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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623155
• Other study ID #: A10828
• Status: Completed
• Phase: N/A
• First received: February 14, 2008
• Last updated: February 22, 2008
• Start date: July 2002
• Est. completion date: January 2004

Study information

• Verified date: September 2002
• Source: University of Bamako
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mali: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: January 2004
• Est. primary completion date: July 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

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.

Locations

Country	Name	City	State
Mali	Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako	Bamako

Sponsors (2)

Lead Sponsor	Collaborator
University of Bamako	World Health Organization

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence rate of clinical malaria			No
Primary	in vivo adequate clinical and parasitological response of P. falciparum to SP			No