reports completing a full course of observed TACT or ACT without withdrawal of consent or exclusion from study because of drug related serious adverse event.
Measured: 42 days
Pharmacokinetic profiles
including Cmax and AUC) of artemisinin-derivatives and partner drugs in ACT and TACT treated subjects in correlation with pharmacodynamics measures of drug efficacy
Measured: 42 days
Pharmacokinetic interactions
including Cmax and AUC) of artemisinin-derivatives and partner drugs in ACT and TACT treated subjects in correlation with pharmacodynamics measures of drug efficacy
Measured: 42 days
Plasma levels of partner drugs
Plasma levels of partner drugs in correlation with treatment efficacy and treatment arm
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Sep 2020
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum Malaria (Uncomplicated)Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,583 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923725
- Sponsor's protocol ID
- MAL18004
- Acronym
- DeTACT-Africa
- Status last verified
- Nov 2025
- First submitted
- 9 Apr 2019
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Africa
- ClinicalTrials.gov ID
- NCT03923725
- Acronym / sponsor ID
- DeTACT-Africa / MAL18004
- Keywords
- Artemether, Lumefantrine, Amodiaquine, Artesunate, Piperaquine, Mefloquine, Triple Artemisinin-based Combination Therapy (TACT)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,583 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (ASMQ+PPQ) and the ACTs artemether-lumefantrine+placebo (AL+PBO), artesunate-mefloquine+placebo (ASMQ+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.
Detailed description
Subjects will be randomized to up to four arms: artemether-lumefantrine + amodiaquine, artemether-lumefantrine + placebo, artesunate-mefloquine + piperaquine and artesunate-mefloquine + placebo. As a contingency measure in case of significant differences in the efficacy or safety of one of the combinations being tested and/or study drug expiry or unavailability, subjects may be randomised to 2 arms with a matching ACT-TACT pair, i.e., with artemether-lumefantrine + placebo or artemether-lumefantrine + amodiaquine OR artesunate-mefloquine + placebo or artesunate-mefloquine + piperaquine.
Some sites may randomize between 2 arms only with matching ACT-TACT pairs, i.e., artemether-lumefantrine + placebo or artemether-lumefantrine + amodiaquine OR artesunate-mefloquine + placebo or artesunate-mefloquine + piperaquine. In Rwanda, subjects will be randomized between 2 arms consisting of artemether-lumefantrine + placebo or artemether-lumefantrine + amodiaquine.
In the control arms, the ACT will be co-packed with a matched (appearance) placebo.
In lower transmission settings (Annual Parasite Incidence <50 per 1000 population per year) the treatment will include a single 0.25 mg/kg gametocytocidal dose of primaquine as recommended by the WHO for children ≥10 kg. All drug administrations will be observed.
Subjects will be treated in an in-patient unit for 3 days and followed up weekly up to D63. Microscopy to detect and quantify malaria parasitaemia will be performed daily (more frequently in patients with parasite density of >5000/µL at inclusion) during hospitalization, at all weekly and unscheduled visits. A physical examination and measurements of vital signs along with a symptom questionnaire for tolerability will be performed and recorded through a standardized method at baseline, daily during admission and weekly during follow up through D42 and at all unscheduled visits. Physical exam, vital sign measurements and assessments of symptoms will be performed on D49, D56, and D63 only for patients who are parasitaemic or those who report fever or other symptoms. Electrocardiographs will be performed during admission (H0, H4, H52 or H64) and day 42 of follow up to assess and compare the effect of ACTs and TACTs antimalarials on QT or QTc intervals.
The DeTACT-Africa Trial is funded by UK Aid from the UK government's Foreign, Commonwealth and Development Office.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Artemether-lumefantrine+amodiaquine (AL+AQ) | Experimental | Drug: Artemether-lumefantrine+ Amodiaquine (AL+AQ)Triple ACTs |
| artemether-lumefantrine+placebo (AL+PBO) | Active comparator | Drug: Artemether-lumefantrine + placebo (AL+PBO)ACTs |
| Artesunate-mefloquine+Piperaquine (AS-MQ+PPQ) | Experimental | Drug: Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)Triple ACTs |
| Artesunate-mefloquine+placebo (AS-MQ+PBO) | Active comparator | Drug: Artesunate-mefloquine+placebo (AS-MQ+PBO)ACTs |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or female, aged ≥6 months to <12 years (For Gambia, Rwanda sites only: ≥6 months)
- Ability to take oral medication
- Acute uncomplicated P. falciparum monoinfection
- Asexual P. falciparum parasitaemia: 1,000/µL to ≤10% parasitaemia, determined on a peripheral blood film (At Gambia, Rwanda sites only: For subjects ≥12 years - 1000/µL to 200,000/µL)
- Fever defined as ≥ 37.5°C tympanic temperature or a history of fever within the last 24 hours
Key exclusion criteria (14 listed)
- 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 <15% at screening (For Gambia, Rwanda sites only: For subjects ≥12 years - 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
- In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 14 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemether-lumefantrine+ Amodiaquine (AL+AQ)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: 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. | Drug | Artemether-lumefantrine+amodiaquine (AL+AQ) |
| Artemether-lumefantrine + placebo (AL+PBO)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. | Drug | artemether-lumefantrine+placebo (AL+PBO) |
| Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)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. | Drug | Artesunate-mefloquine+Piperaquine (AS-MQ+PPQ) |
| Artesunate-mefloquine+placebo (AS-MQ+PBO)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. | Drug | Artesunate-mefloquine+placebo (AS-MQ+PBO) |
Primary outcome
42 days Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR).
Time frame: 42 days
42 days Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR).
17 secondary outcomes
63-day PCR corrected and uncorrected efficacy
Time frame: 63 days
42-day PCR uncorrected efficacy
Time frame: 42 days
Parasite clearance half-life
Time frame: 3 Days
Proportion of subjects with microscopically detectable P. falciparum parasitaemia
Time frame: Day 3
Fever clearance time
Time frame: 63 Days
Proportion of subjects with gametocytaemia
Time frame: 63 Days
Incidence of adverse events
Time frame: 42 days
Incidence of serious adverse events
Time frame: 42 days
Number of cardiotoxicity events
Time frame: 52 or 64 hours depends on treatment arm
Change in haemoglobin stratified for G6PD status/genotype
Time frame: 28 days
Proportion of subjects requiring retreatment due to vomiting
Time frame: 1 hour
Proportion of subjects that reports completing a full course of observed TACT
Time frame: 3 days
Proportion of subjects that reports completing a full course of observed ACT
Time frame: 3 days
proportion of subjects that reports completing a full course of observed TACT or ACT without withdrawal of consent or exclusion from study because of drug related serious adverse event.
Time frame: 42 days
Pharmacokinetic profiles
Time frame: 42 days
Pharmacokinetic interactions
Time frame: 42 days
Plasma levels of partner drugs
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Artemether-lumefantrine+ Amodiaquine (AL+AQ) and Artesunate-mefloquine+piperaquine (AS-MQ+PPQ) in people with Plasmodium Falciparum Malaria (Uncomplicated), run by University of Oxford at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Burkina Faso, Democratic Republic of the Congo, Guinea, Nigeria, Niger and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
42 days Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR). (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.