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Completed

NCT Number: NCT00623155

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

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.

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Key information

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako

Bamako, Mali

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seasonal IPT in children - Sulfadoxine-pyrimethamine

Drug

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 outcomes

  1. incidence rate of clinical malaria

  2. in vivo adequate clinical and parasitological response of P. falciparum to SP

Sponsors and collaborators

Lead sponsor

University of Bamako

Other

Collaborators

  • World Health Organization

Registry information

Official study title

Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management

Important dates

Study start
2002
Primary completion
2003
Study completion
2004
First posted
Feb 25, 2008
Registry last updated
Feb 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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