A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children - Full Text View

Purpose

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.

Condition	Intervention
Malaria	Drug: Intermittent preventive treatment with AQ+ SP

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine

U.S. FDA Resources

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:

Incidence of clinical malaria [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	6000
Study Start Date:	August 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2 Amodiaquine+pyrimethamine versus placebo	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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	3 Months to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738946

Locations

Burkina Faso
Centre National de Recherche et de Formation sur le Paludisme
Ouagadougou, Kadiogo, Burkina Faso, BP 2208
Mali
Malaria Research and Training Centre
Bamako, Mali

Sponsors and Collaborators

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

Investigators

Study Director:

Brian M Greenwood, MD, FRCP

London School of Hygiene and Tropical Medicine

More Information

No publications provided by London School of Hygiene and Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Konaté AT, Yaro JB, Ouédraogo AZ, Diarra A, Gansané A, Soulama I, Kangoyé DT, Kaboré Y, Ouédraogo E, Ouédraogo A, Tiono AB, Ouédraogo IN, Chandramohan D, Cousens S, Milligan PJ, Sirima SB, Greenwood BM, Diallo DA. Morbidity from malaria in children in the year after they had received intermittent preventive treatment of malaria: a randomised trial. PLoS One. 2011;6(8):e23391. Epub 2011 Aug 12.

Dicko A, Barry A, Dicko M, Diallo AI, Tembine I, Dicko Y, Dara N, Sidibe Y, Santara G, Conaré T, Chandramohan D, Cousens S, Milligan PJ, Diallo DA, Doumbo OK, Greenwood B. Malaria morbidity in children in the year after they had received intermittent preventive treatment of malaria in Mali: a randomized control trial. PLoS One. 2011;6(8):e23390. Epub 2011 Aug 12.

Konaté AT, Yaro JB, Ouédraogo AZ, Diarra A, Gansané A, Soulama I, Kangoyé DT, Kaboré Y, Ouédraogo E, Ouédraogo A, Tiono AB, Ouédraogo IN, Chandramohan D, Cousens S, Milligan PJ, Sirima SB, Greenwood B, Diallo DA. Intermittent preventive treatment of malaria provides substantial protection against malaria in children already protected by an insecticide-treated bednet in Burkina Faso: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 Feb 1;8(2):e1000408.

Dicko A, Diallo AI, Tembine I, Dicko Y, Dara N, Sidibe Y, Santara G, Diawara H, Conaré T, Djimde A, Chandramohan D, Cousens S, Milligan PJ, Diallo DA, Doumbo OK, Greenwood B. Intermittent preventive treatment of malaria provides substantial protection against malaria in children already protected by an insecticide-treated bednet in Mali: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 Feb 1;8(2):e1000407.

Responsible Party:	Professor Brian Greenwood, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT00738946 History of Changes
Obsolete Identifiers:	NCT00745979
Other Study ID Numbers:	IPTCVP17
Study First Received:	August 20, 2008
Last Updated:	June 3, 2010
Health Authority:	United Kingdom: Research Ethics Committee Mali: Ministry of Health Burkina Faso: Ministry of Health

Keywords provided by London School of Hygiene and Tropical Medicine:

Intermittent Preventive treatment
insecticide treated bednets
malaria

Additional relevant MeSH terms:

Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013

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