Clinical trial NCT00425763: Efficacy of Amodiaquine-artesunate in Children Aged 6-59 Months With Uncomplicated P. Falciparum Malaria
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: malaria
efficacy
intermittent preventive therapy in infants
drug resistance
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: London School of Hygiene and Tropical Medicine
name: Kenya Medical Research Institute
First posted: 2007-01-23
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 28 Day Adequate Clinical and Parasitological Response, Early Treatment Failure, Late Clinical Failure, Late Parasitological
Secondary outcomes:
measure: Side effects
measure: Molecular markers of drug resistance
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Bondo District Hospital
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Meghna Desai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Mary Hamel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Patrick Kachur, MD, MPH
role: STUDY_CHAIR
affiliation: Centers for Disease Control and Prevention
name: Robert Newman, MD, MPH
role: STUDY_CHAIR
affiliation: Centers for Disease Control and Prevention
name: Larry Slutsker, MD, MPH
role: STUDY_CHAIR
affiliation: Centers for Disease Control and Prevention
name: Julie Thwing, MD
role: STUDY_DIRECTOR
affiliation: CDC/KEMRI
name: Christopher O Odero
role: STUDY_DIRECTOR
References: