Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine for Plasmodium Vivax Infection

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized open-label trial to evaluate the efficacy of chloroquine (CQ) alone compared to chloroquine+primaquine (CQ+PQ) in the treatment of uncomplicated malaria caused by Plasmodium vivax infection in a endemic area in the westernmost part of the Amazon Basin of Brazil. The duration of follow up for evaluating CQ efficacy as a schizonticidal drug was 28 days. The duration of complete follow up to detect recurrent P. vivax infections by passive surveillance was six months. All patients in the CQ alone arm received 7 days of PQ treatment (3.5mg/kg total dose) starting on day 28 of the study follow-up.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oswaldo Cruz Foundation
• Collaborator: University of Sao Paulo
• Treatments: Chloroquine; Chloroquine diphosphate; Primaquine

Criteria

Inclusion Criteria:

• Slide-confirmed mono-infection with P. vivax

• Age > 5 years

• Ability to swallow oral medication

• Axillary temperature ≥ 37.5º C or history of fever during the previous 48 hours

• Patient or caregiver agrees to comply with the study protocol (including blood collections and return visits) and provides written informed consent.

Exclusion Criteria:

• General danger signs or symptoms of severe malaria requiring hospitalization

• Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (NCHS/WHO normalized reference values)

• Slide-confirmed co-infection with any other Plasmodium species

• Severe anemia, defined as Hg<8g/100 ml

• Known hypersensitivity to any of the drugs being evaluated

• Presence of febrile conditions caused by diseases other than malaria

• Serious or chronic medical condition by history (cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)

• Pregnant or breastfeeding women

• Prior history of hemolysis or severe anemia

• Regular medication which may interfere with antimalarial pharmacokinetics