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
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 pr...
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ftdoajarticles:oai:doaj.org/article:1aeeb5465933440a8a1cb80a89f0af38 2023-05-15T15:11:49+02:00 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 Kavitha Saravu Chaitanya Tellapragada Shrivathsa Kulavalli Wilbin Xavier Shashikiran Umakanth Gouthami Brahmarouphu Navyasree Kola Srinivas Jagadish Puralae Channabasavaiah Anzil Bava Abdul Vahab Saadi Vasudev Guddattu Kapaettu Satyamoorthy Krishnamurthy Bhat 2018-09-01T00:00:00Z https://doi.org/10.1186/s12936-018-2472-5 https://doaj.org/article/1aeeb5465933440a8a1cb80a89f0af38 EN eng BMC http://link.springer.com/article/10.1186/s12936-018-2472-5 https://doaj.org/toc/1475-2875 doi:10.1186/s12936-018-2472-5 1475-2875 https://doaj.org/article/1aeeb5465933440a8a1cb80a89f0af38 Malaria Journal, Vol 17, Iss 1, Pp 1-11 (2018) Plasmodium vivax Recurrent malaria Primaquine Carboxyprimaquine Relapse RP-HPLC Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2018 ftdoajarticles https://doi.org/10.1186/s12936-018-2472-5 2022-12-31T10:17:11Z 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. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 17 1 |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
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English |
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Plasmodium vivax Recurrent malaria Primaquine Carboxyprimaquine Relapse RP-HPLC Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
spellingShingle |
Plasmodium vivax Recurrent malaria Primaquine Carboxyprimaquine Relapse RP-HPLC Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Kavitha Saravu Chaitanya Tellapragada Shrivathsa Kulavalli Wilbin Xavier Shashikiran Umakanth Gouthami Brahmarouphu Navyasree Kola Srinivas Jagadish Puralae Channabasavaiah Anzil Bava Abdul Vahab Saadi Vasudev Guddattu Kapaettu Satyamoorthy Krishnamurthy Bhat 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 |
topic_facet |
Plasmodium vivax Recurrent malaria Primaquine Carboxyprimaquine Relapse RP-HPLC Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
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. |
format |
Article in Journal/Newspaper |
author |
Kavitha Saravu Chaitanya Tellapragada Shrivathsa Kulavalli Wilbin Xavier Shashikiran Umakanth Gouthami Brahmarouphu Navyasree Kola Srinivas Jagadish Puralae Channabasavaiah Anzil Bava Abdul Vahab Saadi Vasudev Guddattu Kapaettu Satyamoorthy Krishnamurthy Bhat |
author_facet |
Kavitha Saravu Chaitanya Tellapragada Shrivathsa Kulavalli Wilbin Xavier Shashikiran Umakanth Gouthami Brahmarouphu Navyasree Kola Srinivas Jagadish Puralae Channabasavaiah Anzil Bava Abdul Vahab Saadi Vasudev Guddattu Kapaettu Satyamoorthy Krishnamurthy Bhat |
author_sort |
Kavitha Saravu |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
pilot randomized controlled trial to compare the effectiveness of two 14-day primaquine regimens for the radical cure of vivax malaria in south india |
publisher |
BMC |
publishDate |
2018 |
url |
https://doi.org/10.1186/s12936-018-2472-5 https://doaj.org/article/1aeeb5465933440a8a1cb80a89f0af38 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 17, Iss 1, Pp 1-11 (2018) |
op_relation |
http://link.springer.com/article/10.1186/s12936-018-2472-5 https://doaj.org/toc/1475-2875 doi:10.1186/s12936-018-2472-5 1475-2875 https://doaj.org/article/1aeeb5465933440a8a1cb80a89f0af38 |
op_doi |
https://doi.org/10.1186/s12936-018-2472-5 |
container_title |
Malaria Journal |
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17 |
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1 |
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1766342611886407680 |