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. Trial registration Clinical Trials Registry-India, CTRI/2017/03/007999. Registered 3 March 2017, http://ctri.nic.in/Clinicaltrials/regtrial.php?modid=1&compid=19&EncHid=82755.86366.

Original languageEnglish
Article number321
JournalMalaria Journal
Volume17
Issue number1
DOIs
Publication statusPublished - 03-09-2018

Fingerprint

Primaquine
Vivax Malaria
India
Randomized Controlled Trials
Recurrence
Microsatellite Repeats
Antiprotozoal Agents
Reverse-Phase Chromatography
Infection
Uncertainty
Registries
Genotype
High Pressure Liquid Chromatography
Body Weight
Clinical Trials
Polymerase Chain Reaction
Liver
Therapeutics
Population

All Science Journal Classification (ASJC) codes

  • Parasitology
  • Infectious Diseases

Cite this

@article{5da5a70036a74c1aaae0ee1e1c8e4c9e,
title = "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 CTRI/2017/03/007999 CTRI",
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. Trial registration Clinical Trials Registry-India, CTRI/2017/03/007999. Registered 3 March 2017, http://ctri.nic.in/Clinicaltrials/regtrial.php?modid=1&compid=19&EncHid=82755.86366.",
author = "Kavitha Saravu and Chaitanya Tellapragada and Shrivathsa Kulavalli and Wilbin Xavier and Shashikiran Umakanth and Gouthami Brahmarouphu and Srinivas, {Navyasree Kola} and Channabasavaiah, {Jagadish Puralae} and Anzil Bava and Saadi, {Abdul Vahab} and Vasudev Guddattu and Kapaettu Satyamoorthy and Krishnamurthy Bhat",
year = "2018",
month = "9",
day = "3",
doi = "10.1186/s12936-018-2472-5",
language = "English",
volume = "17",
journal = "Malaria Journal",
issn = "1475-2875",
publisher = "BioMed Central",
number = "1",

}

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 CTRI/2017/03/007999 CTRI. / Saravu, Kavitha; Tellapragada, Chaitanya; Kulavalli, Shrivathsa; Xavier, Wilbin; Umakanth, Shashikiran; Brahmarouphu, Gouthami; Srinivas, Navyasree Kola; Channabasavaiah, Jagadish Puralae; Bava, Anzil; Saadi, Abdul Vahab; Guddattu, Vasudev; Satyamoorthy, Kapaettu; Bhat, Krishnamurthy.

In: Malaria Journal, Vol. 17, No. 1, 321, 03.09.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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 CTRI/2017/03/007999 CTRI

AU - Saravu, Kavitha

AU - Tellapragada, Chaitanya

AU - Kulavalli, Shrivathsa

AU - Xavier, Wilbin

AU - Umakanth, Shashikiran

AU - Brahmarouphu, Gouthami

AU - Srinivas, Navyasree Kola

AU - Channabasavaiah, Jagadish Puralae

AU - Bava, Anzil

AU - Saadi, Abdul Vahab

AU - Guddattu, Vasudev

AU - Satyamoorthy, Kapaettu

AU - Bhat, Krishnamurthy

PY - 2018/9/3

Y1 - 2018/9/3

N2 - 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. Trial registration Clinical Trials Registry-India, CTRI/2017/03/007999. Registered 3 March 2017, http://ctri.nic.in/Clinicaltrials/regtrial.php?modid=1&compid=19&EncHid=82755.86366.

AB - 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. Trial registration Clinical Trials Registry-India, CTRI/2017/03/007999. Registered 3 March 2017, http://ctri.nic.in/Clinicaltrials/regtrial.php?modid=1&compid=19&EncHid=82755.86366.

UR - http://www.scopus.com/inward/record.url?scp=85052727184&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85052727184&partnerID=8YFLogxK

U2 - 10.1186/s12936-018-2472-5

DO - 10.1186/s12936-018-2472-5

M3 - Article

VL - 17

JO - Malaria Journal

JF - Malaria Journal

SN - 1475-2875

IS - 1

M1 - 321

ER -