A Phase 3 interventional study of ACT and TACT in Malaria, Falciparum, sponsored by University of Oxford. Completed at 4 sites in 2 countries. Open to participants aged 2 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by University of Oxford · Phase 3, Interventional, and Treatment
This study is a multi-centre, open-label randomised trial to assess the efficacy, safety and tolerability of the Triple ACT artemether-lumefantrine+amodiaquine (AL+AQ) compared to the ACT artemether-lumefantrine (AL) in uncomplicated falciparum malaria in Cambodia and Vietnam. The estimated total sample size is 600 patients from 2 sites in Cambodia and 2 sites in Vietnam. There are 2 treatment arms Arm 1: Artemether-lumefantrine for 3 days Arm 2: Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days. According to the World Health Organization guideline, all patients except children under 10 kilograms will also be treated with a single dose of primaquine as a gametocytocidal treatment.
Funder :Bill \& Melinda Gates Foundation (BMGF) Grant reference number: OPP1132628
"The study of artemether-lumefantrine or artemether-lumefantrine combined with amodiaquine will be a two-arm randomized open label comparative study.
The main activity proposed is a series of detailed in vivo clinical, parasitological and pharmacological assessments in 600 subjects across 2 sites in Cambodian (400 subjects) and 2 sites in Vietnam (200 subjects). The subjects will be randomized between the ACT artemether-lumefantrine and the TACT artemether-lumefantrine+amodiaquine.
Parasite clearance rates will be assessed by repeated assessments of the parasite counts after the start of the antimalarial treatments. Efficacy, safety and tolerability of ACTs and TACTs will be assessed through weekly follow up visits where vital signs, symptom questionnaires, physical examinations, blood smears, biochemistry assays and full blood counts will be performed.
Ex vivo assessments of parasite susceptibility to artemisinins and partner drugs will be measured and compared to historical data, clinical phenotype and other sites in an effort to identify artemisinin and partner drug resistance.
This study will obtain data on the effect of antimalarials on the corrected QT intervals. In addition, the effects of antimalarials on factors such as post-treatment haematocrit and haemoglobin levels will be assessed. Extensive pharmacokinetic analysis will allow for an assessment of drug-drug interactions.
Plasma histidine-rich protein 2 (HRP2) levels (a marker of parasite biomass) that could potentially serve for the estimation of parasitaemia dynamics before and after treatment will be measured and subsequently modelled."
390 studies on the registry are indexed under Malaria, Falciparum; 35 are open to participants now.
This study's enrollment of 310 is above the median of 127 across 325 interventional studies indexed under Malaria, Falciparum.
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Exclusion Criteria:
Artemether-lumefantrine for 3 days plus primaquine at hour 24
Drug: ACT
Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days plus primaquine at hour 24
Drug: TACT
Artemether-lumefantrine (20/120 mg) as a fixed dose combination twice daily for 3 days according to weight plus low dose primaquine at hour 24
Artemether-lumefantrine (20/120 mg) as a fixed dose combination twice daily for 3 days according to weight plus Amodiaquine (150mg) twice daily for 3 days according to weight plus low dose primaquine at hour 24
Polymerase Chain Reaction Corrected Efficacy Defined as Adequate Clinical and Parasitological Response (ACPR) by Study Arm
Efficacy is defined as participants, following initial parasite and fever clearance, not having a recrudescence of the original plasmodium infection and fever, up to 42 days of follow up.
Time frame: 42 days
42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region
42-day polymerase chain reaction corrected efficacy defined as adequate clinical and parasitological response (ACPR) according to site/geographic region.
Time frame: 42 day
Parasite Clearance Half-life
Parasite clearance half-life assessed by microscopy as primary parameter to determine parasite clearance
Time frame: 42 day
Fever Clearance Time
The time taken for the tympanic temperature to fall below 37.5˚C and remain there for at least 24 hours
Time frame: 42 day
Number of Severe Adverse Events by Study Arm
All numerators in AE tables mean that the AE was reported as present according to the definitions defined in the US government DAIDS 2017 grading tables for reporting of adverse events. The AEs are reported without grading in this table, but are graded in the paper reporting this clinical trial. All Primary analyses are reported (also in the accepted manuscript) along with the secondary outcomes needed to support the primary analysis. Secondary outcomes not involving the randomised comparison will be updated when the analyses are available. Please note that analyses of these Secondary outcomes will take time.
Time frame: 42 days
Incidence of Adverse Events Concerning Markers of Hepatic or Renal Toxicity
Total bilirubin, Alanine transaminase, Aspartate transaminase, Alkaline phosphatase and creatinine will be measured
Time frame: 42 day
Incidence of Prolongation of the Corrected QT Interval
We record the number of events where the QT interval exceeds 500ms or increases by 60ms or greater.
Time frame: 28 day
Prolongation of the Corrected QT Interval
We record the number of events where the QT interval exceeds 500ms or increases by 60ms or greater. There were zero events of this at any time point in either study arm. So no further analyses are possible.
Time frame: Hour 4, Hour 24, Hour 28, Hour 48, Hour 52, Hour 60, Hour 64, Day 7 and Day 28 and between these time points
Parasite Reduction Rates
Parasite reduction rates and ratios at 24 and 48 hours assessed by microscopy The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 24 and 48 hours
Parasite Count to Fall 50%
Time for parasite count to fall 50% of initial parasite density The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 42 days
Parasite Count to Fall 90%
Time for parasite count to fall 90% of initial parasite density The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 42 days
Parasite Count to Fall 99%
Time for parasite count to fall 99% of initial parasite density The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 42 days
Change in Haematocrit
Change in haematocrit at specified time points according to geographical location and study arm, stratified for G6PD status The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: Day 1 to 7, 14, 21, 28, 35, 42
Correlation Between the Host Genotype and the Pharmacokinetics and Pharmacodynamics of Antimalarials
Correlation between the host genotype and the pharmacokinetics and pharmacodynamics of antimalarials The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 42 day
Proportion of Patients That Reports Completing a Full Course of Observed TACT or ACT
Proportion of patients 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 The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 42 day
Prevalence of Kelch13 Mutations of Known Significance
Prevalence of Kelch13 mutations of known significance The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 42 day
Prevalence/Incidence of Other Genetic Markers of Antimalarial Drug Resistance Such as Multidrug Resistance Gene 1 Copy Number and Multidrug Resistance Gene 1 Mutations
Prevalence/incidence of other genetic markers of antimalarial drug resistance such as multidrug resistance gene 1 copy number and multidrug resistance gene 1 mutations The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 48 hours
Genome Wide Association With in Vivo/in Vitro Sensitivity Parasite Phenotype
Genome wide association with in vivo/in vitro sensitivity parasite phenotype The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 42 day
Correlation Between Single Nucleotide Polymorphisms and Whole Genome Sequencing
Correlation between single nucleotide polymorphisms measured in dry blood spots and whole genome sequencing in leukocyte depleted blood samples The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 42 day
A Comparison of Transcriptomic Patterns Between Sensitive and Resistant Parasites
Transcriptomic patterns measure at baseline and at specified time points after the start of treatment comparing sensitive and resistant parasites. The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: baseline and t = 6 hours
Correlation Between Quantitative Polymerase Chain Reaction Based Versus Microscopy Based Assessments of Parasite Clearance Dynamics
Correlation between qPCR based versus microscopy based assessments of parasite clearance dynamics The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 14 days
Proportion of Patients With Gametocytaemia Before, During and After Treatment With TACT or ACT
Proportion of patients with gametocytaemia before, during and after treatment with TACT or ACT stratified by the presence of gametocytes at enrolment The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: At admission and up to day 14
Levels of RNA Transcription Coding for Male or Female Specific Gametocytes
Levels of RNA transcription coding for male or female specific gametocytes at admission up to day 14, stratified by the presence of gametocytes at enrolment The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 14 days
In Vitro Sensitivity of P. Falciparum to Artemisinins and Partner Drugs
In vitro sensitivity of P. falciparum to artemisinins and partner drugs according to study sites and genotype The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: At admission & subjects with recurrent parasitaemia, up to 42 days
Pharmacokinetic Profiles and Interactions (Cmax) of Artemisinin-derivatives and Partner Drugs
Pharmacokinetic profiles and interactions (Cmax) of artemisinin-derivatives and partner drugs in 20 ACT treated and 20 TACT treated patients of both study arms in Vietnam The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 42 days
Pharmacokinetic Profiles and Interactions (AUC) of Artemisinin-derivatives and Partner Drugs
Pharmacokinetic profiles and interactions (AUC) of artemisinin-derivatives and partner drugs in 20 ACT treated and 20 TACT treated patients of both study arms in Vietnam The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 42 days
Day 7 Drug Levels of Partner Drugs in Association With Treatment Efficacy and Treatment Arm
Day 7 drug levels of partner drugs in association with treatment efficacy and treatment arm The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 7 days
Correlation Between Histidine-rich Protein 2 (HRP2) Based Versus Microscopy Based Assessments of Parasite Clearance Dynamics
Correlation between histidine-rich protein 2 (HRP2) based versus microscopy based assessments of parasite clearance dynamics The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Time frame: 42 days
Enrolled at hospitals and health centres 18 March 2018 to 30 January 2020
| Milestone | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 |
|---|---|---|
| Started | 154 | 156 |
| Completed | 139 | 144 |
| Not completed | 15 | 12 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Lost to follow-up | 11 | 7 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Withdrawal by subject | 2 | 1 |
Efficacy is defined as participants, following initial parasite and fever clearance, not having a recrudescence of the original plasmodium infection and fever, up to 42 days of follow up.
| Participants | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 |
|---|---|---|
| Polymerase Chain Reaction Corrected Efficacy Defined as Adequate Clinical and Parasitological Response (ACPR) by Study Arm | 146 | 151 |
42-day polymerase chain reaction corrected efficacy defined as adequate clinical and parasitological response (ACPR) according to site/geographic region.
| Participants | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 |
|---|---|---|
| West Cambodia | 32 | 35 |
| East Cambodia | 91 | 90 |
| Vietnam | 23 | 26 |
Parasite clearance half-life assessed by microscopy as primary parameter to determine parasite clearance
| Hours | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 |
|---|---|---|
| Parasite Clearance Half-life | 5 ± 2.5 | 5.5 ± 2.6 |
The time taken for the tympanic temperature to fall below 37.5˚C and remain there for at least 24 hours
| Hours to fever clearance | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 |
|---|---|---|
| Fever Clearance Time | 18.3 ± 12.6 | 14.9 ± 9.9 |
All numerators in AE tables mean that the AE was reported as present according to the definitions defined in the US government DAIDS 2017 grading tables for reporting of adverse events. The AEs are reported without grading in this table, but are graded in the paper reporting this clinical trial. All Primary analyses are reported (also in the accepted manuscript) along with the secondary outcomes needed to support the primary analysis. Secondary outcomes not involving the randomised comparison will be updated when the analyses are available. Please note that analyses of these Secondary outcomes will take time.
| Participants | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 |
|---|---|---|
| Number of Severe Adverse Events by Study Arm | 2 | 5 |
Total bilirubin, Alanine transaminase, Aspartate transaminase, Alkaline phosphatase and creatinine will be measured
| Events | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 |
|---|---|---|
| Incidence of Adverse Events Concerning Markers of Hepatic or Renal Toxicity | 53 | 63 |
We record the number of events where the QT interval exceeds 500ms or increases by 60ms or greater.
| Events | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 |
|---|---|---|
| Incidence of Prolongation of the Corrected QT Interval | 0 | 0 |
We record the number of events where the QT interval exceeds 500ms or increases by 60ms or greater. There were zero events of this at any time point in either study arm. So no further analyses are possible.
