Clinical trial NCT02089841: Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria.
Official title: Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Five Years After Wide Scale Use of the Drug in Tanzania.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plasmodium Falciparum Malaria
Keywords: Efficacy
Artemether/lumefantrine
Malaria
Children
Lead sponsor: Muhimbili University of Health and Allied Sciences
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2014-03-18
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients without parasitaemia on day 42.
timeFrame: 42 Days
Secondary outcomes:
measure: Plasma lumefantrine concentration
timeFrame: 7 days and 14 days
Other outcomes:
measure: Proportional of patients without parasitaemia on day 42
timeFrame: 42 days
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences
Study officials:
affiliation: Karolinska Institutet
name: Andreas Martensson, PhD
role: STUDY_DIRECTOR
References: