We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Penicillin Prophylaxis in Sickle Cell Disease (PROPS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000585
First Posted: October 28, 1999
Last Update Posted: March 25, 2016
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:
National Heart, Lung, and Blood Institute (NHLBI)
  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
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000585


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

Publications:
ClinicalTrials.gov Identifier: NCT00000585     History of Changes
Other Study ID Numbers: 305
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: March 25, 2016
Last Verified: October 1994

Additional relevant MeSH terms:
Pneumonia
Hematologic Diseases
Hemoglobinopathies
Anemia, Sickle Cell
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Genetic Diseases, Inborn
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents