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Efficacy of Amodiaquine-artesunate in Children Aged 6-59 Months With Uncomplicated P. Falciparum Malaria (IPTi DRWG)

This study has been completed.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Kenya Medical Research Institute
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00425763
First received: January 19, 2007
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

We will be studying the clinical efficacy of amodiaquine-artesunate currently being studied in an intermittent preventive therapy in infants (IPTi)trial in the same area in order to correlate preventive efficacy seen in IPTi with efficacy for treatment of symptomatic malaria for each regimen.


Condition Intervention Phase
Malaria
 Drug: AQAS
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Amodiaquine-artesunate in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children at an IPTi Site in Rural Western Kenya

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 28 Day Adequate Clinical and Parasitological Response, Early Treatment Failure, Late Clinical Failure, Late Parasitological

Secondary Outcome Measures:
  • Side effects
  • Molecular markers of drug resistance

Enrollment: 110
Study Start Date: May 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AQAS Drug: AQAS
AQAS dosed by body weight, on days 0, 1, 2

Detailed Description:

We propose to conduct an amodiaquine-artesunate efficacy trial at Bondo District Hospital in Kenya. The results will enable us to better interpret the results of the main IPTi trial. We will assess the efficacy of a three day course of amodiaquine plus three days of artesunate (AQ3/AS3) for the treatment of symptomatic, uncomplicated P. falciparum infections. Study subjects are febrile children, 6-59 months old, with laboratory-confirmed uncomplicated P. falciparum infections. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. Children will be followed closely for signs of drug failure or recrudescence, and any children failing therapy will be treated with Coartem or, if severe, with quinine. We will also perform drug resistance testing on parasite samples from children with treatment failure. The results of this efficacy trial will allow us to assist policymakers in deciding what drugs should be used for IPTi, should it be adopted into national policy.

  Eligibility

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

Inclusion Criteria:

  • age 6-59 months
  • axillary temperature ≥ 37.5º C, or history of fever in previous 24 hours
  • weight ≥ 5.0 kg
  • slide-confirmed infection with P. falciparum
  • parasitemia 2000-200,000 asexual forms per μl
  • ability and willingness to attend stipulated follow-up visits

Exclusion Criteria:

  • signs or symptoms of severe disease
  • weight-for-age ≤ 3rd percentile on Kenya growth charts
  • slide confirmed infection with any other Plasmodium spp., besides falciparum
  • severe anemia, defined as Hb < 7 g/dl
  • known hypersensitivity to any of the drugs being tested
  • enrolled in IPTi trial
  • known chronic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425763

Locations
Kenya
Bondo District Hospital
Kisumu, Kenya
Sponsors and Collaborators
Centers for Disease Control and Prevention
London School of Hygiene and Tropical Medicine
Kenya Medical Research Institute
Investigators
Principal Investigator: Meghna Desai, PhD Centers for Disease Control and Prevention
Principal Investigator: Mary Hamel, MD Centers for Disease Control and Prevention
Study Chair: Patrick Kachur, MD, MPH Centers for Disease Control and Prevention
Study Chair: Robert Newman, MD, MPH Centers for Disease Control and Prevention
Study Chair: Larry Slutsker, MD, MPH Centers for Disease Control and Prevention
Study Director: Julie Thwing, MD Centers for Disease Control and Prevention
Study Director: Christopher O Odero CDC/KEMRI
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00425763     History of Changes
Other Study ID Numbers: CDC-NCID-5022, KEMRI-SSC-1190
Study First Received: January 19, 2007
Last Updated: April 4, 2012
Health Authority: United States: Federal Government
Kenya: Institutional Review Board

Keywords provided by Centers for Disease Control and Prevention:
malaria
efficacy
intermittent preventive therapy in infants
drug resistance

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

ClinicalTrials.gov processed this record on May 23, 2013