Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00623155
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : February 25, 2008
World Health Organization
Information provided by:
University of Bamako

Brief Summary:
Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.

Condition or disease Intervention/treatment Phase
Malaria Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management
Study Start Date : July 2002
Actual Primary Completion Date : July 2003
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
No Intervention: 1
Control group
Experimental: 2
Test group
Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine
Subjecs randomized to receive two intermittent preventive treatments with standard recommended treatment doses of Sulfadoxine-pyrimethamine at 8 weeks interval during the peak malaria transmission season.

Primary Outcome Measures :
  1. incidence rate of clinical malaria
  2. in vivo adequate clinical and parasitological response of P. falciparum to SP

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 6 months to 10 years
  • Agree to seek initial medical care for all medical illness in the study clinic during the study period
  • Written informed consent by a parent or legal garden,
  • No plan to travel for a long time during the study period.

Exclusion Criteria:

  • History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
  • Chronic illness or symptomatic malaria at the time of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00623155

Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako
Bamako, Mali
Sponsors and Collaborators
University of Bamako
World Health Organization
Study Director: Ogobara Doumbo, MD University of Bamako
Principal Investigator: Alassane Dicko, MD University of Bamako

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Alassane Dicko, Faculty of Medicine, Pharmacy and Dentistry, University of Bamako Identifier: NCT00623155     History of Changes
Other Study ID Numbers: A10828
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: February 25, 2008
Last Verified: September 2002

Keywords provided by University of Bamako:
intermittent preventive treatment

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents