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

NCT ID: NCT00623155

Last Updated: 2008-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2004-01-31

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Test group

Group Type: EXPERIMENTAL

Seasonal IPT in children - Sulfadoxine-pyrimethamine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

University of Bamako

OTHER

Sponsor Role: lead

Responsible Party

Faculty of Medicine, Pharmacy and Dentistry, University of Bamako

Principal Investigators

Ogobara Doumbo, MD

Role: STUDY_DIRECTOR

University of Bamako

Alassane Dicko, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bamako

Locations

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

Bamako, , Mali

Countries

Mali

References

Dicko A, Sagara I, Sissoko MS, Guindo O, Diallo AI, Kone M, Toure OB, Sacko M, Doumbo OK. Impact of intermittent preventive treatment with sulphadoxine-pyrimethamine targeting the transmission season on the incidence of clinical malaria in children in Mali. Malar J. 2008 Jul 8;7:123. doi: 10.1186/1475-2875-7-123.

Reference Type: DERIVED

PMID: 18611271 (View on PubMed)

Other Identifiers

A10828

Identifier Type: -

Identifier Source: org_study_id