Efficacy of Antimalarial Drugs Used for the Treatment of Uncomplicated Malaria, Plasmodium Falciparum, at the Agadez, Gaya and Tessaoua Sentinel Sites

• Status: Completed
• Trial end date: 2020-10-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Programme National de Lutte contre le Paludisme, Niger
• Treatments: Artemether; Artemether, Lumefantrine Drug Combination; Lumefantrine

Criteria

Inclusion Criteria:

• Brachial circumference (BC) > 125 mm and P/T z-score > -2 Standard Deviation (SD)

• Age between three months and fifteen years,

• Monospecific Plasmodium falciparum infestation detected by microscopy;

• Parasitemia between 1000 and 200000 asexual parasitic forms/µl ;

• Axillary temperature ≥37.5° or history of fever in the past 24 hours ;

• Ability to take oral medications;

• Ability and willingness to adhere to the protocol for the duration of the study and to adhere to the visit schedule ;

• Informed consent of the accompanying person (guardian or parent).

Exclusion Criteria:

• Inability to take oral medications

• History of antimalarial treatment in the past two weeks, including sulfadoxine-pyrimethamine (SPAQ) for seasonal malaria chemoprevention (SMC)

• Lack of consent for pregnancy testing

• Presence of general danger signs in children under five years of age or signs of severe P. falciparum malaria as defined by World Health Organization (WHO);

• Mixed infestation or monospecific infestation with another Plasmodium species, detected by microscopic examination;

• Severe malnutrition defined by a BC <125 mm AND P/T z-score < -3 Standard Deviation (SD)

• Moderate malnutrition defined by a BC <125 mm AND a -3 ≤P/T z-score < -2 SD

• Febrile condition due to illnesses other than malaria (e.g., measles, acute lower respiratory tract infection, severe diarrheal illness with dehydration) or other known chronic or severe underlying illnesses (e.g., cardiac, renal, or liver disease, HIV/AIDS) ;

• Regular use of medications that may interfere with antimalarial pharmacokinetics;

• History of hypersensitivity or contraindication to any of the drugs tested or used as replacement therapy;

• Lack of informed consent from the patient or accompanying person