NCT01204411

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

First QC Date

September 16, 2010

Last Update Submit

November 29, 2012

Conditions

Malaria, FalciparumMalnutritionChild

Keywords

EfficacySafetyArtesunate-amodiaquineMalariaPlasmodium falciparumMalnutrition

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    42 day follow-up

Interventions

Artesunate-amodiaquine fixed-dose combinationDRUG

* 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;

Also known as: AS-AQ Winthrop® Sanofi Aventis

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrated health centre (CSI)

Madaoua, Tahoua Region, Niger

Location

MeSH Terms

Conditions

Malaria, FalciparumMalnutritionMalaria

Interventions

amodiaquine, artesunate drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Francesco Grandesso, MSc

    Epicentre

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2010

First Posted

September 17, 2010

Last Updated

November 30, 2012

Record last verified: 2012-11

Locations

NI(1)