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

Primary Purpose

Malaria

Status

Completed

Phase

Phase 4

Locations

Kenya

Study Type

Interventional

Intervention

AQAS

About this trial

This is an interventional prevention trial for Malaria focused on measuring malaria, efficacy, intermittent preventive therapy in infants, drug resistance

Eligibility Criteria

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

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

Sites / Locations

Bondo District Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AQAS

Arm Description

Outcomes

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

Full Information

NCT ID

NCT00425763

First Posted

January 19, 2007

Last Updated

April 4, 2012

Sponsor

Centers for Disease Control and Prevention

Collaborators

London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00425763

Brief Title

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

Acronym

IPTi DRWG

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Centers for Disease Control and Prevention

Collaborators

London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

malaria, efficacy, intermittent preventive therapy in infants, drug resistance

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AQAS

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AQAS

Intervention Description

AQAS dosed by body weight, on days 0, 1, 2

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Side effects

Title

Molecular markers of drug resistance

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

59 Months

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meghna Desai, PhD

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mary Hamel, MD

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Patrick Kachur, MD, MPH

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Robert Newman, MD, MPH

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Larry Slutsker, MD, MPH

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Julie Thwing, MD

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Christopher O Odero

Organizational Affiliation

CDC/KEMRI

Official's Role

Study Director

Facility Information:

Facility Name

Bondo District Hospital

City

Kisumu

Country

Kenya

12. IPD Sharing Statement

Learn more about this trial

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

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