A pilot randomized controlled trial to compare the effectiveness of two 14‑day primaquine regimens for the radical cure of vivax malaria in South India

Saravu, Kavitha and Tellapragada, Chaitanya and Umakanth, Shashikiran and Brahmarouphu, Gouthami and Navya Sree, KS and Jagadish, PC and Saadi, Abdul Vahab and Guddattu, Vasudeva and Satyamoorthy, K and Bhat, Krishnamurthy (2018) A pilot randomized controlled trial to compare the effectiveness of two 14‑day primaquine regimens for the radical cure of vivax malaria in South India. Malaria Journal, 17 (1). pp. 321-332. ISSN 1475-2875

[img] PDF
RMS - 00005007.pdf - Published Version
Restricted to Registered users only

Download (2MB) | Request a copy

Abstract

Background: Radical cure of Plasmodium vivax malaria requires treatment with a blood schizonticide and a hypnozoitocide (primaquine) to eradicate the dormant liver stages. There has been uncertainty about the operational effectiveness and optimum dosing of the currently recommended 14-day primaquine (PQ) course. Methods: A two centre, randomized, open-label, two arm study was conducted in South India. Patients were randomized to receive either high dose (0.5 mg base/kg body weight) or conventional dose (0.25 mg/kg) PQ for 14 days. Plasma concentrations of PQ and carboxyprimaquine (CPQ) on the 7th day of treatment were measured by reverse phase high performance liquid chromatography. Study subjects were followed up for 6 months. Recurrent infections were genotyped using capillary fragment length polymorphism of two PCR-amplified microsatellite markers (MS07 and MS 10). Results: Fifty patients were enrolled. Baseline characteristics and laboratory features did not differ significantly between the groups. Mean age of the study population was 42 ± 16.0 years. Recurrences 80–105 days later occurred in 4 (8%) patients, two in each the groups. All recurrences had the same microsatellite genotype as that causing the index infection suggesting all were relapses. One relapse was associated with low CPQ concentrations suggesting poor adherence. Conclusions: This small pilot trial supports the effectiveness of the currently recommended lower dose (0.25 mg/kg/ day) 14 day PQ regimen for the radical cure of vivax malaria in South India.

Item Type: Article
Uncontrolled Keywords: Plasmodium vivax; recurrent malaria; primaquine; carboxyprimaquine; relapse; RP-HPLC; India.
Subjects: Departments at MU > Manipal Centre for Virus Research
Departments at MU > Statistics
Life Sciences > MLSC Manipal
Medicine > KMC Manipal > Medicine
Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Pharmacy > MCOPS Manipal > Pharmacy Practice
Depositing User: KMC Library
Date Deposited: 25 Sep 2018 04:35
Last Modified: 25 Sep 2018 04:35
URI: http://eprints.manipal.edu/id/eprint/152004

Actions (login required)

View Item View Item