Trial · NCT00541385
Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients
NCT00541385, Phase 3, Completed, Medicines for Malaria Venture; results first posted 2021-11-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients. Trials, record NCT00541385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00541385
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients
- NCT number
- NCT00541385
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 535 participants, actual
- Lead sponsor
- Medicines for Malaria Venture
- Conditions
- Malaria
- Interventions
- pyronaridine artesunate, arthemeter lumefantrine
- First posted
- 2007-10-10
- Last updated
- 2021-11-22
- Results first posted
- 2021-11-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With PCR-Corrected ACPR on Day 28 | Day 28 | Percentage of patients with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28. The PCR-corrected ACPR on Day 28 is defined as the absence of parasitaemia on Day 28 without the patient's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure |
| Secondary | Percentage of Participants With PCR-Corrected ACPR on Day 14 | Day 14 | Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 14. The PCR-corrected ACPR on Day 14 is defined as the 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) (Crude Cure Rate) on Day 14 and Day 28 | Days 14 and 28 | Percentage of subjects with adequate clinical and parasitological response (ACPR) on Day 14 and 28, without correction by PCR. Crude ACPR on Day 14 and 28 is defined as the absence of parasitaemia on Day 14 and 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 within the 42-day study period | 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 | 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 (within the 42-day study period) | Fever clearance time is defined as the time from first dosing to the first normal reading of temperature for 2 consecutive normal temperature readings taken between 7 and 25 hours apart. |
| Secondary | Proportion of Subjects With Cleared Parasites on Days 1, 2, and 3 | Days 1, 2, and 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 | Proportion of Subjects With Fever Cleared on Days 1, 2, and 3 | Days 1, 2, and 3 | Fever clearance time is defined as the time from first dosing to the first normal reading of temperature for 2 consecutive normal temperature readings taken between 7 and 25 hours apart |
| Secondary | Number of Subjects With ≥1 Adverse Event | 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 |
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 | Percentage of Participants With PCR-Corrected ACPR on Day 28 | Day 28 | Efficacy evaluable population: patients who completed a full course of study medication and had a known primary efficacy endpoint at D28; did not miss a dose; did not use concomitant medication, except acetaminophen; did not have a concomitant disease which may interfere with the clear classification of the treatment outcome; did not have a major protocol deviation.C | percentage of cured subjects | NUMBER |
| SECONDARY | Percentage of Participants With PCR-Corrected ACPR on Day 14 | Day 14 | Efficacy evaluable population: patients who completed a full course of study medication and had a known primary efficacy endpoint at D28; did not miss a dose; did not use concomitant medication, except acetaminophen; did not have a concomitant disease which may interfere with the clear classification of the treatment outcome; did not have a major protocol deviation. | percentage of subjects | NUMBER |
| SECONDARY | Crude ACPR (Non-PCR Corrected ACPR) (Crude Cure Rate) on Day 14 and Day 28 | Days 14 and 28 | Efficacy evaluable population: patients who completed a full course of study medication and had a known primary efficacy endpoint at D28; did not miss a dose; did not use concomitant medication, except acetaminophen; did not have a concomitant disease which may interfere with the clear classification of the treatment outcome; did not have a major protocol deviation. | 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 within the 42-day study period | Efficacy evaluable population: patients who completed a full course of study medication and had a known primary efficacy endpoint at D28; did not miss a dose; did not use concomitant medication, except acetaminophen; did not have a concomitant disease which may interfere with the clear classification of the treatment outcome; did not have a major protocol deviation. | 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 (within the 42-day study period) | Efficacy evaluable population\*: patients who completed a full course of study medication and had a known primary efficacy endpoint at D28; did not miss a dose; did not use concomitant medication, except acetaminophen; did not have a concomitant disease which may interfere with the clear classification of the treatment outcome; did not have a major protocol deviation.~\*does not include subjects initially included on history of fever. | hours | MEDIAN |
