Status:
WITHDRAWN
Efficacy of Artesunate-amodiaquine (AS-AQ) in Children With Malaria and Severe Acute Malnutrition, Madaoua, Niger 2010
Lead Sponsor:
Epicentre
Collaborating Sponsors:
Medecins Sans Frontieres, Spain
Conditions:
Malaria, Falciparum
Malnutrition
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine whether the artesunate-amodiaquine combination is effective in treating uncomplicated Plasmodium falciparum malaria in children with severe acute malnutrition....
Eligibility Criteria
Inclusion
- Age between 6 and 59 months
- Weight ≥5kg
- P. falciparum monoinfection confirmed on a thick blood film
- Parasitic density between 1,000 and 200,000 asexual forms/uL of blood
- Measured axillary temperature ≥37.5°C or history of fever during the previous 24 hours
- Severe malnutrition (defined as a weight/height ratio less than -3 z-scores)
- High probability of compliance with follow-up visits (home is within two hours of walk from the outpatient department, no near-term travel plans, etc..)
- Consent of a parent or guardian who is at least 18 years of age.
Exclusion
- Signs of a critical illness as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11).
- Signs of severe or complicated malaria as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11).
- Severe anaemia (haemoglobin \<5 g/dL)
- Known history of hypersensitivity to any of the study medications,
- Symmetric oedema in the feet,
- Concomitant febrile illness not originating from malaria, which could alter the outcome of the study (measles, acute lower respiratory tract infection, otitis media, tonsillitis, abscesses, severe diarrhea with dehydration, etc.),
- History of a full treatment course with the study drug in the past 28 days.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01204411
Last Update
November 30 2012
Active Locations (1)
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1
Integrated health centre (CSI)
Madaoua, Tahoua Region, Niger