Trial · NCT04368910
Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
NCT04368910, Phase 3, Terminated, Medicines for Malaria Venture; results first posted 2022-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria. Trials, record NCT04368910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04368910
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
- NCT number
- NCT04368910
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Medicines for Malaria Venture
- Conditions
- Malaria
- Interventions
- Pyronaridine - artesunate, Chloroquine
- First posted
- 2020-04-30
- Last updated
- 2022-01-26
- Results first posted
- 2022-01-26
- Limitations and caveats
- Due to slow recruitment the study was terminated prematurely by the Sponsor after 30 subjects (of the 40 planned) had been included.
Source ClinicalTrials.gov
Registered outcomes8
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 | Percentage of subjects with crude cure rate at Day 14, defined as absence of parasitaemia on Day 14, irrespective of body temperature without previously meeting any of the criteria of treatment failure |
| Secondary | Crude Cure Rate on Day 28 | Day 28 | Percentage of subjects with crude cure rate at Day 28, defined as absence of parasitaemia on Day 28, irrespective of body temperature without previously meeting any of the criteria of treatment failure |
| Secondary | Parasite Clearance Time (PCT) | Days 0, 3, 7, 14, 21, 28, 35, and 42 (or on any other day if the subject spontaneously returned within the 42-day 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 (FCT) | 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 (Days 7, 14, 28 and 42) | 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 | Percentage of Patients Who Had Cleared Parasite on Days 1, 2, and 3 | Days 1, 2, and 3 | Parasite clearance is defined as at least 2 consecutive negative smears for asexual parasites obtained within an interval of 7 to 25 hours post-dosing |
| Secondary | Percentage of Patients Who Had Cleared Fever on Days 1, 2, and 3 | Days 1, 2, and 3 | Fever clearance is defined as at least 2 consecutive normal body temperature measurements (\<37.5 C axillary/tympanic or \<38.0 C oral/rectal) obtained within an interval of 7 to 25 hours postdosing |
| Secondary | Number of Participants With 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 | Number of Participants with AEs, including clinically significant laboratory results, electrocardiogram (ECG), vital signs or physical examination abnormalities |
| Other | Crude Cure Rate on Day 42 | Day 42 | Proportion of subjects with crude cure rate at Day 42, defined as absence of parasitaemia on Day 42, irrespective of body temperature without previously meeting any of the criteria of treatment failure |
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 | 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. | percentage of participants | NUMBER |
| SECONDARY | Crude Cure Rate on Day 28 | Day 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 participants | NUMBER |
| SECONDARY | Parasite Clearance Time (PCT) | Days 0, 3, 7, 14, 21, 28, 35, and 42 (or on any other day if the subject spontaneously returned within the 42-day period) | 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 (FCT) | 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 (Days 7, 14, 28 and 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 Patients Who Had Cleared Parasite 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 participants | NUMBER |
| SECONDARY | Percentage of Patients Who Had Cleared Fever 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 participants | NUMBER |
| SECONDARY | Number of Participants With 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 | Safety population, consisting of all randomised subjects who received any amount of study medication; subjects were analysed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Crude 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 group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Crude Cure Rate on Day 14 | Pyronaridine - Artesunate | 100 | 95% Confidence Interval 75.3 to 100.0 | percentage of participants | |
| Crude Cure Rate on Day 14 | Chloroquine | 100 | 95% Confidence Interval 78.2 to 100.0 | percentage of participants | |
| Crude Cure Rate on Day 28 | Pyronaridine - Artesunate | 100 | 95% Confidence Interval 75.3 to 100.0 | percentage of participants | |
| Crude Cure Rate on Day 28 | Chloroquine | 100 | 95% Confidence Interval 78.2 to 100.0 | percentage of participants | |
| Parasite Clearance Time (PCT) | Pyronaridine - Artesunate | 32.0 | 95% Confidence Interval 24.0 to 40.0 | hours | |
| Parasite Clearance Time (PCT) | Chloroquine | 63.9 | 95% Confidence Interval 55.9 to 160.8 | hours | |
| Fever Clearance Time (FCT) | Pyronaridine - Artesunate | 16.0 | 95% Confidence Interval 15.9 to 24.0 | hours | |
| Fever Clearance Time (FCT) | Chloroquine | 31.9 | 95% Confidence Interval 23.5 to 39.8 | hours | |
| Percentage of Patients Who Had Cleared Parasite on Days 1, 2, and 3 | Pyronaridine - Artesunate | Day 1 (24h after first dose) | 30.8 | 95% Confidence Interval 5.7 to 55.9 | percentage of participants |
| Percentage of Patients Who Had Cleared Parasite on Days 1, 2, and 3 | Chloroquine | Day 1 (24h after first dose) | 0.0 | 95% Confidence Interval 0.0 to 0.0 | percentage of participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 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 | 15 | |
| Overall Study | STARTED | Chloroquine | 15 | |
| Overall Study | COMPLETED | Pyronaridine - Artesunate | 15 | |
| Overall Study | COMPLETED | Chloroquine | 15 | |
| Overall Study | NOT COMPLETED | Pyronaridine - Artesunate | 0 | |
| Overall Study | NOT COMPLETED | Chloroquine | 0 |
Source ClinicalTrials.gov
Adverse events54
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 | Anemia | Blood and lymphatic system disorders | Pyronaridine - Artesunate | 1 | 15 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Chloroquine | 0 | 15 | 0 |
| other | Left ventricular hypertrophy | Cardiac disorders | Pyronaridine - Artesunate | 0 | 15 | 0 |
| other | Left ventricular hypertrophy | Cardiac disorders | Chloroquine | 1 | 15 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Pyronaridine - Artesunate | 1 | 15 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Chloroquine | 0 | 15 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Pyronaridine - Artesunate | 1 | 15 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Chloroquine | 1 | 15 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Pyronaridine - Artesunate | 1 | 15 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Chloroquine | 0 | 15 | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pyronaridine - Artesunate | 0 | 15 |
| Total, all-cause mortality | Chloroquine | 0 | 15 |
| Total, other adverse events | Pyronaridine - Artesunate | 10 | 15 |
| Total, other adverse events | Chloroquine | 10 | 15 |
| Total, serious adverse events | Pyronaridine - Artesunate | 0 | 15 |
| Total, serious adverse events | Chloroquine | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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