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Efficacy and Bio-availability of Artemether-Lumefantrine in Severely Malnourished Children (MAL-NUT)

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ClinicalTrials.gov Identifier: NCT01958905
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : December 18, 2015
Malaria Research and Training Center, Bamako, Mali
University of Cape Town
Information provided by (Responsible Party):

Brief Summary:
The general objective of the study is to answer to the question: "Is the current dose of AL less efficacious in the severely malnourished compared to the non-severely malnourished children, and is PK in cause?" We aim to assess whether the current treatment dose is adequate for children with severe acute malnutrition, and we hope results will guide further recommendations for malaria treatment in this specific population.

Condition or disease Intervention/treatment Phase
Malaria Severe Acute Malnutrition Drug: Artemether-lumefantrine fixed combination Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 399 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Bio-availability of Artemether-Lumefantrine Fixed Combination in Severely Malnourished Children Compared to Non-severely Malnourished Children
Study Start Date : November 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Artemether-Lumefantrine
All patients will receive Artemether-Lumefantrine and the endpoints will be compared between the two populations of severely malnourished and non-severely malnourished children
Drug: Artemether-lumefantrine fixed combination
Other Name: Coartem Novartis

Primary Outcome Measures :
  1. Proportion of adequate clinical and parasitological response after PCR correction [ Time Frame: 28 days ]
    Standard primary outcome as defined wy the WHO guidelines for assessing antimalarial efficacy

Secondary Outcome Measures :
  1. Percentage of adequate clinical and parasitological response corrected by PCR [ Time Frame: 42 days ]
    same as primary outcome but after 42 days of follow-up

  2. Proportion of treatment failures by types (Early Treatment Failure, Late Clinical Failure, Late Parasitological Failure) [ Time Frame: 28 and 42 days ]
    Endpoints defined by the standardised WHO protocol

  3. Proportion of reinfection and recrudescence [ Time Frame: 28 and 42 days ]
  4. Bio-availability of lumefantrine [ Time Frame: 21 days ]
    Area under curve, Cmax, Tmax of lumefantrine (estimated through population based approach, 5 samples collected per subject)

  5. Type and frequency of adverse events [ Time Frame: 42 days ]

Other Outcome Measures:
  1. Level of antimalarial antibodies at enrolment [ Time Frame: Enrolment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 6 and 59 months
  • Weight ≥ 5 kg
  • P. falciparum monoinfection confirmed on a thick blood film
  • Parasitic density between 1,000 and 200,000 asexual forms/µL of blood.
  • Measured axillary temperature ≥ 37.5 ° C or history of fever during the previous 24 hours
  • High probability of compliance with follow-up visits (no near-term travel plans)
  • Consent of a parent or guardian who is at least 18 years of age.
  • According to the group: in severely malnourished, weight-for-height z-score <-3 SD or MUAC <115 mm, and in non-severely malnourished, weight-for-height z-score ≥- 3 standard deviations (SD), and MUAC≥ 115 mm.

Exclusion Criteria:

  • General danger signs or signs of complicated malaria as defined by the WHO (Appendix 1)
  • Mixed or mono-infection with another Plasmodium species detected by microscopy
  • Severe anemia (hemoglobin <5 g / dL)
  • Known underlying chronic or severe disease (e.g. cardiac, renal or hepatic disease, tuberculosis, sickle cell)
  • Known HIV/AIDS infection
  • Known history of hypersensitivity or contra-indication to any of the study medications: artemether, lumefantrine (first-line medications), or artesunate, amodiaquine (rescue medications)
  • Presence of febrile conditions due to diseases other than malaria which could alter the outcome of the study
  • History of a full treatment course with AL in the past 14 days.
  • Height-for-age <-3 Z scores
  • Severe complications of malnutrition requiring hospitalization in intensive care or stabilization: Severe signs of kwashiorkor, Anorexia (failure to the appetite test), Hyperemesis, Severe acute infection, Hypothermia <35 ˚ C (axillary) or hypoglycemia, Diarrhea with dehydration, Lethargy, coma, Clinical signs of vitamin A deficiency (xerophthalmia)

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): NCT01958905

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District Hospital
Ouelessebougou, Mali
CSI Andoumè
Maradi city, Niger
Sponsors and Collaborators
Malaria Research and Training Center, Bamako, Mali
University of Cape Town
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Study Director: Jean-Francois Etard, MD, PHD Epicentre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT01958905    
Other Study ID Numbers: 824338
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Severe Acute Malnutrition
Nutrition Disorders
Artemether, Lumefantrine Drug Combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents