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

This study has been completed.
Sponsor:
Collaborator:
World Health Organization
Information provided by:
University of Bamako
ClinicalTrials.gov Identifier:
NCT00623155
First received: February 14, 2008
Last updated: February 22, 2008
Last verified: September 2002
  Purpose

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 Intervention
Malaria
Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Bamako:

Primary Outcome Measures:
  • incidence rate of clinical malaria [ Designated as safety issue: No ]
  • in vivo adequate clinical and parasitological response of P. falciparum to SP [ Designated as safety issue: No ]

Enrollment: 262
Study Start Date: July 2002
Study Completion Date: January 2004
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623155

Locations
Mali
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
Investigators
Study Director: Ogobara Doumbo, MD University of Bamako
Principal Investigator: Alassane Dicko, MD University of Bamako
  More Information

No publications provided by University of Bamako

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Alassane Dicko, Faculty of Medicine, Pharmacy and Dentistry, University of Bamako
ClinicalTrials.gov Identifier: NCT00623155     History of Changes
Other Study ID Numbers: A10828
Study First Received: February 14, 2008
Last Updated: February 22, 2008
Health Authority: Mali: Ministry of Health

Keywords provided by University of Bamako:
malaria
intermittent preventive treatment
season
children

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on April 22, 2014