NCT00209794

Brief Summary

To evaluate if intermittent preventive treatment in infants (IPTi) consisting of SP \[Fansidar\] given through the EPI scheme alongside routine immunisations at 3, 4 and 9 months of age reduces de incidence of clinical malaria up to 12 months of age

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,498

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2002

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

November 16, 2006

Status Verified

November 1, 2006

First QC Date

September 13, 2005

Last Update Submit

November 15, 2006

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • Incidence of first or only malaria episodes in each study cohort by 12 months of age.

Secondary Outcomes (11)

  • Incidence of first or only malaria episodes by group up to 12 months of age as per protocol analysis.

  • Incidence of first or only malaria episodes by group up to 24 months of age.

  • Incidence of multiple malaria episodes up to 12 months of age.

  • Incidence of multiple malaria episodes up to 24 months of age.

  • Incidence of overall and severe anaemia up to 12 months of age.

  • +6 more secondary outcomes

Interventions

Sulfadoxine-Pyrimethamine (Fansidar)DRUG

Eligibility Criteria

AgeUp to 3 Months
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Children from study area
  • Signed informed consent

You may not qualify if:

  • History of drug allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Investigaçao em Saude da Manhiça

Manhiça, Maputo Province, Mozambique

Location

Related Publications (1)

  • Mayor A, Serra-Casas E, Sanz S, Aponte JJ, Macete E, Mandomando I, Puyol L, Berzosa P, Dobano C, Aide P, Sacarlal J, Benito A, Alonso P, Menendez C. Molecular markers of resistance to sulfadoxine-pyrimethamine during intermittent preventive treatment for malaria in Mozambican infants. J Infect Dis. 2008 Jun 15;197(12):1737-42. doi: 10.1086/588144.

    PMID: 18419347DERIVED

Related Links

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Clara Menendez, MD, PhD

    Center for International Health, Hospital Clinic de Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

September 1, 2002

Study Completion

December 1, 2005

Last Updated

November 16, 2006

Record last verified: 2006-11

Locations

MO(1)