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

Plain-language summary

This study examined the efficacy of malaria treatment with Artemether-lumefantrine in children with uncomplicated Plasmodium falciparum malaria. It enrolled children aged three months to fifteen years with microscopy-confirmed P. falciparum infection who were able to take oral medication. It was a Phase 4 study and is completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Programme National de Lutte contre le Paludisme, Niger

Intervention

Artemether-lumefantrine

Start date

9/1/2020

Estimated completion

10/28/2020

Countries

Niger

Related genes

Locations

• Niamey, Niger

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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