A Phase 4 interventional study of Artemether-lumefantrine in MALARIA, sponsored by Programme National de Lutte contre le Paludisme, Niger. Completed at 1 site in Niger. Open to participants aged 3 Months to 15 Years. Per ClinicalTrials.gov, last updated 2021-10-07.
Sponsored by Programme National de Lutte contre le Paludisme, Niger · Phase 4, Interventional, and Treatment
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.
The study took place from September 1 to October 31, 2020 at the time of peak malaria transmission. It took place at three sentinel sites of the National Malaria Control Program (NMCP). These were in the regions of i) Agadez at the Centre de Santé Intégré (CSI) of Dagamanet in the Agadez district, ii) Dosso at the CSI centre in the health district (HD) of Gaya iii) Maradi at the CSI Guindaoua in the HD of Tessaoua. These sites were identified by the NMCP because of their high attendance rate and belong to 3 different malaria epidemiological strata.
As the treatment failure rate of artemether lumefantrine (AL) in the regions is unknown, 5% was chosen. With a confidence level of 95% and a precision around the estimate of 5%, a minimum of 73 patients were included. The number of patients was increased by 20% to account for possible dropouts and withdrawals during the 28/42 day follow-up period, 88 patients were included in the study per site.
The study drug is oral AL. It is one of the four antimalarial drugs selected by the Niger's NMCP for the management of malaria. The product consists of blister packs of 6 tablets, box of 30 of lot number K U142 with an expiration date of January 2022 and blister packs of 12 tablets, box of 30 of lot number K U456 with an expiration date of January 2022.
The AL combination was administered at a dose of 4 mg artemether and 24 mg lumefantrine per kg for three days. The AL was provided by the NMCP.
The different prescriptions were as follows:
The first day's intake was done under direct observation and possible side effects were noted. Any patient who persistently vomited after taking the medication was excluded from the study and treated with artesunate. Patients were followed up regularly until Day 28 and received a clinical examination with thick drop control and axillary temperature taking at Day 0, Day 1, Day 2, Day 3, Day 7, Day 14, Day 21, and Day 28. Capillary blood on filtered paper (Wattman) was routinely collected from all patients on the day of inclusion ( Day 0) and during follow-up for molecular analysis. For follow-up, the density of asexual parasite forms was assessed on the basis of 8 000 leukocytes per microliter of blood. All slides were read by two microscopists to ensure control. At the end of the follow-up, the response to treatment was classified according to clinical and parasitological criteria
Exclusion Criteria:
Efficacy of artemether lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sentinel sites in Niger (Agadez, Gaya and Tessaoua) in 2020
Percentage of patients with asexual falciparum parasitaemia on Day 0.
Parasitaemia always refers to falciparum species. Mixed infections detected by light microscopy was excluded.
Time frame: 4 weeks
Number of patiants with presence of gametocytes on Day 0
Time frame: 4 weeks
Percentage of patients with danger signs of malaria on Day 1
Depending on the classification, a patient will be considered as having experienced treatment failure if the danger signs are associated with the presence of parasites.
Time frame: 4 weeks
Proportion of patients with 'adequate clinical and parasitological response' (ACPR) before PCR-corrected
absence of parasitaemia on day 28 (day 42), irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure
Time frame: 8 weeks
Proportion of patients with 'adequate clinical and parasitological response' (ACPR) after PCR-corrected
PCR analysis
Time frame: 24 weeks
Proportion of patients with 'early treatment failure' (ETF) before PCR-corrected
* Danger signs or severe malaria on day 1, 2 or 3, in the presence of parasitaemia; * Parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature; * Parasitaemia on day 3 with axillary temperature ≥ 37.5 °C; and * Parasitaemia on day 3 ≥ 25% of count on day 0
Time frame: 8 weeks
Proportion of patients with 'early treatment failure' (ETF) after PCR-corrected
-PCR analysis
Time frame: 24 weeks
Proportion of patients with 'late clinical failure' (LCF) before PCR-corrected
* danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 (day 42) in patients who did not previously meet any of the criteria of early treatment failure; and * presence of parasitaemia on any day between day 4 and day 28 (day 42) with axillary temperature ≥ 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure
Time frame: 8 weeks
Proportion of patients with 'late clinical failure' (LCF) after PCR-corrected
PCR analysis
Time frame: 24 weeks
Proportion of patients with 'late parasitological failure' (LPF) before PCR-corrected
presence of parasitaemia on any day between day 7 and day 28 (day 42) with axillary temperature \< 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure.
Time frame: 8 weeks
Proportion of patients with 'late parasitological failure' (LPF) after PCR-corrected
PCR analysis
Time frame: 24 weeks
Percentage of the known mutations associated with artemisinin resistance observed.
PCR analysis
Time frame: 24 weeks
Plan to share: Undecided — Data could be used for thesis
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