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

This study has been completed.
Sponsor:
Collaborator:
Centre de Recherche en Sante de Nouna, Burkina Faso
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00261222
First received: November 30, 2005
Last updated: February 2, 2010
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Malaria
Drug: Amodiaquine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.
  • Early clinical failure rate in urban study area.
  • Total late parasitological failure rate on day 14 and 28.
  • Late parasitological failure rate on day 14 and 28 in rural study area.
  • Late parasitological failure rate on day 14 and 28 in urban study area.
  • Incidence of observed and self-reported adverse events over the 28 days observation period
  • Monitoring of concomitant drug intake

Estimated Enrollment: 120
Study Start Date: September 2005
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261222

Locations
Burkina Faso
Centre de Recherche en Santé de Nouna (CRSN)
Nouna, Burkina Faso, P.O. Box 34
Sponsors and Collaborators
Heidelberg University
Centre de Recherche en Sante de Nouna, Burkina Faso
Investigators
Principal Investigator: Germain Mandi, MD Centre de Recherche en Santé de Nouna
Study Director: Olaf Mueller, MD, PhD University of Heidelberg, Germany, Institute of Tropical Medecine and Public Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00261222     History of Changes
Other Study ID Numbers: SFB544-A8-AQ2005
Study First Received: November 30, 2005
Last Updated: February 2, 2010
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by Heidelberg University:
Amodiaquine
Efficacy
Malaria
Burkina Faso

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Amodiaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014