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

This study has been withdrawn prior to enrollment.
(The ethics committee did not approve the pharmacokinetic part of the study.)
Sponsor:
Collaborator:
Doctors Without Borders (Médecins Sans Frontières OCBA, Barcelona, Spain)
Information provided by (Responsible Party):
Epicentre
ClinicalTrials.gov Identifier:
NCT01204411
First received: September 16, 2010
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Malaria, Falciparum
Malnutrition
Child
Drug: Artesunate-amodiaquine fixed-dose combination
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Epicentre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the incidence of adverse events during the follow-up period [ Time Frame: 42 day follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 0
Intervention Details:
    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;
    Other Name: AS-AQ Winthrop® Sanofi Aventis
  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204411

Locations
Niger
Integrated health centre (CSI)
Madaoua, Tahoua, Niger
Sponsors and Collaborators
Epicentre
Doctors Without Borders (Médecins Sans Frontières OCBA, Barcelona, Spain)
Investigators
Principal Investigator: Francesco Grandesso, MSc Epicentre
  More Information

No publications provided

Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT01204411     History of Changes
Other Study ID Numbers: Epicentre/Nig/2010/PaluMadaua
Study First Received: September 16, 2010
Last Updated: November 29, 2012
Health Authority: Niger: Institutional Review Board

Keywords provided by Epicentre:
Efficacy
Safety
Artesunate-amodiaquine
Malaria
Plasmodium falciparum
Malnutrition

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Malnutrition
Nutrition Disorders
Parasitic Diseases
Protozoan Infections
Amodiaquine
Amodiaquine, artesunate drug combination
Artesunate
Amebicides
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014