- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01204411
Efficacy of Artesunate-amodiaquine (AS-AQ) in Children With Malaria and Severe Acute Malnutrition, Madaoua, Niger 2010
Efficacy of the Artesunate-amodiaquine Combination for Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Between 6 and 59 Months of Age With Severe Acute Malnutrition in Madaoua, Tahoua Region, Niger
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.
Infection with Plasmodium falciparum malaria remains a significant cause of morbidity and mortality in malnourished children. Malnutrition is known to have a modulating effect on the incidence of malaria infections, its severity and effectiveness of treatments. However, little data exists on antimalarial drug efficacy in malnourished children. Artesunate-amodiaquine combination is the first line treatment used in Médecins Sans Frontières programmes in Niger. The assumption of current efficacy of artesunate-amodiaquine is based on non malnourished children. The aim of this study is to measure the clinical and parasitological efficacy in severely malnourished children.
The study is consistent with the standard WHO protocol for monitoring antimalarial drug efficacy (WHO: Methods for surveillance of antimalarial drug efficacy. Geneva; 2009), except for one inclusion criterion. Severe acute malnutrition is an inclusion criteria, instead of being an exclusion criteria. The study will encompass a pharmacokinetic part that will provide important information on the absorption of the drug.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Tahoua
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Madaoua, Tahoua, Niger
- Integrated health centre (CSI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To measure the PCR adjusted clinical and parasitological efficacy of the artesunate-amodiaquine combination in children 6-59 months of age with severe malnutrition and uncomplicated P. falciparum malaria over a period of 42 days.
Time Frame: 42 day follow-up
|
42 day follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the incidence of adverse events during the follow-up period
Time Frame: 42 day follow-up
|
42 day follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Nutrition Disorders
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Malnutrition
- Malaria, Falciparum
- Severe Acute Malnutrition
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Anthelmintics
- Schistosomicides
- Antiplatyhelmintic Agents
- Artesunate
- Amodiaquine
Other Study ID Numbers
- Epicentre/Nig/2010/PaluMadaua
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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