| Events | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 |
|---|---|---|
| Prolongation of the Corrected QT Interval | 0 | 0 |
Parasite reduction rates and ratios at 24 and 48 hours assessed by microscopy The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Time for parasite count to fall 50% of initial parasite density The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Time for parasite count to fall 90% of initial parasite density The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Time for parasite count to fall 99% of initial parasite density The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Change in haematocrit at specified time points according to geographical location and study arm, stratified for G6PD status The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Correlation between the host genotype and the pharmacokinetics and pharmacodynamics of antimalarials The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Proportion of patients 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 The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Prevalence of Kelch13 mutations of known significance The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Prevalence/incidence of other genetic markers of antimalarial drug resistance such as multidrug resistance gene 1 copy number and multidrug resistance gene 1 mutations The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Genome wide association with in vivo/in vitro sensitivity parasite phenotype The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Correlation between single nucleotide polymorphisms measured in dry blood spots and whole genome sequencing in leukocyte depleted blood samples The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Transcriptomic patterns measure at baseline and at specified time points after the start of treatment comparing sensitive and resistant parasites. The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Correlation between qPCR based versus microscopy based assessments of parasite clearance dynamics The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Proportion of patients with gametocytaemia before, during and after treatment with TACT or ACT stratified by the presence of gametocytes at enrolment The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Levels of RNA transcription coding for male or female specific gametocytes at admission up to day 14, stratified by the presence of gametocytes at enrolment The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
In vitro sensitivity of P. falciparum to artemisinins and partner drugs according to study sites and genotype The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Pharmacokinetic profiles and interactions (Cmax) of artemisinin-derivatives and partner drugs in 20 ACT treated and 20 TACT treated patients of both study arms in Vietnam The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Pharmacokinetic profiles and interactions (AUC) of artemisinin-derivatives and partner drugs in 20 ACT treated and 20 TACT treated patients of both study arms in Vietnam The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Day 7 drug levels of partner drugs in association with treatment efficacy and treatment arm The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Correlation between histidine-rich protein 2 (HRP2) based versus microscopy based assessments of parasite clearance dynamics The data are collected, but this secondary outcome will come from analyses done by specialist researchers and the results will not affect the the presently reported primary outcomes of efficacy, safety and tolerability. These fields will be updated once results become available. We will also provide a link to the paper reporting the trial when it is published online as this will provide additional detail about the study.
Results for this outcome have not been posted.
Collected over 42 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | 0/154 (0%) | 2/154 (1.3%) | 122/154 (79.2%) |
| Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 | 0/156 (0%) | 5/156 (3.2%) | 141/156 (90.4%) |
| Event | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 |
|---|---|---|
| severe malariaInfections and infestations | 0/154 | 2/156 |
| dengueInfections and infestations | 1/154 | 0/156 |
| anaemiaBlood and lymphatic system disorders | 1/154 | 0/156 |
| gastritisGastrointestinal disorders | 0/154 | 1/156 |
| vomitingGastrointestinal disorders | 0/154 | 1/156 |
| TransaminitisHepatobiliary disorders | 0/154 | 1/156 |
| Event | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 |
|---|---|---|
| anaemiaBlood and lymphatic system disorders | 27/154 | 46/156 |
| thrombocytopeniaBlood and lymphatic system disorders | 38/154 | 33/156 |
| aspartate transferase (AST)Hepatobiliary disorders | 17/154 | 24/156 |
| abdominal painGastrointestinal disorders | 19/154 | 22/156 |
| alanyl transferase (ALT)Hepatobiliary disorders | 16/154 | 21/156 |
| headacheGeneral disorders | 19/154 | 20/156 |
| diarrhoeaGastrointestinal disorders | 13/154 | 17/156 |
| dizzinessGeneral disorders | 9/154 | 16/156 |
| fatigueGeneral disorders | 11/154 | 15/156 |
| alkaline phosphatase (ALP)Hepatobiliary disorders | 14/154 | 8/156 |
| Age, Continuous(years) | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 | Total |
|---|---|---|---|
| Median | 24 (18 to 34) | 25 (19 to 33) | 25 (18 to 34) |
| Sex: Female, Male(Participants) | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 | Total |
|---|---|---|---|
| Female | 12 | 24 | 36 |
| Male | 142 | 132 | 274 |
| Race and Ethnicity Not Collected(Participants) | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 | Total |
|---|---|---|---|
| Vietnam | 25 | 26 | 51 |
| Cambodia | 129 | 130 | 259 |
| Tympanic temperature ≥37·5°C(Participants) | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 | Total |
|---|---|---|---|
| Count of participants | 81 | 83 | 164 |
| Weight(kilograms (kg)) | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 | Total |
|---|---|---|---|
| Mean | 51 ± 11 | 51 ± 12 | 51 ± 12 |
| Height(centimeters (cm)) | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 | Total |
|---|---|---|---|
| Mean | 158 ± 12 | 157 ± 14 | 158 ± 13 |
| Heart rate(beats per minute (bpm)) | Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 | Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24 | Total |
|---|---|---|---|
| Median | 89 (78 to 97) | 90 (81 to 104) | 90 (79 to 101) |
11 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from Mar 2018 to primary completion in Mar 2020, 23 months.
Results were first posted in Jul 2022, 2 years 4 months after primary completion.
Of 15 phase 3 interventional studies under Malaria, Falciparum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 35. This study's 23 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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