Trial Outcomes & Findings for Plasmodium Vivax Efficacy Trial in Cruzeiro do Sul, Acre, Brazil (NCT NCT02043652)

Results Overview

Investigators, according to WHO guidelines, will evaluate patients at regular intervals to evaluate symptom and parasitemia clearance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

119 participants

Primary outcome timeframe

28 days

Results posted on

2018-02-07

Participant milestones
Measure	Chloroquine and Primaquine Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm. Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm. Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.
Overall Study STARTED	119
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	26

Withdrawal data not reported

Plasmodium Vivax Efficacy Trial in Cruzeiro do Sul, Acre, Brazil

Baseline characteristics by cohort
Measure	Chlorquine and Primaquine n=119 Participants Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm. Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm. Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.
Age, Continuous	23.4 years n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants
Region of Enrollment Brazil	119 Participants n=5 Participants

Timeframe: 28 days

Investigators, according to WHO guidelines, will evaluate patients at regular intervals to evaluate symptom and parasitemia clearance.

Outcome measures
Measure	Chlorquine and Primaquine n=110 Participants Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm. Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm. Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.
Number of Patients With Adequate Clearance of Parasites and Symptoms	110 Participants

Timeframe: 6 months

Evaluate the relapse rate, that is reappearance of parasites, for up to 6 months after treatment.

Outcome measures
Measure	Chlorquine and Primaquine n=119 Participants Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm. Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm. Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.
Number of Patients Reporting Relapses	28 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

CDC

Phone: 404 718 4751