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

Malaria Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425763
• Other study ID #: CDC-NCID-5022
• Secondary ID: KEMRI-SSC-1190
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2007
• Last updated: April 4, 2012
• Start date: May 2007
• Est. completion date: August 2007

Study information

• Verified date: April 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentKenya: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• AQAS
AQAS dosed by body weight, on days 0, 1, 2

Locations

Country	Name	City	State
Kenya	Bondo District Hospital	Kisumu

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Kenya Medical Research Institute, London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 Day Adequate Clinical and Parasitological Response, Early Treatment Failure, Late Clinical Failure, Late Parasitological
Secondary	Side effects
Secondary	Molecular markers of drug resistance