Efficacy and Bio-availability of Artemether-Lumefantrine in Severely Malnourished Children

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Epicentre
• Collaborators: Malaria Research and Training Center, Bamako, Mali; University of Cape Town
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Lumefantrine

Criteria

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)