Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso

NCT00261222 | Completed Phase 2

• 1 other identifier: SFB544-A8-AQ2005
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Design: Single-centre Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN). Population: Children aged 6-59 months with uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C + ≥ 2.000 P. falciparum asexual parasites per µl blood) from the health centre situated in the villages of Bagala, Bourasso and Kemena and from Nouna town hospital outpatient department. Sample size: N=120 Treatment: All children will receive a total dose of 25 mg/kg oral AQ over a period of three days (first and second day: 10mg/kg, third day: 5mg/kg). Statistical procedures: The primary analysis parameter is the proportion of clinical failures on day 14. Secondary parameters are the rate of clinical failures on day 28 (with and without PCR correction), the rate of early clinical failures, the rate of late parasitological failures (day 14 and day 28), and the rate of adverse events. Data will be analysed in the overall group of study children and for rural (n=50) and urban (n=50) study children separately. Study duration and dates: The study will be implemented in September-December 2005.

Conditions

Malaria

Keywords

Amodiaquine; Efficacy; Malaria; Burkina Faso

Outcome Measures

Primary Outcomes (3)

• Total clinical failure rate on day 14.

• Clinical failure rate on day 14 in rural study area.

• Clinical failure rate on day 14 in urban study area.

Secondary Outcomes (11)

• Total clinical failure rate on day 28.

• Clinical failure rate on day 28 in rural study area.

• Clinical failure rate on day 28 in urban study area.

• Total early clinical failure rate.

• Early clinical failure rate in rural study area.

Interventions

Amodiaquine DRUG

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
• Uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C and ≥ 2.000 P. falciparum asexual parasites per µl blood)
• Written informed consent given by the parents/caretakers

You may not qualify if:

• Complicated or severe malaria (repeated vomiting, seizures or other neurological impairment, haemoglobin \< 7 g/dl or haematocrit \< 21%)
• Any apparent significant disease (e. g. pneumonia, meningitis, hepatitis, severe diarrhoea, measles, severe malnutrition)
• Malaria treatment with western drugs and/or antibiotics with anti malarial potency during last 7 days except chloroquine.

Sponsors & Collaborators

• Heidelberg University: lead
• Centre de Recherche en Sante de Nouna, Burkina Faso: collaborator

Study Sites (1)

Centre de Recherche en Santé de Nouna (CRSN)

Nouna, P.O. Box 34, Burkina Faso

Location

MeSH Terms

Conditions

Malaria

Interventions

Amodiaquine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Germain Mandi, MD

  Centre de Recherche en Santé de Nouna

  PRINCIPAL INVESTIGATOR

• Olaf Mueller, MD, PhD

  University of Heidelberg, Germany, Institute of Tropical Medecine and Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2005
• First Posted: December 2, 2005
• Study Start: September 1, 2005
• Study Completion: November 1, 2005
• Last Updated: February 3, 2010

Record last verified: 2006-10

Locations

BU (1)