Trial · NCT00403260
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
NCT00403260, Phase 3, Completed, Medicines for Malaria Venture; results first posted 2021-09-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients. Trials, record NCT00403260. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00403260
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
- NCT number
- NCT00403260
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,271 participants, actual
- Lead sponsor
- Medicines for Malaria Venture
- Conditions
- Falciparum Malaria
- Interventions
- Pyronaridine - artesunate, Mefloquine plus artesunate
- First posted
- 2006-11-23
- Last updated
- 2021-11-02
- Results first posted
- 2021-09-17
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 Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) 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 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 on Days 14 and 28 | Days 14 and 28 | Percentage of subjects with adequate clinical and parasitological response (ACPR) on Days 14 and 28, without correction by PCR, defined as absence of parasitaemia on Days 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 | Thick blood films were examined every 8 hours until ≥72 hours or until 2 consecutive negative readings occurred 7 to 25 hours apart, and on Days 3, 7, 14, 21, 28, 35, and 42 (or any other day if the subject returned). | Parasite clearance time was defined as the time from first dosing to 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 | Every 8 hours over ≥72 hours following first study drug administration or temperature normalisation for ≥2 readings between 7 and 25 hours apart, then at each visit. | Fever clearance time was defined as the time from first dosing to first normal reading of temperature (\<37.5°C taken axillary or tympanic; \<38°C taken oral or rectal) for 2 consecutive normal temperature readings taken between 7 and 25 hours apart. |
| Secondary | Parasite Clearance at Day 1, 2 and 3 | Days 1, 2 and 3 | Parasite clearance time was 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 at Day 1, 2 and 3 | Days 1, 2 and 3 | Fever clearance time was defined as the time for at least 2 consecutive normal body temperature measurements (\<37.5°C axillary/tympanic or \<38.0°C oral/rectal) to be obtained within an interval of 7 to 25 hours post-dosing. |
| 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 | Cases and severity 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 | Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 | Day 28 | Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. 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, and did not have major protocol deviations. | percentage of subjects | NUMBER |
| SECONDARY | PCR-corrected ACPR on Day 14 | Day 14 | Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. 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, and did not have major protocol deviations. | percentage of subjects | MEAN |
| SECONDARY | Crude ACPR on Days 14 and 28 | Days 14 and 28 | Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. 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, and did not have major protocol deviations. | percentage of subjects | NUMBER |
| SECONDARY | Parasite Clearance Time | Thick blood films were examined every 8 hours until ≥72 hours or until 2 consecutive negative readings occurred 7 to 25 hours apart, and on Days 3, 7, 14, 21, 28, 35, and 42 (or any other day if the subject returned). | Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. 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, and did not have major protocol deviations. | hours | MEDIAN |
| SECONDARY | Fever Clearance Time | Every 8 hours over ≥72 hours following first study drug administration or temperature normalisation for ≥2 readings between 7 and 25 hours apart, then at each visit. | Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. 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, and did not have major protocol deviations. | hours | MEDIAN |
| SECONDARY | Parasite Clearance at Day 1, 2 and 3 | Days 1, 2 and 3 | Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. 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, and did not have major protocol deviations. | percentage of subjects | NUMBER |
| SECONDARY | Fever Clearance at Day 1, 2 and 3 | Days 1, 2 and 3 | Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. 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, 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 consisted of all randomised subjects who received any amount of study medication; subjects were analysed 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 Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 | Pyronaridine - Artesunate | 99.2 | 95% Confidence Interval 98.3 to 99.7 | percentage of subjects | |
| Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 | Mefloquine Plus Artesunate | 98.1 | 95% Confidence Interval 96.1 to 99.2 | percentage of subjects | |
| PCR-corrected ACPR on Day 14 | Pyronaridine - Artesunate | 99.9 | 95% Confidence Interval 99.3 to 100.0 | percentage of subjects | |
| PCR-corrected ACPR on Day 14 | Mefloquine Plus Artesunate | 99.5 | 95% Confidence Interval 98.0 to 99.9 | percentage of subjects | |
| Crude ACPR on Days 14 and 28 | Pyronaridine - Artesunate | Cure rate (%) on Day 14 | 99.9 | 95% Confidence Interval 99.3 to 100.0 | percentage of subjects |
| Crude ACPR on Days 14 and 28 | Mefloquine Plus Artesunate | Cure rate (%) on Day 14 | 99.5 | 95% Confidence Interval 98.0 to 99.9 | percentage of subjects |
| Crude ACPR on Days 14 and 28 | Pyronaridine - Artesunate | Cure rate (%) on Day 28 | 98.7 | 95% Confidence Interval 97.6 to 99.4 | percentage of subjects |
| Crude ACPR on Days 14 and 28 | Mefloquine Plus Artesunate | Cure rate (%) on Day 28 | 96.7 | 95% Confidence Interval 94.4 to 98.3 | percentage of subjects |
| Parasite Clearance Time | Pyronaridine - Artesunate | 31.7 | 95% Confidence Interval 31.4 to 31.8 | hours | |
| Parasite Clearance Time | Mefloquine Plus Artesunate | 32.0 | 95% Confidence Interval 31.8 to 36.8 | 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 | Pyronaridine - Artesunate | 848 | |
| Overall Study | STARTED | Mefloquine Plus Artesunate | 423 | |
| Overall Study | COMPLETED | Pyronaridine - Artesunate | 723 | |
| Overall Study | COMPLETED | Mefloquine Plus Artesunate | 357 | |
| Overall Study | NOT COMPLETED | Pyronaridine - Artesunate | 125 | |
| Overall Study | NOT COMPLETED | Mefloquine Plus Artesunate | 66 |
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 | Myalgia | Musculoskeletal and connective tissue disorders | Pyronaridine - Artesunate | 53 | 848 | 60 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Mefloquine Plus Artesunate | 19 | 423 | 20 |
| other | Dizziness | Nervous system disorders | Pyronaridine - Artesunate | 26 | 848 | 26 |
| other | Dizziness | Nervous system disorders | Mefloquine Plus Artesunate | 28 | 423 | 29 |
| other | Headache | Nervous system disorders | Pyronaridine - Artesunate | 101 | 848 | 120 |
| other | Headache | Nervous system disorders | Mefloquine Plus Artesunate | 44 | 423 | 48 |
| other | Anorexia | Metabolism and nutrition disorders | Pyronaridine - Artesunate | 39 | 848 | 41 |
| other | Anorexia | Metabolism and nutrition disorders | Mefloquine Plus Artesunate | 13 | 423 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Pyronaridine - Artesunate | 31 | 848 | 31 |
| other | Anaemia | Blood and lymphatic system disorders | Mefloquine Plus Artesunate | 17 | 423 | 17 |
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 | Pyronaridine - Artesunate | 0 | 848 |
| Total, all-cause mortality | Mefloquine Plus Artesunate | 0 | 423 |
| Total, other adverse events | Pyronaridine - Artesunate | 389 | 848 |
| Total, other adverse events | Mefloquine Plus Artesunate | 190 | 423 |
| Total, serious adverse events | Pyronaridine - Artesunate | 6 | 848 |
| Total, serious adverse events | Mefloquine Plus Artesunate | 3 | 423 |
Source ClinicalTrials.gov
Papers3
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 |
|---|---|
| Pyronaridine - Artesunate vs Mefloquine Plus Artesunate: deaths from any cause | Trial comparisons |
| Pyronaridine - Artesunate vs Mefloquine Plus Artesunate: 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/NCT00403260
GET https://conductscience.org/api/trials/v1/NCT00403260/results?page=2