Trial · NCT03610399
Efficacy of 3 Regimens of Chloroquine and Primaquine for Treatment of P. Vivax Malaria, Cruzeiro do Sul, Acre, Brazil
NCT03610399, Not applicable, Completed, Centers for Disease Control and Prevention; results first posted 2021-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of 3 Regimens of Chloroquine and Primaquine for Treatment of P. Vivax Malaria, Cruzeiro do Sul, Acre, Brazil. Trials, record NCT03610399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03610399
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of 3 Regimens of Chloroquine and Primaquine for Treatment of P. Vivax Malaria, Cruzeiro do Sul, Acre, Brazil
- NCT number
- NCT03610399
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 257 participants, actual
- Lead sponsor
- Centers for Disease Control and Prevention
- Conditions
- P Vivax, Malaria, Vivax
- Interventions
- Primaquine
- First posted
- 2018-08-01
- Last updated
- 2021-08-09
- Results first posted
- 2021-08-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled | 28 days | Participants with adequate clinical and parasitologic response among patients enrolled, meaning patients who did not fail treatment by day 28. Those are participants who at day 28 did not present clinical deterioration or presence of parasitemia. |
| Primary | Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled | 168 days | Participants with adequate clinical and parasitologic response among patients enrolled, meaning patients who did not fail treatment by day 168. Those are participants who at day 168 did not present clinical deterioration or presence of parasitemia. |
| Secondary | Participants With Adequate Clinical and Parasitologic Response Based on Microsatellite-corrected Analysis Per Protocol Day 168 | 168 days | Participants with microsatellite-corrected adequate clinical and parasitologic response among patients enrolled, meaning patients who did not fail treatment by day 168. Those are participants who at day 168 did not present clinical deterioration or presence of parasitemia with homologous (same genotype) parasites. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled | 28 days | Per-protocol uncorrected analysis. | participants | NUMBER |
| PRIMARY | Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled | 168 days | Per-protocol uncorrected analysis. | participants | NUMBER |
| SECONDARY | Participants With Adequate Clinical and Parasitologic Response Based on Microsatellite-corrected Analysis Per Protocol Day 168 | 168 days | Microsatellite-corrected analysis excludes participants who, during follow-up, presented with heterologous infections (genotype different) or whose genotype could not be determined. This reduced the number of overall participants by 12 for the 'Primaquine Regular Dose Unsupervised' arm; 17 participants in the 'Primaquine Regular Dose Supervised' arm; and 8 participants in the 'Primaquine Double Dose Unsupervised' arm, in comparison to the totals in the Participant Flow section. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled | Primaquine Regular Dose Unsupervised | 61 | participants | ||
| Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled | Primaquine Regular Dose Supervised | 88 | participants | ||
| Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled | Primaquine Double Dose Unsupervised | 90 | participants | ||
| Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled | Primaquine Regular Dose Unsupervised | 29 | participants | ||
| Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled | Primaquine Regular Dose Supervised | 44 | participants | ||
| Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled | Primaquine Double Dose Unsupervised | 67 | participants | ||
| Participants With Adequate Clinical and Parasitologic Response Based on Microsatellite-corrected Analysis Per Protocol Day 168 | Primaquine Regular Dose Unsupervised | 29 | Participants | ||
| Participants With Adequate Clinical and Parasitologic Response Based on Microsatellite-corrected Analysis Per Protocol Day 168 | Primaquine Regular Dose Supervised | 44 | Participants | ||
| Participants With Adequate Clinical and Parasitologic Response Based on Microsatellite-corrected Analysis Per Protocol Day 168 | Primaquine Double Dose Unsupervised | 67 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Primaquine Regular Dose Unsupervised | 63 | |
| Overall Study | STARTED | Primaquine Regular Dose Supervised | 96 | |
| Overall Study | STARTED | Primaquine Double Dose Unsupervised | 95 | |
| Overall Study | COMPLETED | Primaquine Regular Dose Unsupervised | 53 | |
| Overall Study | COMPLETED | Primaquine Regular Dose Supervised | 78 | |
| Overall Study | COMPLETED | Primaquine Double Dose Unsupervised | 79 | |
| Overall Study | NOT COMPLETED | Primaquine Regular Dose Unsupervised | 10 | |
| Overall Study | NOT COMPLETED | Primaquine Regular Dose Supervised | 18 | |
| Overall Study | NOT COMPLETED | Primaquine Double Dose Unsupervised | 16 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Primaquine Regular Dose Unsupervised | 0 | 63 |
| Total, all-cause mortality | Primaquine Regular Dose Supervised | 0 | 96 |
| Total, all-cause mortality | Primaquine Double Dose Unsupervised | 0 | 95 |
| Total, other adverse events | Primaquine Regular Dose Unsupervised | 0 | 63 |
| Total, other adverse events | Primaquine Regular Dose Supervised | 0 | 96 |
| Total, other adverse events | Primaquine Double Dose Unsupervised | 0 | 95 |
| Total, serious adverse events | Primaquine Regular Dose Unsupervised | 0 | 63 |
| Total, serious adverse events | Primaquine Regular Dose Supervised | 0 | 96 |
| Total, serious adverse events | Primaquine Double Dose Unsupervised | 0 | 95 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35353962 | 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/NCT03610399
GET https://conductscience.org/api/trials/v1/NCT03610399/registered