Therapeutic efficacy of artemether-lumefantrine (Coartem®) in treating uncomplicated P. falciparum malaria in Metehara, Eastern Ethiopia: regulatory clinical study

Nega, Desalegn, Assefa, Ashenafi, Mohamed, Hussein, Solomon, Hiwot, Woyessa, Adugna, Assefa, Yibeltal, Kebede, Amha and Kassa, Moges (2016) Therapeutic efficacy of artemether-lumefantrine (Coartem®) in treating uncomplicated P. falciparum malaria in Metehara, Eastern Ethiopia: regulatory clinical study. PLoS One, 11 4: . doi:10.1371/journal.pone.0154618


Author Nega, Desalegn
Assefa, Ashenafi
Mohamed, Hussein
Solomon, Hiwot
Woyessa, Adugna
Assefa, Yibeltal
Kebede, Amha
Kassa, Moges
Title Therapeutic efficacy of artemether-lumefantrine (Coartem®) in treating uncomplicated P. falciparum malaria in Metehara, Eastern Ethiopia: regulatory clinical study
Formatted title
Therapeutic efficacy of artemether-lumefantrine (Coartem®) in treating uncomplicated P. falciparum malaria in Metehara, Eastern Ethiopia: regulatory clinical study
Journal name PLoS One   Check publisher's open access policy
ISSN 1932-6203
Publication date 2016-04-29
Sub-type Article (original research)
DOI 10.1371/journal.pone.0154618
Open Access Status DOI
Volume 11
Issue 4
Total pages 14
Place of publication San Francisco, CA, United States
Publisher Public Library of Science
Collection year 2017
Language eng
Formatted abstract
Background: As per the WHO recommendation, the development of resistance by P. falciparum to most artemisinin combination therapies (ACTs) triggered the need for routine monitoring of the efficacy of the drugs every two years in all malaria endemic countries. Hence, this study was carried out to assess the therapeutic efficacy of Artemether-Lumefantrine (Coartem®) in treating the uncomplicated falciparum malaria, after 9 years of its introduction in the Metehara, Eastern Ethiopia.

Method: This is part of the therapeutic efficacy studies by the Federal Ministry of Health Ethiopia, which were conducted in regionally representative sentinel sites in the country from October 2014 to January 2015. Based on the study criteria set by WHO, febrile and malaria suspected outpatients in the health center were consecutively recruited to study. A standard six-dose regimen of AL was administered over three days and followed up for measuring therapeutic responses over 28 days. Data entry and analysis was done by using the WHO designed Excel spreadsheet and SPSS version 20 for Windows. Statistical significant was considered for P-value less than 0.05.

Result: Of the 91 patients enrolled, the day-28 analysis showed 83 adequate clinical and parasitological responses (ACPRs). Per protocol analysis, PCR-uncorrected & corrected cure rates of Coartem® among the study participants were 97.6% (95%CI: 93.6-99.5) and 98.8% (CI: 93.5-100%), respectively. No parasite detected on day 3 and onwards. Fever clearance was above 91% on day-3. Mean hemoglobin was significantly increased (P<0.000) from 12.39 g/dl at day 0 to 13.45 g/dl on day 28. No serious adverse drug reactions were observed among the study participants.

Conclusion: This study showed high efficacy of AL in the study area, which suggests the continuation of AL as first line drug for the treatment of uncomplicated P. falciparum malaria in the study area. This study recommends further studies on drug toxicity, particularly on repeated cough and oral ulceration.
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Public Health Publications
 
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