NCT00623155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
Last Updated

February 25, 2008

Status Verified

September 1, 2002

Enrollment Period

1 year

First QC Date

February 14, 2008

Last Update Submit

February 22, 2008

Conditions

Malaria

Keywords

malariaintermittent preventive treatmentseasonchildren

Outcome Measures

Primary Outcomes (2)

  • incidence rate of clinical malaria

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

Study Arms (2)

1

NO INTERVENTION

Control group

2

EXPERIMENTAL

Test group

Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine

Interventions

Seasonal IPT in children - Sulfadoxine-pyrimethamineDRUG

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.

2

Eligibility Criteria

Age6 Months - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bamako, Mali

Location

Related Publications (1)

  • 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.

    PMID: 18611271DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Ogobara Doumbo, MD

    University of Bamako

    STUDY DIRECTOR

  • Alassane Dicko, MD

    University of Bamako

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 25, 2008

Study Start

July 1, 2002

Primary Completion

July 1, 2003

Study Completion

January 1, 2004

Last Updated

February 25, 2008

Record last verified: 2002-09

Locations

MA(1)