Effectiveness and safety of artemether–lumefantrine versus artesunate–amodiaquine for unsupervised treatment of uncomplicated falciparum malaria in patients of all age groups in Nanoro, Burkina Faso: a randomized open label trial
| Autor: | Paul Sondo, Odile Zampa, Hermann Sorgho, Zekiba Tarnagda, Adama Kazienga, Halidou Tinto, Karim Derra, Seydou Diallo-Nakanabo, Ellis Owusu-Dabo, Innocent Valea, Jean-Bosco Ouédraogo, Tinga Robert Guiguemdé |
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| Jazyk: | angličtina |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Artemether/lumefantrine Unsupervised-treatment Effectiveness Kaplan-Meier Estimate Amodiaquine Artesunate–amodiaquine law.invention Antimalarials Randomized controlled trial Recurrence law Burkina Faso medicine Humans Artemether Malaria Falciparum Child Adverse effect Fluorenes business.industry Research Artemether Lumefantrine Drug Combination Artesunate/amodiaquine Infant Newborn Infant medicine.disease Artemisinins Malaria Clinical trial Drug Combinations Infectious Diseases Ethanolamines Child Preschool Female Parasitology Artemether–lumefantrine business medicine.drug |
| Zdroj: | Malaria Journal |
| ISSN: | 1475-2875 |
| DOI: | 10.1186/s12936-015-0843-8 |
| Popis: | Background Several studies have reported high efficacy and safety of artemisinin-based combination therapy (ACT) mostly under strict supervision of drug intake and limited to children less than 5 years of age. Patients over 5 years of age are usually not involved in such studies. Thus, the findings do not fully reflect the reality in the field. This study aimed to assess the effectiveness and safety of ACT in routine treatment of uncomplicated malaria among patients of all age groups in Nanoro, Burkina Faso. Methods A randomized open label trial comparing artesunate–amodiaquine (ASAQ) and artemether–lumefantrine (AL) was carried out from September 2010 to October 2012 at two primary health centres (Nanoro and Nazoanga) of Nanoro health district. A total of 680 patients were randomized to receive either ASAQ or AL without any distinction by age. Drug intake was not supervised as pertains in routine practice in the field. Patients or their parents/guardians were advised on the time and mode of administration for the 3 days treatment unobserved at home. Follow-up visits were performed on days 3, 7, 14, 21, and 28 to evaluate clinical and parasitological resolution of their malaria episode as well as adverse events. PCR genotyping of merozoite surface proteins 1 and 2 (msp-1, msp-2) was used to differentiate recrudescence and new infection. Results By day 28, the PCR corrected adequate clinical and parasitological response was 84.1 and 77.8 % respectively for ASAQ and AL. The cure rate was higher in older patients than in children under 5 years old. The risk of re-infection by day 28 was higher in AL treated patients compared with those receiving ASAQ (p |
| Databáze: | OpenAIRE |
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