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

NCT01958905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2015-12-18

No results posted yet for this study

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.

Conditions

  • Malaria
  • Severe Acute Malnutrition

Interventions

DRUG

Artemether-lumefantrine fixed combination

Sponsors & Collaborators

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • Epicentre

    lead OTHER

Principal Investigators

  • Jean-Francois Etard, MD, PHD · Epicentre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-03-31
Completion
2015-05-31

Countries

  • Mali
  • Niger

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01958905 on ClinicalTrials.gov