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Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam (TACT-CV)

Primary Purpose

Malaria, Falciparum

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ACT

TACT

About this trial

This is an interventional treatment trial for Malaria, Falciparum focused on measuring Malaria, Falciparum, Malaria, Protozoan Infections, Lumefantrine, Artemether, Amodiaquine, Piperaquine, Artemether-lumefantrine combination, Artemisinins, Dihydroartemisinin, Mefloquine, Artemisinin, Antimalarials, Antiparasitic Agents, Anti-Infective Agents, ACT, TACT, Triple ACT(s), Resistance, Antimalarial resistance, Cardiotoxicity, Safety, Tolerability, Efficacy

Eligibility Criteria

2 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, aged from 2 years to 65 years old
Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum (or mixed with non-falciparum species)
Asexual P. falciparum parasitaemia: 16 to 200,000/microlitre, determined on a thin or thick blood film
Fever defined as > 37.5°C tympanic temperature or a history of fever within the last 24 hours
Written informed consent (by parent/guardian in case of children)
Willingness and ability of the patients or parents/guardians to comply with the study protocol for the duration of the study

Exclusion Criteria:

Signs of severe/complicated malaria
Haematocrit < 25% or Hb < 8 g/dL at screening
Acute illness other than malaria requiring treatment
For females: pregnancy, breast feeding
Patients who have received artemisinin or a derivative or an artemisinin-containing combination therapy (ACT) within the previous 7 days
History of allergy or known contraindication to artemisinins, lumefantrine or amodiaquine
Previous splenectomy
corrected QT interval > 450 milliseconds at moment of presentation
Documented or claimed history of cardiac conduction problems
Previous participation in the current study or another study in the previous 3 months

Sites / Locations

Siem Pang Health Center
Pailin Referral Hospital
Hospital for Tropical Diseases of Khanh Hoa,
Phuoc Long Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ACT

TACT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Parasite Clearance Half-life

Parasite clearance half-life assessed by microscopy as primary parameter to determine parasite clearance

Fever Clearance Time

The time taken for the tympanic temperature to fall below 37.5˚C and remain there for at least 24 hours

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.

Incidence of Adverse Events Concerning Markers of Hepatic or Renal Toxicity

Total bilirubin, Alanine transaminase, Aspartate transaminase, Alkaline phosphatase and creatinine will be measured

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03355664

First Posted

November 1, 2017

Last Updated

March 17, 2022

Sponsor

University of Oxford

1. Study Identification

Unique Protocol Identification Number

NCT03355664

Brief Title

Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam

Acronym

TACT-CV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

March 19, 2018 (Actual)

Primary Completion Date

March 4, 2020 (Actual)

Study Completion Date

March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

"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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria, Falciparum

Keywords

Malaria, Falciparum, Malaria, Protozoan Infections, Lumefantrine, Artemether, Amodiaquine, Piperaquine, Artemether-lumefantrine combination, Artemisinins, Dihydroartemisinin, Mefloquine, Artemisinin, Antimalarials, Antiparasitic Agents, Anti-Infective Agents, ACT, TACT, Triple ACT(s), Resistance, Antimalarial resistance, Cardiotoxicity, Safety, Tolerability, Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

open-label randomised trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

310 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACT

Arm Type

Active Comparator

Arm Description

Artemether-lumefantrine for 3 days plus primaquine at hour 24

Arm Title

TACT

Arm Type

Experimental

Arm Description

Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days plus primaquine at hour 24

Intervention Type

Drug

Intervention Name(s)

ACT

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

TACT

Intervention Description

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

Primary Outcome Measure Information:

Title

Polymerase Chain Reaction Corrected Efficacy Defined as Adequate Clinical and Parasitological Response (ACPR) by Study Arm

Description

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

Secondary Outcome Measure Information:

Title

42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region

Description

42-day polymerase chain reaction corrected efficacy defined as adequate clinical and parasitological response (ACPR) according to site/geographic region.

Time Frame

42 day

Title

Parasite Clearance Half-life

Description

Parasite clearance half-life assessed by microscopy as primary parameter to determine parasite clearance

Time Frame

42 day

Title

Fever Clearance Time

Description

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

Title

Number of Severe Adverse Events by Study Arm

Description

Time Frame

42 days

Title

Incidence of Adverse Events Concerning Markers of Hepatic or Renal Toxicity

Description

Total bilirubin, Alanine transaminase, Aspartate transaminase, Alkaline phosphatase and creatinine will be measured

Time Frame

42 day

Title

Incidence of Prolongation of the Corrected QT Interval

Description

We record the number of events where the QT interval exceeds 500ms or increases by 60ms or greater.

Time Frame

28 day

Title

Prolongation of the Corrected QT Interval

Description

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

Title

Parasite Reduction Rates

Description

Time Frame

24 and 48 hours

Title

Parasite Count to Fall 50%

Description

Time Frame

42 days

Title

Parasite Count to Fall 90%

Description

Time Frame

42 days

Title

Parasite Count to Fall 99%

Description

Time Frame

42 days

Title

Change in Haematocrit

Description

Time Frame

Day 1 to 7, 14, 21, 28, 35, 42

Title

Correlation Between the Host Genotype and the Pharmacokinetics and Pharmacodynamics of Antimalarials

Description

Time Frame

42 day

Title

Proportion of Patients That Reports Completing a Full Course of Observed TACT or ACT

Description

Time Frame

42 day

Title

Prevalence of Kelch13 Mutations of Known Significance

Description

Time Frame

42 day

Title

Prevalence/Incidence of Other Genetic Markers of Antimalarial Drug Resistance Such as Multidrug Resistance Gene 1 Copy Number and Multidrug Resistance Gene 1 Mutations

Description

Time Frame

48 hours

Title

Genome Wide Association With in Vivo/in Vitro Sensitivity Parasite Phenotype

Description

Time Frame

42 day

Title

Correlation Between Single Nucleotide Polymorphisms and Whole Genome Sequencing

Description

Time Frame

42 day

Title

A Comparison of Transcriptomic Patterns Between Sensitive and Resistant Parasites

Description

Time Frame

baseline and t = 6 hours

Title

Correlation Between Quantitative Polymerase Chain Reaction Based Versus Microscopy Based Assessments of Parasite Clearance Dynamics

Description

Time Frame

14 days

Title

Proportion of Patients With Gametocytaemia Before, During and After Treatment With TACT or ACT

Description

Time Frame

At admission and up to day 14

Title

Levels of RNA Transcription Coding for Male or Female Specific Gametocytes

Description

Time Frame

14 days

Title

In Vitro Sensitivity of P. Falciparum to Artemisinins and Partner Drugs

Description

Time Frame

At admission & subjects with recurrent parasitaemia, up to 42 days

Title

Pharmacokinetic Profiles and Interactions (Cmax) of Artemisinin-derivatives and Partner Drugs

Description

Time Frame

42 days

Title

Pharmacokinetic Profiles and Interactions (AUC) of Artemisinin-derivatives and Partner Drugs

Description

Time Frame

42 days

Title

Day 7 Drug Levels of Partner Drugs in Association With Treatment Efficacy and Treatment Arm

Description

Time Frame

7 days

Title

Correlation Between Histidine-rich Protein 2 (HRP2) Based Versus Microscopy Based Assessments of Parasite Clearance Dynamics

Description

Time Frame

42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, aged from 2 years to 65 years old Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum (or mixed with non-falciparum species) Asexual P. falciparum parasitaemia: 16 to 200,000/microlitre, determined on a thin or thick blood film Fever defined as > 37.5°C tympanic temperature or a history of fever within the last 24 hours Written informed consent (by parent/guardian in case of children) Willingness and ability of the patients or parents/guardians to comply with the study protocol for the duration of the study Exclusion Criteria: Signs of severe/complicated malaria Haematocrit < 25% or Hb < 8 g/dL at screening Acute illness other than malaria requiring treatment For females: pregnancy, breast feeding Patients who have received artemisinin or a derivative or an artemisinin-containing combination therapy (ACT) within the previous 7 days History of allergy or known contraindication to artemisinins, lumefantrine or amodiaquine Previous splenectomy corrected QT interval > 450 milliseconds at moment of presentation Documented or claimed history of cardiac conduction problems Previous participation in the current study or another study in the previous 3 months

Facility Information:

Facility Name

Siem Pang Health Center

City

Siem Pang

State/Province

Stung Treng

ZIP/Postal Code

1803

Country

Cambodia

Facility Name

Pailin Referral Hospital

City

Pailin

ZIP/Postal Code

2401

Country

Cambodia

Facility Name

Hospital for Tropical Diseases of Khanh Hoa,

City

Van Ninh

State/Province

Khanh Hoa

Country

Vietnam

Facility Name

Phuoc Long Hospital

City

Phuoc Long

State/Province

Phuoc

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35276064

Citation

Peto TJ, Tripura R, Callery JJ, Lek D, Nghia HDT, Nguon C, Thuong NTH, van der Pluijm RW, Dung NTP, Sokha M, Van Luong V, Long LT, Sovann Y, Duanguppama J, Waithira N, Hoglund RM, Chotsiri P, Chau NH, Ruecker A, Amaratunga C, Dhorda M, Miotto O, Maude RJ, Rekol H, Chotivanich K, Tarning J, von Seidlein L, Imwong M, Mukaka M, Day NPJ, Hien TT, White NJ, Dondorp AM. Triple therapy with artemether-lumefantrine plus amodiaquine versus artemether-lumefantrine alone for artemisinin-resistant, uncomplicated falciparum malaria: an open-label, randomised, multicentre trial. Lancet Infect Dis. 2022 Jun;22(6):867-878. doi: 10.1016/S1473-3099(21)00692-7. Epub 2022 Mar 8. Erratum In: Lancet Infect Dis. 2022 May;22(5):e128.

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Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam

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