Trial · NCT00440999

Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria

NCT00440999, Phase 3, Completed, Medicines for Malaria Venture; results first posted 2021-09-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria. Trials, record NCT00440999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00440999

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Trial

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

Title: Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria
NCT number: NCT00440999
Status: Completed
Phases: Phase 3
Enrollment: 456 participants, actual
Lead sponsor: Medicines for Malaria Venture
Conditions: Malaria
Interventions: Pyronaridine artesunate, Chloroquine
First posted: 2007-02-27
Last updated: 2021-11-02
Results first posted: 2021-09-20

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Crude Cure Rate on Day 14	Day 14	Cure rate on Day 14 is defined as the absence of P. vivax parasitaemia on Day 14 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period.
Secondary	Crude Cure Rate on Days 21 and 28.	Day 21 and 28	Cure on Day 21 and 28 is defined as the absence of P. vivax parasitaemia on Day 21 and 28 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period.
Secondary	Parasite Clearance Time	Days 0 to 42	Parasite clearance time is defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance is defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart.
Secondary	Fever Clearance Time	Days 0 to 42	Fever clearance time is defined as the time from first dosing to the first normal reading of temperature (\<37.5°C for axillary/tympanic or \<38°C for oral/rectal) for 2 consecutive normal temperature readings taken between 7 and 25 hours apart.
Secondary	Percentage of Subjects With Parasite Clearance on Days 1, 2, and 3	Days 1, 2, and 3	Percentage of subjects with parasite clearance on Day 1 (24 hours after first dose), Day 2 (48 hours after first dose), and Day 3 (72 hours after first dose).
Secondary	Percentage of Subjects With Fever Clearance on Days 1, 2, and 3	Day 1, 2, and 3	Percentage of subjects with fever clearance on Day 1 (24 hours after first dose), Day 2 (48 hours after first dose), and Day 3 (72 hours after first dose).
Secondary	Number of Participants With Adverse Events	Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier	Number of participants with adverse events, including clinically significant laboratory results, ECG, vital signs or physical examination abnormalities.
Other	Percentage of Subjects With PCR-corrected Cure Rate on Days 14, 21, and 28	Day 14, 21, and 28	Cure on Days 14, 21, and 28 is defined as the absence of P. vivax parasitaemia on Days 14, 21, and 28 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period.
Other	Percentage of Subjects With Crude and PCR-corrected Cure Rate on Day 42	Day 42	Cure on Day 42 is defined as the absence of P. vivax parasitaemia on Day 42 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Crude Cure Rate on Day 14	Day 14	Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Crude Cure Rate on Days 21 and 28.	Day 21 and 28	Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations.	percentage of cured subjects	NUMBER
SECONDARY	Parasite Clearance Time	Days 0 to 42	Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations.	hours	MEDIAN
SECONDARY	Fever Clearance Time	Days 0 to 42	Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations.	hours	MEDIAN
SECONDARY	Percentage of Subjects With Parasite Clearance on Days 1, 2, and 3	Days 1, 2, and 3	Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations.	percentage of subjects	NUMBER
SECONDARY	Percentage of Subjects With Fever Clearance on Days 1, 2, and 3	Day 1, 2, and 3	Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations.	percentage of subjects	NUMBER
SECONDARY	Number of Participants With Adverse Events	Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier	Safety population consists of all randomized subjects who received any amount of study medication, subjects were analyzed as treated.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Percentage of Subjects With PCR-corrected Cure Rate on Days 14, 21, and 28	Day 14, 21, and 28	Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations.	percentage of subjects	NUMBER
OTHER_PRE_SPECIFIED	Percentage of Subjects With Crude and PCR-corrected Cure Rate on Day 42	Day 42	Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations.	percentage of subjects	NUMBER

Source ClinicalTrials.gov

Results by group76

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

Outcome	Group	Category	Value	Units
Crude Cure Rate on Day 14	Pyronaridine Artesunate	Total cured	217	Participants
Crude Cure Rate on Day 14	Chloroquine	Total cured	209	Participants
Crude Cure Rate on Day 14	Pyronaridine Artesunate	Cambodia	75	Participants
Crude Cure Rate on Day 14	Chloroquine	Cambodia	73	Participants
Crude Cure Rate on Day 14	Pyronaridine Artesunate	India	33	Participants
Crude Cure Rate on Day 14	Chloroquine	India	33	Participants
Crude Cure Rate on Day 14	Pyronaridine Artesunate	Indonesia/Maumere	11	Participants
Crude Cure Rate on Day 14	Chloroquine	Indonesia/Maumere	10	Participants
Crude Cure Rate on Day 14	Pyronaridine Artesunate	Thailand/Mae Sot	49	Participants
Crude Cure Rate on Day 14	Chloroquine	Thailand/Mae Sot	46	Participants

1 to 10 of 76Source ClinicalTrials.gov

See all 76 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pyronaridine - Artesunate	228
Overall Study	STARTED	Chloroquine	228
Overall Study	COMPLETED	Pyronaridine - Artesunate	193
Overall Study	COMPLETED	Chloroquine	187
Overall Study	NOT COMPLETED	Pyronaridine - Artesunate	35
Overall Study	NOT COMPLETED	Chloroquine	41

Source ClinicalTrials.gov

Adverse events14

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	Events
other	Fatigue	General disorders	Pyronaridine Artesunate	12	228	12
other	Fatigue	General disorders	Chloroquine	11	228	11
other	Nasopharyngitis	Infections and infestations	Pyronaridine Artesunate	13	228	15
other	Nasopharyngitis	Infections and infestations	Chloroquine	6	228	7
other	Anorexia	Metabolism and nutrition disorders	Pyronaridine Artesunate	19	228	19
other	Anorexia	Metabolism and nutrition disorders	Chloroquine	10	228	10
other	Myalgia	Musculoskeletal and connective tissue disorders	Pyronaridine Artesunate	30	228	30
other	Myalgia	Musculoskeletal and connective tissue disorders	Chloroquine	21	228	22
other	Headache	Nervous system disorders	Pyronaridine Artesunate	45	228	52
other	Headache	Nervous system disorders	Chloroquine	34	228	40

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pyronaridine Artesunate	2	228
Total, all-cause mortality	Chloroquine	0	228
Total, other adverse events	Pyronaridine Artesunate	90	228
Total, other adverse events	Chloroquine	72	228
Total, serious adverse events	Pyronaridine Artesunate	2	228
Total, serious adverse events	Chloroquine	0	228

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21267072	RESULT	PubMed
23433102	DERIVED	PubMed
26666916	DERIVED	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 comparisons2

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

Comparison	Source
Pyronaridine Artesunate vs Chloroquine: deaths from any cause	Trial comparisons
Pyronaridine Artesunate vs Chloroquine: 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/NCT00440999

GET https://conductscience.org/api/trials/v1/NCT00440999/results?page=2

API reference For AI assistants