Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia

Abstract Background In 2004, Ethiopia adopted artemether-lumefantrine (AL, Coartem®) as first-line treatment for the management of uncomplicated Plasmodium falciparum malaria. Continuous monitoring of AL therapeutic efficacy is crucial in Ethiopia, as per the World Health Organization (WHO) recommen...

Full description

Bibliographic Details
Main Authors: Kale Gubae, Hussein Mohammed, Heven Sime, Henok Hailgiorgis, Anteneh Kassahun Mare, Bokretsion Gidey, Mebrahtom Haile, Gudissa Assefa, Worku Bekele, Geremew Tasew, Solomon Mequanente Abay, Ashenafi Assefa
Format: Article
Language:English
Published: BMC 2023-01-01
Series:Malaria Journal
Subjects:
Online Access:https://doi.org/10.1186/s12936-022-04436-8
_version_ 1797958842236010496
author Kale Gubae
Hussein Mohammed
Heven Sime
Henok Hailgiorgis
Anteneh Kassahun Mare
Bokretsion Gidey
Mebrahtom Haile
Gudissa Assefa
Worku Bekele
Geremew Tasew
Solomon Mequanente Abay
Ashenafi Assefa
author_facet Kale Gubae
Hussein Mohammed
Heven Sime
Henok Hailgiorgis
Anteneh Kassahun Mare
Bokretsion Gidey
Mebrahtom Haile
Gudissa Assefa
Worku Bekele
Geremew Tasew
Solomon Mequanente Abay
Ashenafi Assefa
author_sort Kale Gubae
collection DOAJ
description Abstract Background In 2004, Ethiopia adopted artemether-lumefantrine (AL, Coartem®) as first-line treatment for the management of uncomplicated Plasmodium falciparum malaria. Continuous monitoring of AL therapeutic efficacy is crucial in Ethiopia, as per the World Health Organization (WHO) recommendation. This study aimed to assess the therapeutic efficacy of AL in the treatment of uncomplicated P. falciparum infection. Methods A 28 day onearm, prospective evaluation of the clinical and parasitological response to AL was conducted at Shecha Health Centre, Arba Minch town, Southern Ethiopia. Patients were treated with six-dose regimen of AL over three days and monitored for 28 days with clinical and laboratory assessments. Participant recruitment and outcome classification was done in accordance with the 2009 WHO methods for surveillance of anti-malarial drug efficacy guidelines. Results A total of 88 study participants were enrolled and 69 of them completed the study with adequate clinical and parasitological response. Two late parasitological failures were observed, of which one was classified as a recrudescence by polymerase chain reaction (PCR). The PCRcorrected cure rate was 98.6% (95% CI 92.3–100). AL demonstrated a rapid parasite and fever clearance with no parasitaemia on day 2 and febrile cases on day 3. Gametocyte clearance was complete by day three. No serious adverse events were reported during the 28 days follow-up. Conclusion The study demonstrated high therapeutic efficacy and good safety profile of AL. This suggests the continuation of AL as the first-line drug for the treatment of uncomplicated P. falciparum malaria in Ethiopia. Periodic therapeutic efficacy studies and monitoring of markers of resistance are recommended for early detection of resistant parasites.
first_indexed 2024-04-11T00:24:32Z
format Article
id doaj.art-e118163bd6ad4e5792a327cfede8f826
institution Directory Open Access Journal
issn 1475-2875
language English
last_indexed 2024-04-11T00:24:32Z
publishDate 2023-01-01
publisher BMC
record_format Article
series Malaria Journal
spelling doaj.art-e118163bd6ad4e5792a327cfede8f8262023-01-08T12:05:26ZengBMCMalaria Journal1475-28752023-01-0122111010.1186/s12936-022-04436-8Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, EthiopiaKale Gubae0Hussein Mohammed1Heven Sime2Henok Hailgiorgis3Anteneh Kassahun Mare4Bokretsion Gidey5Mebrahtom Haile6Gudissa Assefa7Worku Bekele8Geremew Tasew9Solomon Mequanente Abay10Ashenafi Assefa11Department of Pharmacy, College of Health Sciences, Debre Markos UniversityMalaria and Other Parasitological and Entomological Research Team, Bacterial, Parasitic and Zoonotic Diseases Research Directorate, Ethiopian Public Health InstituteMalaria and Other Parasitological and Entomological Research Team, Bacterial, Parasitic and Zoonotic Diseases Research Directorate, Ethiopian Public Health InstituteMalaria and Other Parasitological and Entomological Research Team, Bacterial, Parasitic and Zoonotic Diseases Research Directorate, Ethiopian Public Health InstituteDepartment of Pharmacology and Clinical Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa UniversityMalaria and Other Parasitological and Entomological Research Team, Bacterial, Parasitic and Zoonotic Diseases Research Directorate, Ethiopian Public Health InstituteEthiopian Ministry of HealthEthiopian Ministry of HealthWorld Health OrganizationMalaria and Other Parasitological and Entomological Research Team, Bacterial, Parasitic and Zoonotic Diseases Research Directorate, Ethiopian Public Health InstituteDepartment of Pharmacology and Clinical Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa UniversityMalaria and Other Parasitological and Entomological Research Team, Bacterial, Parasitic and Zoonotic Diseases Research Directorate, Ethiopian Public Health InstituteAbstract Background In 2004, Ethiopia adopted artemether-lumefantrine (AL, Coartem®) as first-line treatment for the management of uncomplicated Plasmodium falciparum malaria. Continuous monitoring of AL therapeutic efficacy is crucial in Ethiopia, as per the World Health Organization (WHO) recommendation. This study aimed to assess the therapeutic efficacy of AL in the treatment of uncomplicated P. falciparum infection. Methods A 28 day onearm, prospective evaluation of the clinical and parasitological response to AL was conducted at Shecha Health Centre, Arba Minch town, Southern Ethiopia. Patients were treated with six-dose regimen of AL over three days and monitored for 28 days with clinical and laboratory assessments. Participant recruitment and outcome classification was done in accordance with the 2009 WHO methods for surveillance of anti-malarial drug efficacy guidelines. Results A total of 88 study participants were enrolled and 69 of them completed the study with adequate clinical and parasitological response. Two late parasitological failures were observed, of which one was classified as a recrudescence by polymerase chain reaction (PCR). The PCRcorrected cure rate was 98.6% (95% CI 92.3–100). AL demonstrated a rapid parasite and fever clearance with no parasitaemia on day 2 and febrile cases on day 3. Gametocyte clearance was complete by day three. No serious adverse events were reported during the 28 days follow-up. Conclusion The study demonstrated high therapeutic efficacy and good safety profile of AL. This suggests the continuation of AL as the first-line drug for the treatment of uncomplicated P. falciparum malaria in Ethiopia. Periodic therapeutic efficacy studies and monitoring of markers of resistance are recommended for early detection of resistant parasites.https://doi.org/10.1186/s12936-022-04436-8Therapeutic efficacyArtemether-lumefantrineUncomplicated malariaEthiopia
spellingShingle Kale Gubae
Hussein Mohammed
Heven Sime
Henok Hailgiorgis
Anteneh Kassahun Mare
Bokretsion Gidey
Mebrahtom Haile
Gudissa Assefa
Worku Bekele
Geremew Tasew
Solomon Mequanente Abay
Ashenafi Assefa
Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
Malaria Journal
Therapeutic efficacy
Artemether-lumefantrine
Uncomplicated malaria
Ethiopia
title Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
title_full Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
title_fullStr Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
title_full_unstemmed Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
title_short Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
title_sort safety and therapeutic efficacy of artemether lumefantrine in the treatment of uncomplicated plasmodium falciparum malaria at shecha health centre arba minch ethiopia
topic Therapeutic efficacy
Artemether-lumefantrine
Uncomplicated malaria
Ethiopia
url https://doi.org/10.1186/s12936-022-04436-8
work_keys_str_mv AT kalegubae safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia
AT husseinmohammed safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia
AT hevensime safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia
AT henokhailgiorgis safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia
AT antenehkassahunmare safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia
AT bokretsiongidey safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia
AT mebrahtomhaile safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia
AT gudissaassefa safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia
AT workubekele safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia
AT geremewtasew safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia
AT solomonmequanenteabay safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia
AT ashenafiassefa safetyandtherapeuticefficacyofartemetherlumefantrineinthetreatmentofuncomplicatedplasmodiumfalciparummalariaatshechahealthcentrearbaminchethiopia