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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
September 13, 2005
September 21, 2005
November 16, 2006
September 2002
Not Provided
Incidence of first or only malaria episodes in each study cohort by 12 months of age.
Same as current
Complete list of historical versions of study NCT00209794 on ClinicalTrials.gov Archive Site
  • 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.
  • 1. Incidence of first or only malaria episodes by group up to 12 months of age as per protocol analysis.
  • 2. Incidence of first or only malaria episodes by group up to 24 months of age.
  • 3. Incidence of multiple malaria episodes up to 12 months of age.
  • 4. Incidence of multiple malaria episodes up to 24 months of age.
  • 5. Incidence of overall and severe anaemia up to 12 months of age.
  • 6. Incidence of overall and severe anaemia up to 24 months of age.
  • 7. Proportion of humoral and cellular immune responses against malaria at 12 months of age.
  • 8. Total number of admissions and outpatient attendances up to 24 months of age.
  • 9. Prevalence of P falciparum parasitaemia and overall and severe anaemia at 12 months of age.
  • 10. 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
  • 11. Incidence of side effects in each group up to 12 months of age.
Not Provided
Not Provided
 
IPTi in Mozambican Infants for Malaria Prevention
The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children
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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Malaria
Drug: Sulfadoxine-Pyrimethamine (Fansidar)
Not Provided
Mayor A, Serra-Casas E, Sanz S, Aponte JJ, Macete E, Mandomando I, Puyol L, Berzosa P, Dobaño C, Aide P, Sacarlal J, Benito A, Alonso P, Menéndez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1498
December 2005
Not Provided

Inclusion Criteria:

  • Children from study area
  • Signed informed consent

Exclusion Criteria:

  • History of drug allergies
Sexes Eligible for Study: All
up to 3 Months   (Child)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Mozambique
 
 
NCT00209794
TIM
Not Provided
Not Provided
Not Provided
Not Provided
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Clara Menendez, MD, PhD Center for International Health, Hospital Clinic de Barcelona
Hospital Clinic of Barcelona
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP