NCT01716260

Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan

Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria on Chloroquine and Primaquine Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Menzies School of Health Research · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone. This study will assess whether CQ is still effective against P.vivax or whether there are resistant P.vivax strains in Bhutan.

Detailed description

This study aims to assess the efficacy of Chloroquine alone, withholding Primaquine until day 28. Parasitic clearance and recurrence rates will be recorded. Patients whose blood stage of parasites are not cleared with the standard dose of Chloroquine, or any recurrences before day 28, will be treated with second line treatment (ACT). The patients blood level of Chloroquine (drug concentration) at the time of a recrudescent infection will de determined to assess whether that could be due to resistance, or due to low level of Chloroquine. Any relapses occurring after day 28 when not receiving Primaquine, or after completion of Primaquine dosage for a total of 14 days (from day 29 to 42), will be treated with repeat doses of the initial treatment. The recurrence rates will be recorded so as to develop the next phase of the study where the two different doses of Primaquine (high dose vs. low dose) will be compared.

Conditions

• Vivax Malaria

Interventions

Type	Name	Description
DRUG	Chloroquine
DRUG	Primaquine

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-10-29
• Last updated: 2016-05-27

Locations

1 site across 1 country: Bhutan