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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
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

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.

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

Detailed Description:


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.


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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Study Start Date : August 1983
Study Completion Date : October 1994

Resource links provided by the National Library of Medicine

Drug Information available for: Penicillins

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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)
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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 Kansas City

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ClinicalTrials.gov Identifier: NCT00000585    
Other Study ID Numbers: 305
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: October 1994
Additional relevant MeSH terms:
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Hematologic Diseases
Anemia, Sickle Cell
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anti-Bacterial Agents
Anti-Infective Agents