Efficacy of Artesunate-amodiaquine (AS-AQ) in Children With Malaria and Severe Acute Malnutrition, Madaoua, Niger 2010

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WITHDRAWN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

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