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IPTi in Mozambican Infants for Malaria Prevention

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Hospital Clinic of Barcelona.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209794
First Posted: September 21, 2005
Last Update Posted: November 16, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Clinic of Barcelona
  Purpose
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

Condition Intervention Phase
Malaria Drug: Sulfadoxine-Pyrimethamine (Fansidar) Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

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

Secondary Outcome Measures:
  • 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.
  • Incidence of overall and severe anaemia up to 24 months of age.
  • Proportion of humoral and cellular immune responses against malaria at 12 months of age.
  • Total number of admissions and outpatient attendances up to 24 months of age.
  • Prevalence of P falciparum parasitaemia and overall and severe anaemia at 12 months of age.
  • Proportion of humoral responses and geometric mean antibody titres of polio, DTP and Hepatitis B at 5 months and of measles at 9 and 12 months
  • Incidence of side effects in each group up to 12 months of age.

Estimated Enrollment: 1498
Study Start Date: September 2002
Estimated Study Completion Date: December 2005
Detailed Description:

The study is a randomised, double blind, placebo-controlled trial of the antimalarial drug sulphadoxine-pyrimethamine administered intermittently at 3, 4 and 9 months of age through the EPI scheme at the time of routine immunisations.

Children will be randomized into placebo and SP treatment groups by block randomization, and it is expected a similar age distribution and a similar number of children in each group.

Doses of sulphadoxine (25 mg/kg)-pyrimethamine (1.25 mg/kg) (SP) or placebo will be given by a health assistant according to bodyweight (a quarter of a tablet for those <5kg, a half for those 5-10 kg, and a whole tablet for children >10 kg). The tablets will be crashed and diluted with water for their administration.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Children from study area
  • Signed informed consent

Exclusion Criteria:

  • History of drug allergies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209794


Locations
Mozambique
Centro de Investigaçao em Saude da Manhiça
Manhiça, Maputo, Mozambique
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Clara Menendez, MD, PhD Center for International Health, Hospital Clinic de Barcelona
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00209794     History of Changes
Other Study ID Numbers: TIM
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: November 16, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents