Efficacy of Antimalarial Drugs Used for the Treatment of Uncomplicated Malaria, Plasmodium Falciparum, at the Agadez, Gaya and Tessaoua Sentinel Sites
NCT05070520 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 259
Last updated 2021-10-07
Summary
In Niger, malaria is a major public health problem. It is the main cause of morbidity and mortality among children. The management of malaria cases is based on the principle of early diagnosis and rapid treatment with effective drugs. It is confronted with the appearance of strains resistant to antimalarial drugs, hence the need to monitor antimalarial drug sensitivity.
The study was conducted in three regions representing epidemiological strata of the country: Agadez (Centre de santé Intégré of Dagamanet in the Health district of Agadez), Maradi (Centre de santé intégré of Guindaoua in Tessaoua) and Dosso (Centre de santé Intégré centre in Gaya). The protocol used is the WHO standardized protocol of 2009. Artemether/Lumefantrine (AL) was administered with a 28-day follow-up in children aged 3 months to 15 years. A Polymerase Chain Reaction (PCR) correction is planned to differentiate between treatment failure and re-infestation as well as a study of genes responsible for resistance on the main drugs used.
Conditions
Interventions
- DRUG
-
Artemether-lumefantrine
Efficacy of artemether lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sentinel sites in Niger (Agadez, Gaya and Tessaoua) in 2020
Sponsors & Collaborators
-
Programme National de Lutte contre le Paludisme, Niger
lead OTHER_GOV
Principal Investigators
-
Hadiza JACKOU, Dr · PROGRAMME NATIONAL DE LUTTE CONTRE LE PALUDISME
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Months
- Max Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-01
- Primary Completion
- 2020-09-30
- Completion
- 2020-10-28
Countries
- Niger
Study Locations
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