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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01204411
• Other study ID #: Epicentre/Nig/2010/PaluMadaua
• Status: Withdrawn
• Phase: Phase 4
• First received: September 16, 2010
• Last updated: November 29, 2012

Study information

• Verified date: November 2012
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Niger: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Child
• Malaria
• Malaria, Falciparum
• Malnutrition

Intervention

Drug:
• Artesunate-amodiaquine fixed-dose combination
artesunate 25 mg / amodiaquine 67.5 mg: 1 tablet / day for 3 days for children with a weight of 5 kg to less than 9 kg; artesunate 50 mg / amodiaquine 135 mg: 1 tablet / day for 3 days for children with a weight of 9 kg to less than 18 kg; artesunate 100 mg / amodiaquine 270 mg: 1 tablet / day for 3 days for children with a weight of 18 kg to less than 36 kg;

Locations

Country	Name	City	State
Niger	Integrated health centre (CSI)	Madaoua	Tahoua

Sponsors (2)

Lead Sponsor	Collaborator
Epicentre	Doctors Without Borders (Médecins Sans Frontières OCBA, Barcelona, Spain)

Country where clinical trial is conducted

Niger, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		42 day follow-up	No
Secondary	To assess the incidence of adverse events during the follow-up period		42 day follow-up	Yes