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

Primary Purpose

Malaria, Falciparum, Malnutrition, Child

Status
Withdrawn
Phase
Phase 4
Locations
Niger
Study Type
Interventional
Intervention
Artesunate-amodiaquine fixed-dose combination
Sponsored by
Epicentre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria, Falciparum focused on measuring Efficacy, Safety, Artesunate-amodiaquine, Malaria, Plasmodium falciparum, Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Integrated health centre (CSI)

Outcomes

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.

Secondary Outcome Measures

To assess the incidence of adverse events during the follow-up period

Full Information

First Posted
September 16, 2010
Last Updated
November 29, 2012
Sponsor
Epicentre
Collaborators
Medecins Sans Frontieres, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT01204411
Brief Title
Efficacy of Artesunate-amodiaquine (AS-AQ) in Children With Malaria and Severe Acute Malnutrition, Madaoua, Niger 2010
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Why Stopped
The ethics committee did not approve the pharmacokinetic part of the study.
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epicentre
Collaborators
Medecins Sans Frontieres, Spain

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum, Malnutrition, Child
Keywords
Efficacy, Safety, Artesunate-amodiaquine, Malaria, Plasmodium falciparum, Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Artesunate-amodiaquine fixed-dose combination
Other Intervention Name(s)
AS-AQ Winthrop® Sanofi Aventis
Intervention Description
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;
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To assess the incidence of adverse events during the follow-up period
Time Frame
42 day follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Grandesso, MSc
Organizational Affiliation
Epicentre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated health centre (CSI)
City
Madaoua
State/Province
Tahoua
Country
Niger

12. IPD Sharing Statement

Learn more about this trial

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

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