Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria. (ALE)

Richard Mwaiswelo

Status and phase: Completed; Phase 4

Conditions: Plasmodium Falciparum Malaria

Treatments: Drug: Artemether-lumefantrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02089841

3.0.2011

Details and patient eligibility

About

Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated malaria since 2007. Nonetheless, a report of increased proportion of patients with parasitaemia on day 1 following treatment with artemisinin based combination therapies has emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria among children after five years of wide scale use of the drug in Tanzania.

Full description

Artemisinin based combination therapies (ACTs) are currently recommended by the World Health Organization (WHO) as first-line treatment for uncomplicated malaria in all malaria endemic countries including Tanzania, that adopted the policy in 2007. ACTs have proven to be highly efficacious in different parts of the world with different malaria endemicity. Artemisinins clear asexual parasites rapidly and they are also potent against P. falciparum gametocytes, hence reducing disease transmission and spread of drug resistance. Nonetheless, a report in Kenya shows an increase in proportion of patients with parasitaemia on day 1. Most recently, resistance against artemisinins has been confirmed in four countries of South-East Asia, and it may spread to Africa.

In order to safeguard ACTs life span, WHO recommends all suspected malaria cases to be confirmed with parasitological diagnosis, followed by prompt treatment with effective antimalarials. It also emphasizes on the need to conduct efficacy studies for the first and second line antimalarial treatments after every two years so as to be able to detect resistance early on its course. Therefore, based on this notion, this study aimed to assess the therapeutic efficacy of Artemether/Lumefantrine among children with uncomplicated falciparum malaria in Bagamoyo district, five years after its wide scale use in Tanzania.

Enrollment: 140 patients

Sex: All

Ages: 6 to 120 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mono-infection with P. falciparum
• Parasitaemia level of 2000 - 200,000/μL
• Absence of danger signs or signs of severe malaria
• Axillary temperature ≥ 37.5°C or history of fever 24 hours prior to coming to the facility
• Absence of other concomitant infections like pneumonia which can cause fever
• No use of antimalarial drug two weeks prior to the study
• Consent to comply to the protocol.

Exclusion criteria

• Presence of general danger signs or signs of severe falciparum malaria
• Severe malnutrition
• Febrile condition due to diseases other than malaria, such as measles, acute lower respiratory infection or other known chronic diseases
• Regular medication which might interfere with antimalarial pharmacokinetics
• History of hypersensitivity reactions or contraindications to any medicine being used in the trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Artemether/lumefantrine

Experimental group

Description:

In this single-arm study, patients will be treated with Artemether/lumefantrine, and the first, third and fifth doses of the drug will be given under the direct observation of the health workers. The patients will be followed-up for 42 days, on day 1, 2, 3, 7, 14, 21, 28 and 42 to assess the efficacy of the drug.

Treatment:

Drug: Artemether-lumefantrine