Study of the artemether-lumefantrine combination for the treatment of uncomplicated Malaria in Bengo Province, Angola

Phase 4

Completed

• Conditions: Treatment of non-complicated malaria in children aged 2 to 10 years old; Infections and Infestations

• Registration Number: ISRCTN78910521
• Lead Sponsor: Hospital Pediátrico David Bernardino - Dr. Luís Bernardino

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-13
• Study Start: 2023-04-26
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Children =2, =10-year-old, both sexes.
2. Body weight. We assume the upper 50% quartile (WHO child growth reference, WHO http:// www.who.int/childgrowth/standards/weight_for_age/en/) for inclusion, i.e. =9 Kg, with no evidence of severe sub-nutrition.
3. Plasmodium falciparum non-complicated malaria defined by axillar temperature =37.5°C (oral/rectal/tympanum =38°C) + microscopically confirmed Plasmodium falciparum parasitemia >1,000 =200,000 parasites/µL.
4. Written informed consent by the Patient’s Guardian.
5. Capacity to swallow medication.
6. Absence of antimalarial exposure during the last two weeks.
7. Having residence inside the CISA Demographic Survey Project

Exclusion Criteria

1. Symptoms of severe malaria, requesting specific parental treatment, in accordance with WHO guidelines.
2. Oral treatment intolerance, including gastro-intestinal events (e.g. repeated vomiting or severe diarrhea) incompatible with an adequate drug absorption.
3. Clinical History or recent events of potentially confounding acute or chronicle conditions.
4. Anaemia at arrival (Hb <7g/dL)
5. Fever caused by conditions other than malaria.
6. Documented hyper-sensitivity to lumefantrine and artemisinin compounds.
7. Treatment with antimalarial in the last two weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified