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

April 4, 2012 updated by: Centers for Disease Control and Prevention

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • Bondo District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AQAS
Drug: AQAS
AQAS dosed by body weight, on days 0, 1, 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
28 Day Adequate Clinical and Parasitological Response, Early Treatment Failure, Late Clinical Failure, Late Parasitological

Secondary Outcome Measures

Outcome Measure
Side effects
Molecular markers of drug resistance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

January 19, 2007

First Submitted That Met QC Criteria

January 19, 2007

First Posted (Estimate)

January 23, 2007

Study Record Updates

Last Update Posted (Estimate)

April 5, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCID-5022
  • KEMRI-SSC-1190

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe