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Assessment of therapeutic efficacy and safety of artemether-lumefantrine (Coartem®) in the treatment of uncomplicated Plasmodium falciparum malaria patients in Bahir Dar district, Northwest Ethiopia: an observational cohort study.

Ebstie YA, Zeynudin A, Belachew T, Desalegn Z, Suleman S - Malar. J. (2015)

Bottom Line: At the end of the study, 98.5% of participants showed adequate clinical and parasitological response of the drug.In the study, only 1.5% of participants were shown late parasitological failure between seventh and 14th day follow-up and 1.3% of participants were free from anaemia at the end of follow-up.Outputs from this study should be supported through advanced molecular techniques and blood concentration and pharmaco-vigilance of the drug.

View Article: PubMed Central - PubMed

Affiliation: School of Medicine, Addis Ababa University, PO Box 9086, Addis Ababa, Ethiopia. yeh_kiam@yahoo.com.

ABSTRACT

Background: Malaria is a complex disease, which varies in its epidemiology and clinical manifestation. Although artemether-lumefantrine has been used as first-line drug for uncomplicated Plasmodium falciparum malaria in Bahir Dar district since 2004, its efficacy has not yet been assessed. The main objective of this study was to quantify the proportion of patients with uncomplicated falciparum malaria who were prescribed artemether-lumefantrine and who failed treatment after a 28-day follow-up.

Methods: The research team attempted to conduct an observational cohort study on the assessment of therapeutic efficacy and safety of artemether-lumefantrine in falciparum malaria patients aged over five years in Bahir Dar district from March to July 2012.

Results: Among 130 participants in the study, 60% were males with 1:5 male to female ratio. The mean of asexual parasitaemia load was 8675 parasites/μL and 96.1% participants were free from parasitaemia at day 3. At the end of the study, 98.5% of participants showed adequate clinical and parasitological response of the drug. In the study, only 1.5% of participants were shown late parasitological failure between seventh and 14th day follow-up and 1.3% of participants were free from anaemia at the end of follow-up.

Conclusion: According to the research findings, artemether-lumefantrine fulfilled the inclusion criteria of WHO as first-line drug and continues to be the drug of choice for the treatment of uncomplicated falciparum malaria. Outputs from this study should be supported through advanced molecular techniques and blood concentration and pharmaco-vigilance of the drug.

No MeSH data available.


Related in: MedlinePlus

Details on study inclusion and follow up progress Bahir Dar district, March to July 2012. Among 778 malaria suspected and screened individuals, 134 P.f. mono-infected participants considered as eligible study subjects. Of them, 4 individuals excluded from the study and 130 study participants finished and drug efficacy and safety outcomes were drawn
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Fig1: Details on study inclusion and follow up progress Bahir Dar district, March to July 2012. Among 778 malaria suspected and screened individuals, 134 P.f. mono-infected participants considered as eligible study subjects. Of them, 4 individuals excluded from the study and 130 study participants finished and drug efficacy and safety outcomes were drawn

Mentions: Finally, 134 eligible patients enrolled in the study. As Fig. 1 shows, two were excluded (one took anti-malarial drug and another denied to participate). On day 7, 132 slides from patients were examined and one person was found to be P. falciparum positive and excluded as treatment failure and treated with quinine. On day 14, 131 slides were examined and three were found positive: one for P. falciparum and excluded as a treatment failure after treated with chloroquine, the second and third participants were positive for P. vivax and tuberculosis and excluded from the study. Slides from the remaining 128 patients were examined for Day 21 and 28.Fig. 1


Assessment of therapeutic efficacy and safety of artemether-lumefantrine (Coartem®) in the treatment of uncomplicated Plasmodium falciparum malaria patients in Bahir Dar district, Northwest Ethiopia: an observational cohort study.

Ebstie YA, Zeynudin A, Belachew T, Desalegn Z, Suleman S - Malar. J. (2015)

Details on study inclusion and follow up progress Bahir Dar district, March to July 2012. Among 778 malaria suspected and screened individuals, 134 P.f. mono-infected participants considered as eligible study subjects. Of them, 4 individuals excluded from the study and 130 study participants finished and drug efficacy and safety outcomes were drawn
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4464854&req=5

Fig1: Details on study inclusion and follow up progress Bahir Dar district, March to July 2012. Among 778 malaria suspected and screened individuals, 134 P.f. mono-infected participants considered as eligible study subjects. Of them, 4 individuals excluded from the study and 130 study participants finished and drug efficacy and safety outcomes were drawn
Mentions: Finally, 134 eligible patients enrolled in the study. As Fig. 1 shows, two were excluded (one took anti-malarial drug and another denied to participate). On day 7, 132 slides from patients were examined and one person was found to be P. falciparum positive and excluded as treatment failure and treated with quinine. On day 14, 131 slides were examined and three were found positive: one for P. falciparum and excluded as a treatment failure after treated with chloroquine, the second and third participants were positive for P. vivax and tuberculosis and excluded from the study. Slides from the remaining 128 patients were examined for Day 21 and 28.Fig. 1

Bottom Line: At the end of the study, 98.5% of participants showed adequate clinical and parasitological response of the drug.In the study, only 1.5% of participants were shown late parasitological failure between seventh and 14th day follow-up and 1.3% of participants were free from anaemia at the end of follow-up.Outputs from this study should be supported through advanced molecular techniques and blood concentration and pharmaco-vigilance of the drug.

View Article: PubMed Central - PubMed

Affiliation: School of Medicine, Addis Ababa University, PO Box 9086, Addis Ababa, Ethiopia. yeh_kiam@yahoo.com.

ABSTRACT

Background: Malaria is a complex disease, which varies in its epidemiology and clinical manifestation. Although artemether-lumefantrine has been used as first-line drug for uncomplicated Plasmodium falciparum malaria in Bahir Dar district since 2004, its efficacy has not yet been assessed. The main objective of this study was to quantify the proportion of patients with uncomplicated falciparum malaria who were prescribed artemether-lumefantrine and who failed treatment after a 28-day follow-up.

Methods: The research team attempted to conduct an observational cohort study on the assessment of therapeutic efficacy and safety of artemether-lumefantrine in falciparum malaria patients aged over five years in Bahir Dar district from March to July 2012.

Results: Among 130 participants in the study, 60% were males with 1:5 male to female ratio. The mean of asexual parasitaemia load was 8675 parasites/μL and 96.1% participants were free from parasitaemia at day 3. At the end of the study, 98.5% of participants showed adequate clinical and parasitological response of the drug. In the study, only 1.5% of participants were shown late parasitological failure between seventh and 14th day follow-up and 1.3% of participants were free from anaemia at the end of follow-up.

Conclusion: According to the research findings, artemether-lumefantrine fulfilled the inclusion criteria of WHO as first-line drug and continues to be the drug of choice for the treatment of uncomplicated falciparum malaria. Outputs from this study should be supported through advanced molecular techniques and blood concentration and pharmaco-vigilance of the drug.

No MeSH data available.


Related in: MedlinePlus