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IPTi in Mozambican Infants for Malaria Prevention
This study is ongoing, but not recruiting participants.
Sponsored by: Hospital Clinic of Barcelona
Information provided by: Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00209794
  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 I
Phase II

MedlinePlus related topics: Malaria
Drug Information available for: Pyrimethamine Sulfadoxine Fansidar
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children

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

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Children from study area
  • Signed informed consent

Exclusion Criteria:

  • History of drug allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209794

Locations
Mozambique, Maputo
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

Related Info  This link exits the ClinicalTrials.gov site

Publications indexed to this study:
Study ID Numbers: TIM
Study First Received: September 13, 2005
Last Updated: November 15, 2006
ClinicalTrials.gov Identifier: NCT00209794  
Health Authority: Mozambique: Ministry of Health (MISAU)

Study placed in the following topic categories:
Folic Acid
Pyrimethamine
Protozoan Infections
Sulfadoxine-pyrimethamine
Parasitic Diseases
Malaria
Sulfadoxine

Additional relevant MeSH terms:
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Coccidiosis
Therapeutic Uses
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009