Plasmodium Falciparum Malaria (Uncomplicated)Phase 3DeTACT-ASIANCT03939104
A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combinations of 2 Anti-malarial Drugs (Asia)
A Phase 3 study testing Artemether-lumefantrine+amodiaquine and Artesunate-mefloquine+piperaquine in people with Plasmodium Falciparum Malaria (Uncomplicated), run by University of Oxford at 3 sites in 2 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 (AS-MQ+PPQ) with the ACTs artemether-lumefantrine + placebo (AL+PBO) and artesunate- mefloquine + placebo… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Plasmodium Falciparum Malaria (Uncomplicated)
- What is being tested?
- Artemether-lumefantrine+amodiaquine and Artesunate-mefloquine+piperaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Jun 2021to 28 Jan 2023
- 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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 < 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
Show all 24Show fewer
- 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)
- Prostration
- Respiratory distress (defined as maximal respiratory rate, by age)
- ≥2 convulsions in the past 24 hours
- Circulatory collapse
- Pulmonary edema
- Abnormal bleeding
- Visible jaundice
- Haemoglobinuria (blackwater)
- Hyperparasitaemia (>10%)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Cambodia2 sites
Kravanh Referral Hospital
Phnum Kravanh, Pursat, 150501
Siem Pang Health Center
Siem Pang, Stung Treng, 1803
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 Asia
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.
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 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-ASIA Trial is funded by UK Aid from the UK government's Foreign, Commonwealth and Development Office (FCDO). The FCDO project number is 300341-114.
- Being tested
- Artemether-lumefantrine+amodiaquine, Artemether-lumefantrine+placebo, Artesunate-mefloquine+piperaquine, Artesunate-mefloquine+placebo
- Keywords
- Artemether, Lumefantrine, Amodiaquine, Piperaquine, Artesunate, Mefloquine
- 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+amodiaquineDrug
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.
Artemether-lumefantrine+placeboDrug
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+piperaquineDrug
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+placeboDrug
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) | Active comparator | Triple ACTs Receives: Drug: Artemether-lumefantrine+amodiaquine |
| Artesunate-mefloquine+piperaquine (AS-MQ+PPQ) | Active comparator | Triple ACTs Receives: Drug: Artesunate-mefloquine+piperaquine |
| artemether-lumefantrine+placebo (AL+PBO) | Active comparator | ACTs Receives: Drug: Artemether-lumefantrine+placebo |
| Artesunate-mefloquine+placebo (AS-MQ+PBO) | Active comparator | ACTs. Receives: Drug: Artesunate-mefloquine+placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR).
Measured: 42 days
Secondary outcomes (17)
Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR)
Measured: 63-day
Efficacy defined as adequate clinical and parasitological response (PCR)
Measured: 63-day
Efficacy defined as adequate clinical and parasitological response (ACPR)
Measured: 42-day
Parasite clearance half-life
Measured: 7 days
proportion of subjects with microscopically detectable P. falciparum parasitaemia
Measured: 3 days
Fever clearance time
Time taken for the tympanic temperature to fall below 37.5 ºC in patients who were febrile at inclusion
Measured: 7 days
Proportion of subjects with gametocytemia during and after treatment stratified by presence of gametocytes at enrolment
Measured: 63 days
Number of adverse events
Measured: 42 days
Number of serious adverse events
Including markers of hepatic, renal or bone marrow toxicity
Measured: 42 days
Number of cardiotoxicity events
In particular QTc-interval above 500 ms or an increase > 60 ms above baseline values 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 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
Pharmacokinetic profiles and interactions (including Cmax) of artemisinin-derivatives and partner drugs in ACT and TACT treated subjects in correlation with pharmacodynamics measures of drug efficacy
Measured: 42 days
Pharmacokinetic profiles and interactions (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 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 posted6 May 2019
- Study start30 Jun 2021
- Primary completion6 Jan 2023
- Study completion28 Jan 2023
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
- Model description
- 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) and the ACTs artemether-lumefantrine+placebo (AL+PBO), 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 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
- NCT03939104
- Sponsor's protocol ID
- MAL18005
- Acronym
- DeTACT-ASIA
- Status last verified
- May 2023
- First submitted
- 29 Apr 2019
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. 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 Asia
- ClinicalTrials.gov ID
- NCT03939104
- Acronym / sponsor ID
- DeTACT-ASIA / MAL18005
- Keywords
- Artemether, Lumefantrine, Amodiaquine, Piperaquine, Artesunate, Mefloquine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 6 May 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 (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.
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 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-ASIA Trial is funded by UK Aid from the UK government's Foreign, Commonwealth and Development Office (FCDO). The FCDO project number is 300341-114.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 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) and the ACTs artemether-lumefantrine+placebo (AL+PBO), 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.
| Arm | Type | Receives |
|---|---|---|
| Artemether-lumefantrine+amodiaquine (AL+AQ) | Active comparator | Drug: Artemether-lumefantrine+amodiaquineTriple ACTs |
| Artesunate-mefloquine+piperaquine (AS-MQ+PPQ) | Active comparator | Drug: Artesunate-mefloquine+piperaquineTriple ACTs |
| artemether-lumefantrine+placebo (AL+PBO) | Active comparator | Drug: Artemether-lumefantrine+placeboACTs |
| Artesunate-mefloquine+placebo (AS-MQ+PBO) | Active comparator | Drug: Artesunate-mefloquine+placeboACTs. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (24 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 < 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
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+amodiaquineAL: 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. | Drug | Artemether-lumefantrine+amodiaquine (AL+AQ) |
| Artemether-lumefantrine+placeboAL: 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+piperaquineAS: 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+placeboAS: 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
Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR).
Time frame: 42 days
17 secondary outcomes
Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR)
Time frame: 63-day
Efficacy defined as adequate clinical and parasitological response (PCR)
Time frame: 63-day
Efficacy defined as adequate clinical and parasitological response (ACPR)
Time frame: 42-day
Parasite clearance half-life
Time frame: 7 days
proportion of subjects with microscopically detectable P. falciparum parasitaemia
Time frame: 3 days
Fever clearance time
Time frame: 7 days
Proportion of subjects with gametocytemia during and after treatment stratified by presence of gametocytes at enrolment
Time frame: 63 days
Number of adverse events
Time frame: 42 days
Number 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 within 1 hour after administration of the study drugs
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
Pharmacokinetic profiles and interactions (including Cmax) of artemisinin-derivatives and partner drugs in ACT and TACT treated subjects in correlation with pharmacodynamics measures of drug efficacy
Time frame: 42 days
Pharmacokinetic profiles and interactions (AUC) of artemisinin-derivatives and partner drugs in ACT and TACT treated subjects in correlation with pharmacodynamics measures of drug efficacy
Time frame: 42 days
Plasma levels of partner drugs in correlation with treatment efficacy and treatment arm
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 20 Mar 2024.
- 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.
3 sites in 2 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 and Artesunate-mefloquine+piperaquine in people with Plasmodium Falciparum Malaria (Uncomplicated), run by University of Oxford at 3 sites in 2 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 24 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cambodia, Bangladesh. 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?
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 20 Mar 2024.