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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 December 2015
• Main ID: NCT01958905
• Date of registration: 07/10/2013
• Prospective Registration: Yes
• Primary sponsor: Epicentre
• Public title: Efficacy and Bio-availability of Artemether-Lumefantrine in Severely Malnourished Children MAL-NUT
• Scientific title: Efficacy and Bio-availability of Artemether-Lumefantrine Fixed Combination in Severely Malnourished Children Compared to Non-severely Malnourished Children
• Date of first enrolment: November 2013
• Target sample size: 399
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01958905
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Mali, Niger

Contacts

• Name: Jean-Francois Etard, MD, PHD
• Affiliation: Epicentre

Key inclusion & exclusion 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)



Age minimum: 6 Months
Age maximum: 5 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria

Severe Acute Malnutrition

Intervention(s)

Drug: Artemether-lumefantrine fixed combination

Primary Outcome(s)

Proportion of adequate clinical and parasitological response after PCR correction [Time Frame: 28 days]

Secondary Outcome(s)

Proportion of reinfection and recrudescence [Time Frame: 28 and 42 days]

Bio-availability of lumefantrine [Time Frame: 21 days]

Percentage of adequate clinical and parasitological response corrected by PCR [Time Frame: 42 days]

Proportion of treatment failures by types (Early Treatment Failure, Late Clinical Failure, Late Parasitological Failure) [Time Frame: 28 and 42 days]

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

Secondary ID(s)

824338

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Cape Town

Malaria Research and Training Center, Bamako, Mali