Malaria Clinical Trial
— MAL-NUTOfficial title:
Efficacy and Bio-availability of Artemether-Lumefantrine Fixed Combination in Severely Malnourished Children Compared to Non-severely Malnourished Children
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.
Status | Completed |
Enrollment | 399 |
Est. completion date | May 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 5 Years |
Eligibility |
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) |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mali | District Hospital | Ouelessebougou | |
Niger | CSI Andoumè | Maradi city |
Lead Sponsor | Collaborator |
---|---|
Epicentre | Malaria Research and Training Center, Bamako, Mali, University of Cape Town |
Mali, Niger,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Level of antimalarial antibodies at enrolment | Enrolment | No | |
Primary | Proportion of adequate clinical and parasitological response after PCR correction | Standard primary outcome as defined wy the WHO guidelines for assessing antimalarial efficacy | 28 days | No |
Secondary | Percentage of adequate clinical and parasitological response corrected by PCR | same as primary outcome but after 42 days of follow-up | 42 days | No |
Secondary | Proportion of treatment failures by types (Early Treatment Failure, Late Clinical Failure, Late Parasitological Failure) | Endpoints defined by the standardised WHO protocol | 28 and 42 days | No |
Secondary | Proportion of reinfection and recrudescence | 28 and 42 days | No | |
Secondary | Bio-availability of lumefantrine | Area under curve, Cmax, Tmax of lumefantrine (estimated through population based approach, 5 samples collected per subject) | 21 days | No |
Secondary | Type and frequency of adverse events | 42 days | Yes |
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