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

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ClinicalTrials.gov Identifier: NCT02089841
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Richard Mwaiswelo, Muhimbili University of Health and Allied Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Plasmodium Falciparum Malaria Drug: Artemether-lumefantrine Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arms and Interventions
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Arm Intervention/treatment
Experimental: Artemether/lumefantrine
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.
 Drug: Artemether-lumefantrine
Blood samples will be collected on blood slides and filter papers for asexual parasites assessment both by microscope and molecular genotyping respectively following treatment with artemether-lumefantrine, to assess its efficacy.
Other Name: Coartem


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients without parasitaemia on day 42. [ Time Frame: 42 Days ]
    Proportion of patients without parasitaemia or with new infection as corrected by molecular genotyping on day 42 will be used to calculate the efficacy of the trial medicine.


Secondary Outcome Measures :
  1. Plasma lumefantrine concentration [ Time Frame: 7 days and 14 days ]
    Mean plasma lumefantrine concentration among patients on day 7 and day 14 following treatment with artemether/lumefantrine as a predictor of cure rate.


Other Outcome Measures:
  1. Proportional of patients without parasitaemia on day 42 [ Time Frame: 42 days ]
    Proportion of patients without parasitaemia on day 42 as purely assessed by molecular genotyping of all collected samples on this day, differentiate between recrudescence and new infection and use it to calculate the efficacy of the trial medicine.


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 120 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089841


Locations
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Tanzania
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania, P.O Box 65001
Sponsors and Collaborators
Richard Mwaiswelo
Karolinska Institutet
Investigators
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Study Director: Andreas Martensson, PhD Karolinska Institutet
More Information
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Responsible Party: Richard Mwaiswelo, Investigator, Muhimbili University of Health and Allied Sciences
ClinicalTrials.gov Identifier: NCT02089841    
Other Study ID Numbers: 3.0.2011
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014
Keywords provided by Richard Mwaiswelo, Muhimbili University of Health and Allied Sciences:
Efficacy
Artemether/lumefantrine
Malaria
Children
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
 Artemether, Lumefantrine Drug Combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents