Trial · NCT03355664

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

NCT03355664, Phase 3, Completed, University of Oxford; results first posted 2022-07-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam. Trials, record NCT03355664. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03355664

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam
NCT number: NCT03355664
Status: Completed
Phases: Phase 3
Enrollment: 310 participants, actual
Lead sponsor: University of Oxford
Conditions: Malaria, Falciparum
Interventions: ACT, TACT
First posted: 2017-11-28
Last updated: 2022-07-15
Results first posted: 2022-07-15

Source ClinicalTrials.gov

Registered outcomes28

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Polymerase Chain Reaction Corrected Efficacy Defined as Adequate Clinical and Parasitological Response (ACPR) by Study Arm	42 days	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	42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region	42 day	42-day polymerase chain reaction corrected efficacy defined as adequate clinical and parasitological response (ACPR) according to site/geographic region.
Secondary	Parasite Clearance Half-life	42 day	Parasite clearance half-life assessed by microscopy as primary parameter to determine parasite clearance
Secondary	Fever Clearance Time	42 day	The time taken for the tympanic temperature to fall below 37.5˚C and remain there for at least 24 hours
Secondary	Number of Severe Adverse Events by Study Arm	42 days	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.
Secondary	Incidence of Adverse Events Concerning Markers of Hepatic or Renal Toxicity	42 day	Total bilirubin, Alanine transaminase, Aspartate transaminase, Alkaline phosphatase and creatinine will be measured
Secondary	Incidence of Prolongation of the Corrected QT Interval	28 day	We record the number of events where the QT interval exceeds 500ms or increases by 60ms or greater.
Secondary	Prolongation of the Corrected QT Interval	Hour 4, Hour 24, Hour 28, Hour 48, Hour 52, Hour 60, Hour 64, Day 7 and Day 28 and between these time points	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.
Secondary	Parasite Reduction Rates	24 and 48 hours	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.
Secondary	Parasite Count to Fall 50%	42 days	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.

1 to 10 of 28Source ClinicalTrials.gov

See all 28 registered outcomes

Outcomes28

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Polymerase Chain Reaction Corrected Efficacy Defined as Adequate Clinical and Parasitological Response (ACPR) by Study Arm	42 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region	42 day	The numbers analysed differ from the overall total as for this secondary analysis we report efficacy stratified by each of the 3 study sites.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Parasite Clearance Half-life	42 day		Hours	MEAN
SECONDARY	Fever Clearance Time	42 day		Hours to fever clearance	MEAN
SECONDARY	Number of Severe Adverse Events by Study Arm	42 days		Participants	NUMBER
SECONDARY	Incidence of Adverse Events Concerning Markers of Hepatic or Renal Toxicity	42 day		Events	NUMBER
SECONDARY	Incidence of Prolongation of the Corrected QT Interval	28 day		Events	NUMBER
SECONDARY	Prolongation of the Corrected QT Interval	Hour 4, Hour 24, Hour 28, Hour 48, Hour 52, Hour 60, Hour 64, Day 7 and Day 28 and between these time points		Events	NUMBER
SECONDARY	Parasite Reduction Rates	24 and 48 hours
SECONDARY	Parasite Count to Fall 50%	42 days

1 to 10 of 28Source ClinicalTrials.gov

See all 28 outcomes

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Polymerase Chain Reaction Corrected Efficacy Defined as Adequate Clinical and Parasitological Response (ACPR) by Study Arm	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24		146		Participants
Polymerase Chain Reaction Corrected Efficacy Defined as Adequate Clinical and Parasitological Response (ACPR) by Study Arm	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24		151		Participants
42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	West Cambodia	32		Participants
42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	West Cambodia	35		Participants
42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	East Cambodia	91		Participants
42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	East Cambodia	90		Participants
42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	Vietnam	23		Participants
42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	Vietnam	26		Participants
Parasite Clearance Half-life	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24		5	Standard Deviation 2.5	Hours
Parasite Clearance Half-life	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24		5.5	Standard Deviation 2.6	Hours

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	154
Overall Study	STARTED	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	156
Overall Study	COMPLETED	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	139
Overall Study	COMPLETED	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	144
Overall Study	NOT COMPLETED	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	15
Overall Study	NOT COMPLETED	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	12

Source ClinicalTrials.gov

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	vomiting	Gastrointestinal disorders	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	3	154
other	vomiting	Gastrointestinal disorders	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	12	156
other	nausea	Gastrointestinal disorders	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	3	154
other	nausea	Gastrointestinal disorders	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	11	156
other	dizziness	General disorders	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	9	154
other	dizziness	General disorders	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	16	156
other	abdominal pain	Gastrointestinal disorders	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	19	154
other	abdominal pain	Gastrointestinal disorders	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	22	156
other	diarrhoea	Gastrointestinal disorders	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	13	154
other	diarrhoea	Gastrointestinal disorders	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	17	156

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	0	154
Total, all-cause mortality	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	0	156
Total, other adverse events	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	122	154
Total, other adverse events	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	141	156
Total, serious adverse events	Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24	2	154
Total, serious adverse events	Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24	5	156

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35276064	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 vs 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	Trial comparisons
Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 vs Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24: Number of Severe Adverse Events by Study Arm	Trial comparisons
Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 vs Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24: deaths from any cause	Trial comparisons
Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24 vs Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03355664

GET https://conductscience.org/api/trials/v1/NCT03355664/registered?page=2

API reference For AI assistants