Trial · NCT00422084
Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients
NCT00422084, Phase 3, Completed, Medicines for Malaria Venture; results first posted 2021-09-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients. Trials, record NCT00422084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00422084
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients
- NCT number
- NCT00422084
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,272 participants, actual
- Lead sponsor
- Medicines for Malaria Venture
- Conditions
- Malaria
- Interventions
- Pyronaridine artesunate, Coartem® (artemether lumefantrine)
- First posted
- 2007-01-15
- Last updated
- 2021-11-02
- Results first posted
- 2021-09-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 | Day 28 | Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure. |
| Secondary | PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 14 | Day 14 | Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 14, defined as absence of parasitaemia on Day 14 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure. |
| Secondary | Crude ACPR (Non-PCR Corrected ACPR) on Day 14 and Day 28 | Day 14 and 28 | Percentage of subjects with adequate clinical and parasitological response (ACPR) on Day 28, without correction by PCR, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure. |
| Secondary | Parasite Clearance Time | Days 0, 3, 7, 14, 21, 28, 35, and 42 (or on any other day if the subject spontaneously returned) | 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 | Day 0 and every 8 hours over ≥72 hours following first study drug administration or temperature normalization for ≥2 readings between 7 and 25 hours apart, then at each visit and as clinically indicated | Fever clearance time is defined as the time from first dosing to first normal reading of temperature for 2 consecutive normal temperature readings taken between 7 and 25 hours apart |
| Secondary | Percentage of Patients With Fever Clearance at Day 1, 2 and 3 | Days 1, 2, 3 | Fever clearance time is defined as the time from first dosing to first normal reading of temperature for 2 consecutive normal temperature readings taken between 7 and 25 hours apart. |
| Secondary | Proportion of Patients With Parasite Clearance at Day 1, 2 and 3 | Days 1, 2, 3 | Parasite clearance time is defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart. |
| Secondary | Adverse Events and Clinically Significant Laboratory Results | 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 | Incidence of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 | Day 28 | Efficacy evaluable population subjects completed a full course of study medication; has a known primary efficacy endpoint at D28; did not miss a dose due to vomiting (except at D0); did not use a concomitant medication (except acetaminophen); did not have a concomitant disease which may have interfered with the classification of the treatment outcome; and did not have major protocol deviations. | percentage of subjects | NUMBER |
| SECONDARY | PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 14 | Day 14 | Efficacy evaluable population subjects completed a full course of study medication; has a known primary efficacy endpoint at D28; did not miss a dose due to vomiting (except at D0); did not use a concomitant medication (except acetaminophen); did not have a concomitant disease which may have interfered with the classification of the treatment outcome; and did not have major protocol deviations. | percentage of subjects | NUMBER |
| SECONDARY | Crude ACPR (Non-PCR Corrected ACPR) on Day 14 and Day 28 | Day 14 and 28 | Efficacy evaluable population subjects completed a full course of study medication; has a known primary efficacy endpoint at D28; did not miss a dose due to vomiting (except at D0); did not use a concomitant medication (except acetaminophen); did not have a concomitant disease which may have interfered with the classification of the treatment outcome; and did not have major protocol deviations. | percentage of subjects | NUMBER |
| SECONDARY | Parasite Clearance Time | Days 0, 3, 7, 14, 21, 28, 35, and 42 (or on any other day if the subject spontaneously returned) | Efficacy evaluable population subjects completed a full course of study medication; has a known primary efficacy endpoint at D28; did not miss a dose due to vomiting (except at D0); did not use a concomitant medication (except acetaminophen); did not have a concomitant disease which may have interfered with the classification of the treatment outcome; and did not have major protocol deviations. | hours | MEDIAN |
| SECONDARY | Fever Clearance Time | Day 0 and every 8 hours over ≥72 hours following first study drug administration or temperature normalization for ≥2 readings between 7 and 25 hours apart, then at each visit and as clinically indicated | Efficacy evaluable population subjects completed a full course of study medication; has a known primary efficacy endpoint at D28; did not miss a dose due to vomiting (except at D0); did not use a concomitant medication (except acetaminophen); did not have a concomitant disease which may have interfered with the classification of the treatment outcome; and did not have major protocol deviations. | hours | MEDIAN |
| SECONDARY | Percentage of Patients With Fever Clearance at Day 1, 2 and 3 | Days 1, 2, 3 | Efficacy evaluable population subjects completed a full course of study medication; has a known primary efficacy endpoint at D28; did not miss a dose due to vomiting (except at D0); did not use a concomitant medication (except acetaminophen); did not have a concomitant disease which may have interfered with the classification of the treatment outcome; and did not have major protocol deviations. | percentage of subjects | NUMBER |
| SECONDARY | Proportion of Patients With Parasite Clearance at Day 1, 2 and 3 | Days 1, 2, 3 | Efficacy evaluable population subjects completed a full course of study medication; has a known primary efficacy endpoint at D28; did not miss a dose due to vomiting (except at D0); did not use a concomitant medication (except acetaminophen); did not have a concomitant disease which may have interfered with the classification of the treatment outcome; and did not have major protocol deviations. | percentage of subjects | NUMBER |
| SECONDARY | Adverse Events and Clinically Significant Laboratory Results | 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 | The safety population consists of all randomized subjects who received any amount of study medication; subjects were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 | PA Group | 99.5 | 95% Confidence Interval 98.7 to 99.9 | percentage of subjects | |
| PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 | AL Group | 99.2 | 95% Confidence Interval 97.7 to 99.8 | percentage of subjects | |
| PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 14 | PA Group | 99.9 | 95% Confidence Interval 99.3 to 100.0 | percentage of subjects | |
| PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 14 | AL Group | 100 | 95% Confidence Interval 99.0 to 100.0 | percentage of subjects | |
| Crude ACPR (Non-PCR Corrected ACPR) on Day 14 and Day 28 | PA Group | Cure rate (%) at Day 14 | 100 | 95% Confidence Interval 99.5 to 100.0 | percentage of subjects |
| Crude ACPR (Non-PCR Corrected ACPR) on Day 14 and Day 28 | AL Group | Cure rate (%) at Day 14 | 100 | 95% Confidence Interval 99.0 to 100.0 | percentage of subjects |
| Crude ACPR (Non-PCR Corrected ACPR) on Day 14 and Day 28 | PA Group | Cure rate (%) at Day 28 | 98.9 | 95% Confidence Interval 97.8 to 99.5 | percentage of subjects |
| Crude ACPR (Non-PCR Corrected ACPR) on Day 14 and Day 28 | AL Group | Cure rate (%) at Day 28 | 97.2 | 95% Confidence Interval 95.0 to 98.6 | percentage of subjects |
| Parasite Clearance Time | PA Group | 23.9 | 95% Confidence Interval 23.9 to 23.9 | hours | |
| Parasite Clearance Time | AL Group | 24.0 | 95% Confidence Interval 23.9 to 24.1 | hours |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PA Group | 849 | |
| Overall Study | STARTED | AL Group | 423 | |
| Overall Study | COMPLETED | PA Group | 751 | |
| Overall Study | COMPLETED | AL Group | 347 | |
| Overall Study | NOT COMPLETED | PA Group | 98 | |
| Overall Study | NOT COMPLETED | AL Group | 76 |
Source ClinicalTrials.gov
Adverse events72
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 | Anaemia | Blood and lymphatic system disorders | PA Group | 17 | 849 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | AL Group | 4 | 423 | 4 |
| other | Eosinophilia | Blood and lymphatic system disorders | PA Group | 60 | 849 | 60 |
| other | Eosinophilia | Blood and lymphatic system disorders | AL Group | 26 | 423 | 26 |
| other | Lymphocytosis | Blood and lymphatic system disorders | PA Group | 21 | 849 | 23 |
| other | Lymphocytosis | Blood and lymphatic system disorders | AL Group | 16 | 423 | 17 |
| other | Neutropenia | Blood and lymphatic system disorders | PA Group | 41 | 849 | 45 |
| other | Neutropenia | Blood and lymphatic system disorders | AL Group | 27 | 423 | 27 |
| other | Bradycardia | Cardiac disorders | PA Group | 5 | 849 | 5 |
| other | Bradycardia | Cardiac disorders | AL Group | 5 | 423 | 5 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PA Group | 0 | 849 |
| Total, all-cause mortality | AL Group | 0 | 423 |
| Total, other adverse events | PA Group | 506 | 849 |
| Total, other adverse events | AL Group | 239 | 423 |
| Total, serious adverse events | PA Group | 3 | 849 |
| Total, serious adverse events | AL Group | 2 | 423 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| PA Group vs AL Group: deaths from any cause | Trial comparisons |
| PA Group vs AL Group: 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.
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/NCT00422084
GET https://conductscience.org/api/trials/v1/NCT00422084/results?page=2