NCT00169078

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,035

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2002

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

First QC Date

September 9, 2005

Last Update Submit

January 11, 2017

Conditions

Malaria

Keywords

Transmission intensityInsecticide-treated materialsantimalarial drug resistance

Outcome Measures

Primary Outcomes (2)

  • Clinical and parasitological failure rates by day 14

  • Prevalence of pfcrt-76T, pfmdr1-86Y before treatment

Secondary Outcomes (2)

  • Proportion of children who cleared parasites carrying pfcrt-76T and pfmdr1-86Y alleles.

  • Prevalence of dhfr-51, 59, 108 and dhps-437, 540

Interventions

ChloroquineDRUG

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre National de Recherche et de Formation sur le Paludisme

Ouagadougou, Kadiogo, 2208, Burkina Faso

Location

MeSH Terms

Conditions

Malaria

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

July 1, 2002

Study Completion

December 1, 2002

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

BU(1)