| SECONDARY | Proportion of Subjects With Cleared Parasites on Days 1, 2, and 3 | Days 1, 2, and 3 | Efficacy evaluable population: patients who completed a full course of study medication and had a known primary efficacy endpoint at D28; did not miss a dose; did not use concomitant medication, except acetaminophen; did not have a concomitant disease which may interfere with the clear classification of the treatment outcome; did not have a major protocol deviation. | percentage of subjects | NUMBER |
| SECONDARY | Proportion of Subjects With Fever Cleared on Days 1, 2, and 3 | Days 1, 2, and 3 | Efficacy evaluable population\*: patients who completed a full course of study medication and had a known primary efficacy endpoint at D28; did not miss a dose; did not use concomitant medication, except acetaminophen; did not have a concomitant disease which may interfere with the clear classification of the treatment outcome; did not have a major protocol deviation.~\*does not include subjects initially included on history of fever. | percentage of subjects | NUMBER |
| SECONDARY | Number of Subjects With ≥1 Adverse Event | 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: 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 |
|---|---|---|---|---|---|
| Percentage of Participants With PCR-Corrected ACPR on Day 28 | PA Group | 97.6 | 95% Confidence Interval 95.4 to 99.0 | percentage of cured subjects | |
| Percentage of Participants With PCR-Corrected ACPR on Day 28 | AL Group | 98.8 | 95% Confidence Interval 95.7 to 99.9 | percentage of cured subjects | |
| Percentage of Participants With PCR-Corrected ACPR on Day 14 | PA Group | 100.0 | 95% Confidence Interval 98.9 to 100.0 | percentage of subjects | |
| Percentage of Participants With PCR-Corrected ACPR on Day 14 | AL Group | 100.0 | 95% Confidence Interval 97.8 to 100.0 | percentage of subjects | |
| Crude ACPR (Non-PCR Corrected ACPR) (Crude Cure Rate) on Day 14 and Day 28 | PA Group | Percentage of Participants with ACPR at Day 14 | 100 | 95% Confidence Interval 98.9 to 100.0 | percentage of subjects |
| Crude ACPR (Non-PCR Corrected ACPR) (Crude Cure Rate) on Day 14 and Day 28 | AL Group | Percentage of Participants with ACPR at Day 14 | 100 | 95% Confidence Interval 97.8 to 100.0 | percentage of subjects |
| Crude ACPR (Non-PCR Corrected ACPR) (Crude Cure Rate) on Day 14 and Day 28 | PA Group | Percentage of Participants with ACPR at Day 28 | 90.2 | 95% Confidence Interval 86.5 to 93.2 | percentage of subjects |
| Crude ACPR (Non-PCR Corrected ACPR) (Crude Cure Rate) on Day 14 and Day 28 | AL Group | Percentage of Participants with ACPR at Day 28 | 89.2 | 95% Confidence Interval 83.5 to 93.5 | percentage of subjects |
| Parasite Clearance Time | PA Group | 24.1 | 95% Confidence Interval 24.0 to 24.1 | hours | |
| Parasite Clearance Time | AL Group | 24.2 | 95% Confidence Interval 24.0 to 31.8 | 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 | 355 | |
| Overall Study | STARTED | AL Group | 180 | |
| Overall Study | COMPLETED | PA Group | 274 | |
| Overall Study | COMPLETED | AL Group | 142 | |
| Overall Study | NOT COMPLETED | PA Group | 81 | |
| Overall Study | NOT COMPLETED | AL Group | 38 |
Source ClinicalTrials.gov
Adverse events58
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 | 34 | 355 | 36 |
| other | Anaemia | Blood and lymphatic system disorders | AL Group | 14 | 180 | 14 |
| other | Splenomegaly | Blood and lymphatic system disorders | PA Group | 8 | 355 | 8 |
| other | Splenomegaly | Blood and lymphatic system disorders | AL Group | 4 | 180 | 5 |
| other | Vomiting | Gastrointestinal disorders | PA Group | 25 | 355 | 27 |
| other | Vomiting | Gastrointestinal disorders | AL Group | 8 | 180 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | PA Group | 11 | 355 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | AL Group | 8 | 180 | 8 |
| other | Pyrexia | General disorders | PA Group | 23 | 355 | 24 |
| other | Pyrexia | General disorders | AL Group | 8 | 180 | 8 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PA Group | 0 | 355 |
| Total, all-cause mortality | AL Group | 0 | 180 |
| Total, other adverse events | PA Group | 285 | 355 |
| Total, other adverse events | AL Group | 143 | 180 |
| Total, serious adverse events | PA Group | 1 | 355 |
| Total, serious adverse events | AL Group | 0 | 180 |
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/NCT00541385
GET https://conductscience.org/api/trials/v1/NCT00541385/results?page=2