Trial · NCT01594931
Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria
NCT01594931, Phase 2, 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. Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria. Trials, record NCT01594931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01594931
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria
- NCT number
- NCT01594931
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 477 participants, actual
- Lead sponsor
- Medicines for Malaria Venture
- Conditions
- Plasmodium Falciparum Malaria
- Interventions
- pyronaridine/artesunate
- First posted
- 2012-05-09
- Last updated
- 2021-11-02
- Results first posted
- 2021-09-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PCR-Corrected ACPR at 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 at 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 | Parasite Clearance Time | Thick blood slides were examined every 8 hours until at least 72 hours or until a negative smear was recorded | Parasite clearance time was defined as the time (in hours) from first dosing to the time of first blood draw with parasite clearance. Parasite clearance is defined as zero presence of parasites for two consecutive negative readings eight hours apart, with confirmed negative reading at 24 hours after the first negative slide |
| Secondary | Fever Clearance Time | Every 8 hours for at least 72 hours after the first dose | Fever clearance time was defined as the time (in hours) from first dosing to the first normal reading with fever clearance (2 consecutive assessments without fever (\<37.5°C)). The method of temperature measurement was the same (ie, axillary, tympanic, oral or rectal) for each subject. Any subjects with a documented history of fever at inclusion, but who did not subsequently have a documented temperature reading \>37.5°C during the 24 hours after initial dosing, were not included in this end point analysis. |
| Secondary | Parasite Clearance | Days 1, 2, and 3 | Parasite clearance is defined as zero presence of parasites for 2 consecutive negative readings 8 hours apart, with confirmed negative reading at 24 hours after the first negative slide. The proportion of subjects with parasite clearance was summarized at Days 1, 2, and 3. |
| Secondary | Fever Clearance | Days 1, 2 and 3 | Fever clearance was defined as a subject without fever for 2 consecutive assessments, plus confirmed normal temperature at 24 hours. The proportion of subjects with fever clearance was summarized at Days 1, 2, and 3. |
| Secondary | Adverse Events (AEs) | 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 | An AE was defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PCR-Corrected ACPR at Day 28 | Day 28 | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | percentage of subjects | NUMBER |
| SECONDARY | PCR-Corrected ACPR at Day 14 | Day 14 | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | percentage of subjects | NUMBER |
| SECONDARY | Parasite Clearance Time | Thick blood slides were examined every 8 hours until at least 72 hours or until a negative smear was recorded | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | hours | MEAN |
| SECONDARY | Fever Clearance Time | Every 8 hours for at least 72 hours after the first dose | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | hours | MEAN |
| SECONDARY | Parasite Clearance | Days 1, 2, and 3 | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | percentage of subjects | NUMBER |
| SECONDARY | Fever Clearance | Days 1, 2 and 3 | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | percentage of subjects | NUMBER |
| SECONDARY | Adverse Events (AEs) | 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 includes all subjects who were randomized and received any study medication, regardless of the amount. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| PCR-Corrected ACPR at Day 28 | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 95 | 90% Confidence Interval 89.9 to 98.0 | percentage of subjects | |
| PCR-Corrected ACPR at Day 28 | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 99 | 90% Confidence Interval 95.5 to 100.0 | percentage of subjects | |
| PCR-Corrected ACPR at Day 28 | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 99 | 90% Confidence Interval 95.4 to 99.9 | percentage of subjects | |
| PCR-Corrected ACPR at Day 14 | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 100 | 90% Confidence Interval 97.2 to 100.0 | percentage of subjects | |
| PCR-Corrected ACPR at Day 14 | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 100 | 90% Confidence Interval 97.2 to 100.0 | percentage of subjects | |
| PCR-Corrected ACPR at Day 14 | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 100 | 90% Confidence Interval 97.2 to 100.0 | percentage of subjects | |
| Parasite Clearance Time | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 36.9 | Standard Deviation 20.73 | hours | |
| Parasite Clearance Time | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 33.6 | Standard Deviation 17.08 | hours | |
| Parasite Clearance Time | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 30.8 | Standard Deviation 14.96 | hours | |
| Fever Clearance Time | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 16.8 | Standard Deviation 12.75 | hours |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 160 | |
| Overall Study | STARTED | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 157 | |
| Overall Study | STARTED | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 160 | |
| Overall Study | COMPLETED | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 131 | |
| Overall Study | COMPLETED | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 145 | |
| Overall Study | COMPLETED | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 146 | |
| Overall Study | NOT COMPLETED | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 29 | |
| Overall Study | NOT COMPLETED | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 12 | |
| Overall Study | NOT COMPLETED | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 14 |
Source ClinicalTrials.gov
Adverse events159
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 | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 16 | 160 | 16 |
| other | Anaemia | Blood and lymphatic system disorders | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 15 | 157 | 15 |
| other | Anaemia | Blood and lymphatic system disorders | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 13 | 159 | 13 |
| other | Eosinophilia | Blood and lymphatic system disorders | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 6 | 160 | 6 |
| other | Eosinophilia | Blood and lymphatic system disorders | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 7 | 157 | 7 |
| other | Eosinophilia | Blood and lymphatic system disorders | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 5 | 159 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 4 | 160 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 0 | 157 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 1 | 159 | 1 |
| other | Arrhythmia | Cardiac disorders | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 2 | 160 | 2 |
1 to 10 of 159Source ClinicalTrials.gov
See all 159 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 0 | 160 |
| Total, all-cause mortality | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 0 | 157 |
| Total, all-cause mortality | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 0 | 159 |
| Total, other adverse events | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 106 | 160 |
| Total, other adverse events | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 90 | 157 |
| Total, other adverse events | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 91 | 159 |
| Total, serious adverse events | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | 3 | 160 |
| Total, serious adverse events | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | 0 | 157 |
| Total, serious adverse events | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | 1 | 159 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23433102 | DERIVED |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01594931
GET https://conductscience.org/api/trials/v1/NCT01594931/results?page=2