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

NCT00425763 | Completed Phase 4

• 2 other identifiers: CDC-NCID-5022KEMRI-SSC-1190
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• Side effects

• Molecular markers of drug resistance

Study Arms (1)

AQAS

EXPERIMENTAL

Drug: AQAS

Interventions

AQAS DRUG

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

AQAS

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Bondo District Hospital

Kisumu, Kenya

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Meghna Desai, PhD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Mary Hamel, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Julie Thwing, MD

  Centers for Disease Control and Prevention

  STUDY DIRECTOR

• Christopher O Odero

  CDC/KEMRI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 23, 2007
• Study Start: May 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: April 5, 2012

Record last verified: 2012-04

Locations

KE (1)