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A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children (IPTc/ITNs)

This study has been completed.
Sponsor:
Collaborators:
Centre National de Recherche et de Formation sur le Paludisme, Burkina Faso
Malaria Research and Training Centre, Mali
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00738946
First received: August 20, 2008
Last updated: June 3, 2010
Last verified: June 2010
History of Changes

August 20, 2008
June 3, 2010
August 2008
December 2008   (final data collection date for primary outcome measure)
Incidence of clinical malaria [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]
Incidence of malaria [ Time Frame: 2008-2009 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00738946 on ClinicalTrials.gov Archive Site
Incidence of severe malaria, Incidence of anemia, Prevalence of anemia, Prevalence of parasitemia, Proportion of children with parasites carrying resistance markers to AQ and SP, Incidence of hospital admissions due to malaria. [ Time Frame: 2008-2009 ] [ Designated as safety issue: Yes ]
Incidence of clinical malaria, any parasite density. Incidence of severe malaria. Prevalence of parasitemia. Prevalence of anemia. Prevalence of genetic markers of resistance to SP and AQ. Incidence of hospital admissions due to malaria. [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children
A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children

An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.

The trial will be conducted in 6000 children in Burkina Faso and Mali in 2008 and 2009. Each site will enroll 3,000 children. All children will be allocated a long lasting insecticide-treated net and randomized to receive to treatment (amodiaquine + sulfadoxine-pyrimethamine (AQ+SP)) or placebo (AQ-placebo + SP-placebo. Treatment will be administered over 3 rounds during the high malaria transmission season, with one month interval between rounds. Full course treatment of AQ and SP will be administered on each occasion. Treatment will not be given in the second year. Passive surveillance of malaria will be implemented for the monitoring of malaria morbidity and to assess whether children who received intermittent preventive treatment (IPT) are at increased risk of malaria. Adverse events will be monitored during each round of IPT administration. To assess the effect of IPTc on the prevalence of malaria infection, a random sample of 150 children will be visited every week during the high malaria transmission period. This number will be increased to 300 during the low transmission season, but the survey will be reduced to monthly visits. Baseline prevalence of genetic markers of resistance to SP and AQ will be estimated. A second cross-sectional survey will be conducted at the end of the malaria transmission season to assess the effect of IPT on the prevalence of genetic markers of resistance to SP and AQ, on the prevalence of anaemia and on nutritional indicators.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Malaria
Drug: Intermittent preventive treatment with AQ+ SP
Amodiaquine (10 mg/kg over 3 days) and Sulfadoxine Pyrimethamine (25 mg of sulfadoxine + 1.25 mg of pyrimethamine per kg in a single dose) or placebo administered over 3 rounds of one month interval
Other Name: IPTc
Experimental: 2
Amodiaquine+pyrimethamine versus placebo
Intervention: Drug: Intermittent preventive treatment with AQ+ SP

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6000
December 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Permanent residence in the study area with no intention of leaving during the surveillance period.
  • Obtention of informed consent.

Exclusion Criteria:

  • Temporary residence in the study area.
  • Absence of informed consent.
  • Presence of a severe, chronic illness such as severe malnutrition (Kwashiorkor or marasmus) or AIDS, likely to interfere with evaluation of the trial results.
  • A history of a previous, significant adverse reaction to either of the study drugs.
Both
3 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso,   Mali
 
NCT00738946
IPTCVP17
Yes
Professor Brian Greenwood, London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
  • Centre National de Recherche et de Formation sur le Paludisme, Burkina Faso
  • Malaria Research and Training Centre, Mali
Study Director: Brian M Greenwood, MD, FRCP London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP