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Penicillin Prophylaxis in Sickle Cell Disease (PROPS)

Primary Purpose

Anemia, Sickle Cell, Hematologic Diseases, Hemoglobinopathies

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
penicillin
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia, Sickle Cell

Eligibility Criteria

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    March 24, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000585
    Brief Title
    Penicillin Prophylaxis in Sickle Cell Disease (PROPS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 1994
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1983 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 1994 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Sickle Cell, Hematologic Diseases, Hemoglobinopathies, Infection (S. Pneumoniae), Pneumonia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    penicillin

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Becton
    Organizational Affiliation
    University of Arkansas
    First Name & Middle Initial & Last Name & Degree
    Ann Bjornson
    Organizational Affiliation
    Gamble Institute of Medical Research
    First Name & Middle Initial & Last Name & Degree
    George Buchanan
    Organizational Affiliation
    University of Texas
    First Name & Middle Initial & Last Name & Degree
    Neil Grossman
    Organizational Affiliation
    Children's Hospital Medical Center, Cincinnati
    First Name & Middle Initial & Last Name & Degree
    C. Holbrook
    Organizational Affiliation
    East Carolina University School of Medicine
    First Name & Middle Initial & Last Name & Degree
    Rathyi Iyer
    Organizational Affiliation
    University of Mississippi Medical Center
    First Name & Middle Initial & Last Name & Degree
    Karen Kalinyak
    Organizational Affiliation
    Children's Hospital Medical Center, Cincinnati
    First Name & Middle Initial & Last Name & Degree
    Thomas Kinney
    Organizational Affiliation
    Duke University
    First Name & Middle Initial & Last Name & Degree
    Helen Maurer
    Organizational Affiliation
    University of Illinois at Chicago
    First Name & Middle Initial & Last Name & Degree
    Scott Miller
    Organizational Affiliation
    New York Health Science Center
    First Name & Middle Initial & Last Name & Degree
    Charles Pegelow
    Organizational Affiliation
    University of Miami
    First Name & Middle Initial & Last Name & Degree
    Sergio Piomelli
    Organizational Affiliation
    Columbia University
    First Name & Middle Initial & Last Name & Degree
    Gregory Reaman
    Organizational Affiliation
    Children's Hospital National Medical Center
    First Name & Middle Initial & Last Name & Degree
    Alan Schwartz
    Organizational Affiliation
    Washington University School of Medicine
    First Name & Middle Initial & Last Name & Degree
    Elliott Vichinsky
    Organizational Affiliation
    Children's Hospital & Medical Center
    First Name & Middle Initial & Last Name & Degree
    Winfred Wang
    Organizational Affiliation
    St. Jude Children's Research Hospital
    First Name & Middle Initial & Last Name & Degree
    Doris Wethers
    Organizational Affiliation
    St. Luke's Roosevelt Institute of Health Science
    First Name & Middle Initial & Last Name & Degree
    Gerald Woods
    Organizational Affiliation
    Children's Mercy Hospital Kansas City

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    3086721
    Citation
    Gaston MH, Verter JI, Woods G, Pegelow C, Kelleher J, Presbury G, Zarkowsky H, Vichinsky E, Iyer R, Lobel JS, et al. Prophylaxis with oral penicillin in children with sickle cell anemia. A randomized trial. N Engl J Med. 1986 Jun 19;314(25):1593-9. doi: 10.1056/NEJM198606193142501.
    Results Reference
    background
    PubMed Identifier
    7472817
    Citation
    Falletta JM, Woods GM, Verter JI, Buchanan GR, Pegelow CH, Iyer RV, Miller ST, Holbrook CT, Kinney TR, Vichinsky E, et al. Discontinuing penicillin prophylaxis in children with sickle cell anemia. Prophylactic Penicillin Study II. J Pediatr. 1995 Nov;127(5):685-90. doi: 10.1016/s0022-3476(95)70154-0.
    Results Reference
    background
    PubMed Identifier
    8969724
    Citation
    Bjornson AB, Falletta JM, Verter JI, Buchanan GR, Miller ST, Pegelow CH, Iyer RV, Johnstone HS, DeBaun MR, Wethers DL, Wang WC, Woods GM, Holbrook CT, Becton DL, Kinney TR, Reaman GH, Kalinyak K, Grossman NJ, Vichinsky E, Reid CD. Serotype-specific immunoglobulin G antibody responses to pneumococcal polysaccharide vaccine in children with sickle cell anemia: effects of continued penicillin prophylaxis. J Pediatr. 1996 Dec;129(6):828-35. doi: 10.1016/s0022-3476(96)70026-4.
    Results Reference
    background
    PubMed Identifier
    9256832
    Citation
    Woods GM, Jorgensen JH, Waclawiw MA, Reid C, Wang W, Pegelow CH, Rogers ZR, Iyer RV, Holbrook CT, Kinney TR, Vichinsky E, DeBaun MR, Grossman NJ, Thomas MD, Falletta JM. Influence of penicillin prophylaxis on antimicrobial resistance in nasopharyngeal S. pneumoniae among children with sickle cell anemia. The Ancillary Nasopharyngeal Culture Study of Prophylactic Penicillin Study II. J Pediatr Hematol Oncol. 1997 Jul-Aug;19(4):327-33. doi: 10.1097/00043426-199707000-00011.
    Results Reference
    background
    PubMed Identifier
    2111933
    Citation
    Gaston MH, Verter J. Sickle cell anaemia trial. Stat Med. 1990 Jan-Feb;9(1-2):45-9; discussion 49-51. doi: 10.1002/sim.4780090111.
    Results Reference
    background

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    Penicillin Prophylaxis in Sickle Cell Disease (PROPS)

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