Penicillin Prophylaxis in Sickle Cell Disease (PROPS)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000585
First received: October 27, 1999
Last updated: June 23, 2005
Last verified: October 1994
  Purpose

To determine whether the regular daily administration of oral penicillin would reduce the incidence of documented infection due to Streptococcus pneumoniae in children with sickle cell anemia.


Condition Intervention Phase
Anemia, Sickle Cell
Hematologic Diseases
Hemoglobinopathies
Infection (S. Pneumoniae)
Pneumonia
Drug: penicillin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: August 1983
Estimated Study Completion Date: October 1994
Detailed Description:

BACKGROUND:

For over 20 years children with sickle cell anemia have been known to have an increased susceptibility to severe bacterial infection, particularly due to Streptococcus pneumoniae. Meningitis, pneumonia and septicemia due to this organism have been recognized as the major causes of death for these children, with children under three years of age being at highest risk. The annual incidence of pneumococcal septicemia among young children with sickle cell anemia appears to have remained remarkably constant over the last two decades at approximately 10 percent. This illness can often be fulminant, progressing from the onset of fever to death in less than 12 hours, with a case fatality rate ranging as high as 35 percent.

Penicillin prophylaxis has been advocated as a preventive measure against severe pneumococcal infections in children with sickle cell anemia. One study had shown that the risk of pneumococcal infection in these children could be reduced by the use of parenteral penicillin.

DESIGN NARRATIVE:

Phase I was a multi-center, randomized, double-blind, placebo-controlled trial. One hundred and five patients were assigned to the penicillin group and 110 to placebo. The primary endpoint was a documented severe infection due to S. pneumoniae. The secondary endpoint was a severe infection due to an organism other than S. pneumoniae.

Because data were not available to define the age at which prophylactic penicillin could be safely discontinued, the NHLBI launched Phase II of the Prophylactic Penicillin Study beginning in 1987. Recruitment ended in August, 1993. The clinical phase of Phase II ended in August, 1994.

Phase II was a multi-center randomized trial to evaluate the hazards of discontinuing daily oral penicillin at the age of five years. Within three months of their fifth birthdays, all children were randomized to continue oral penicillin prophylaxis or to stop prophylaxis. Each child was followed for a minimum of two years. The primary endpoint was a comparison of documented pneumococcal infection in children continuing penicillin after five years of age versus children whose prophylaxis was stopped at five years of age. Ancillary studies conducted in subsets of patients included: the prevalence of colonization of the nasopharynx with antibiotic resistant microorangisms; and the relationship of antibody response to pneumococcal vaccination to the incidence of pneumococcal sepsis in this patient population.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

In the Phase I trial, Black children with sickle cell anemia aged 3 months to 3 years. In the Phase II trial, children with sickle cell anemia aged five years 3 months of age and younger who had received prophylactic penicillin for at least two yea

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000585

Sponsors and Collaborators
Investigators
Investigator: David Becton University of Arkansas
Investigator: Ann Bjornson Gamble Institute of Medical Research
Investigator: George Buchanan University of Texas
Investigator: Neil Grossman Children's Hospital Medical Center, Cincinnati
Investigator: C. Holbrook East Carolina University School of Medicine
Investigator: Rathyi Iyer University of Mississippi Medical Center
Investigator: Karen Kalinyak Children's Hospital Medical Center, Cincinnati
Investigator: Thomas Kinney Duke University
Investigator: Helen Maurer University of Illinois at Chicago
Investigator: Scott Miller New York Health Science Center
Investigator: Charles Pegelow University of Miami
Investigator: Sergio Piomelli Columbia University
Investigator: Gregory Reaman Children's Hospital National Medical Center
Investigator: Alan Schwartz Washington University School of Medicine
Investigator: Elliott Vichinsky Children's Hospital Medical Center
Investigator: Winfred Wang St. Jude Children's Research Hospital
Investigator: Doris Wethers St. Luke's Roosevelt Institute of Health Science
Investigator: Gerald Woods Children's Mercy Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000585     History of Changes
Other Study ID Numbers: 305
Study First Received: October 27, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Hemoglobinopathies
Pneumonia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Genetic Diseases, Inborn
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 16, 2014