Impact of Insecticide-Treated Curtains on Antimalarial Drug Resistance

This study has been completed.
Sponsor:
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00169078
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Attempts to understand the relationship malaria transmission intensity and antimalarial drug resistance had rested mainly on mathematical models. To date, except for two studies which reported reductions in the prevalence of drug resistance in Tanzania and Zimbabwe, no other field data addressed the impact of reducing malaria transmission by the use of vector control measures on antimalarial drug resistance. Thus whether vector control decrease or increase drug resistance remains a contentious issue. The aim of this study was to investigate the impact of insecticide-treated curtains (ITCs) on clinical and parasitological outcomes in children with uncomplicated malaria treated with chloroquine (CQ), on the prevalence of genetic markers of resistance to CQ and sulphadoxine-pyrimethamine (SP) and on the ability of children to clear drug resistant parasites. The therapeutic efficacy of CQ was studied in 9 villages which used ITCs for 6-8 years and 9 villages with no history of ITC use. A cross-sectional survey was also conducted to estimate the prevalence of genetic markers of resistance to CQ and SP in asymptomatic children.


Condition Intervention
Malaria
Drug: Chloroquine

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: A Study of the Impact of Insecticide-Treated Curtains on the Prevalence of Antimalarial Drug Resistance in Children With Uncomplicated Malaria in Burkina Faso

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Clinical and parasitological failure rates by day 14
  • Prevalence of pfcrt-76T, pfmdr1-86Y before treatment

Secondary Outcome Measures:
  • Proportion of children who cleared parasites carrying pfcrt-76T and pfmdr1-86Y alleles.
  • Prevalence of dhfr-51, 59, 108 and dhps-437, 540

Estimated Enrollment: 1035
Study Start Date: July 2002
Estimated Study Completion Date: December 2002
  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

Age between 6 and 59 months Mono infection with P.falciparum malaria, with parasitaemia in the range of 1,000 to 150,000 parasites per ml Absence of danger signs or signs of severe malaria. Axillary temperature >= 37.5 ºC. Absence of signs of severe malnutrition. Absence of any obvious cause of fever other than malaria. No history of allergy to CQ. Willingness to return to the health facility for follow-up. Informed consent obtained from the caretaker of the child

Exclusion Criteria:

Danger signs of severe or complicated malaria, persisted vomiting. Received treatment with an antimalarial drug other than CQ in the last 2 weeks. Caretaker did not sign the consent form

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00169078

Locations
Burkina Faso
Centre National de Recherche et de Formation sur le Paludisme
Ouagadougou, Kadiogo, Burkina Faso, 2208
Sponsors and Collaborators
Gates Malaria Partnership
Investigators
Principal Investigator: Simon Cousens, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Brian M Greenwood, FRCP FRS London School of Hygiene and Tropical Medicine
Principal Investigator: Diadier Diallo, MsC Centre National de Recherche et de Formation sur le Paludisme
Principal Investigator: Colin Sutherland, PhD London School of Hygiene and Tropical Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00169078     History of Changes
Other Study ID Numbers: ITCR5093
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Gates Malaria Partnership:
Transmission intensity
Insecticide-treated materials
antimalarial drug resistance

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

ClinicalTrials.gov processed this record on September 30, 2014