Trial Outcomes & Findings for Efficacy of 3 Regimens of Chloroquine and Primaquine for Treatment of P. Vivax Malaria, Cruzeiro do Sul, Acre, Brazil (NCT NCT03610399)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

257 participants

Primary outcome timeframe

28 days

Results posted on

2021-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Primaquine Regular Dose Unsupervised This is the regular primaquine dose (3.5 mg/kg) Brazil without directly observed therapy. Primaquine: Different total dose and supervision.	Primaquine Regular Dose Supervised This is the regular primaquine dose (3.5 mg/kg) in Brazil but with directly observed therapy. Primaquine: Different total dose and supervision.	Primaquine Double Dose Unsupervised This is the double total primaquine dose (14 days) (7.0 mg/kg) in Brazil with directly observed therapy. Primaquine: Different total dose and supervision.
Overall Study STARTED	63	96	95
Overall Study COMPLETED	53	78	79
Overall Study NOT COMPLETED	10	18	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primaquine Regular Dose Unsupervised n=63 Participants This is the regular primaquine dose (3.5 mg/kg) Brazil without directly observed therapy. Primaquine: Different total dose and supervision.	Primaquine Regular Dose Supervised n=96 Participants This is the regular primaquine dose (3.5 mg/kg) in Brazil but with directly observed therapy. Primaquine: Different total dose and supervision.	Primaquine Double Dose Unsupervised n=95 Participants This is the double total primaquine dose (14 days) (7.0 mg/kg) in Brazil with directly observed therapy. Primaquine: Different total dose and supervision.	Total n=254 Participants Total of all reporting groups
Age, Continuous	26.5 years n=63 Participants	20.3 years n=96 Participants	23.5 years n=95 Participants	22.4 years n=254 Participants
Sex: Female, Male Female	28 Participants n=63 Participants	44 Participants n=96 Participants	43 Participants n=95 Participants	115 Participants n=254 Participants
Sex: Female, Male Male	35 Participants n=63 Participants	52 Participants n=96 Participants	52 Participants n=95 Participants	139 Participants n=254 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Brazil	63 participants n=63 Participants	96 participants n=96 Participants	95 participants n=95 Participants	254 participants n=254 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Per-protocol uncorrected analysis.

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.

Outcome measures

Outcome measures
Measure	Primaquine Regular Dose Unsupervised n=63 Participants This is the regular primaquine dose (3.5 mg/kg) Brazil without directly observed therapy. Primaquine: Different total dose and supervision.	Primaquine Regular Dose Supervised n=89 Participants This is the regular primaquine dose (3.5 mg/kg) in Brazil but with directly observed therapy. Primaquine: Different total dose and supervision.	Primaquine Double Dose Unsupervised n=90 Participants This is the double total primaquine dose (14 days) (7.0 mg/kg) in Brazil with directly observed therapy. Primaquine: Different total dose and supervision.
Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled	61 participants	88 participants	90 participants

PRIMARY outcome

Timeframe: 168 days

Population: Per-protocol uncorrected analysis.

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.

Outcome measures

Outcome measures
Measure	Primaquine Regular Dose Unsupervised n=53 Participants This is the regular primaquine dose (3.5 mg/kg) Brazil without directly observed therapy. Primaquine: Different total dose and supervision.	Primaquine Regular Dose Supervised n=78 Participants This is the regular primaquine dose (3.5 mg/kg) in Brazil but with directly observed therapy. Primaquine: Different total dose and supervision.	Primaquine Double Dose Unsupervised n=79 Participants This is the double total primaquine dose (14 days) (7.0 mg/kg) in Brazil with directly observed therapy. Primaquine: Different total dose and supervision.
Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled	29 participants	44 participants	67 participants

SECONDARY outcome

Timeframe: 168 days

Population: 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 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.

Outcome measures

Outcome measures
Measure	Primaquine Regular Dose Unsupervised n=41 Participants This is the regular primaquine dose (3.5 mg/kg) Brazil without directly observed therapy. Primaquine: Different total dose and supervision.	Primaquine Regular Dose Supervised n=61 Participants This is the regular primaquine dose (3.5 mg/kg) in Brazil but with directly observed therapy. Primaquine: Different total dose and supervision.	Primaquine Double Dose Unsupervised n=71 Participants This is the double total primaquine dose (14 days) (7.0 mg/kg) in Brazil with directly observed therapy. Primaquine: Different total dose and supervision.
Participants With Adequate Clinical and Parasitologic Response Based on Microsatellite-corrected Analysis Per Protocol Day 168	29 Participants	44 Participants	67 Participants

Adverse Events

Primaquine Regular Dose Unsupervised

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Primaquine Regular Dose Supervised

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Primaquine Double Dose Unsupervised

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Suiane Negreiros

Acre Health State Secretariat

Phone: 55 68 9983 1266

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place