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Penicillin Prophylaxis in Sickle Cell Disease (PROPS)

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ClinicalTrials.gov Identifier: NCT00000585
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : March 25, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE October 27, 1999
First Posted Date  ICMJE October 28, 1999
Last Update Posted Date March 25, 2016
Study Start Date  ICMJE August 1983
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00000585 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Penicillin Prophylaxis in Sickle Cell Disease (PROPS)
Official Title  ICMJE Not Provided
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Anemia, Sickle Cell
  • Hematologic Diseases
  • Hemoglobinopathies
  • Infection (S. Pneumoniae)
  • Pneumonia
Intervention  ICMJE Drug: penicillin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE October 1994
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000585
Other Study ID Numbers  ICMJE 305
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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 Kansas City
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date October 1994

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