Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria on Chloroquine and Primaquine Therapy|
- Chloroquine efficacy for P.vivax infections in Bhutan. [ Time Frame: 28 days ] [ Designated as safety issue: No ]The purpose is to study the efficacy of Chloroquine alone by recording recrudescent rates and parasitic clearance in P.vivax patients who are given a standard dose of Chloroquine treatment.
- To study the efficacy of Primaquine. [ Time Frame: Patients with recurrence after day 28 will be recorded. ] [ Designated as safety issue: Yes ]In this study, Primaquine will be administered on day 28, and any relapse will be recorded to study relapse rates over a 12 month period.
- To assess the feasibility of a 12 month follow-up of patients with vivax malaria in Bhutan. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To assess the safety of the currently prescribed CQ and PQ regimens in Bhutan. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Chloroquine and Primaquine
Chloroquine (CQ)10mg/kg for day 1, 2 and 5mg/kg for day 3 Primaquine (PQ)0.25mg/kg/day for 14 days
|Drug: Chloroquine Drug: Primaquine|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716260
|Contact: Dr Lorenz von Seidlein, MD||+61 8 8922 6998|
|Vector Diseases Control Program||Recruiting|
|Contact: Dr Yeshey Dorjey, MD|
|Contact: Dr Kinley Penjor, MD|
|Sub-Investigator: Dr Yeshey Dorjey|
|Sub-Investigator: Dr Kinley Penjor|
|Sub-Investigator: Dr Tashi Peldon|
|Principal Investigator: Mr Tobgay Tobgay|
|Sub-Investigator: Dr Lorenz von Seidlein|