Penicillin Prophylaxis in Sickle Cell Disease (PROPS)

NCT00000585 | Completed Phase 3

• 1 other identifier: 305
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia, Sickle Cell; Hematologic Diseases; Hemoglobinopathies; Infection (S. Pneumoniae); Pneumonia

Interventions

penicillin DRUG

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (5)

• 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.

  PMID: 3086721 BACKGROUND

• 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.

  PMID: 7472817 BACKGROUND

• 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.

  PMID: 8969724 BACKGROUND

• 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.

  PMID: 9256832 BACKGROUND

• 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.

  PMID: 2111933 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Hematologic Diseases; Hemoglobinopathies; Infections; Pneumonia

Interventions

Penicillins

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David Becton

  University of Arkansas

• Ann Bjornson

  Gamble Institute of Medical Research

• George Buchanan

  University of Texas

• Neil Grossman

  Children's Hospital Medical Center, Cincinnati

• C. Holbrook

  East Carolina University School of Medicine

• Rathyi Iyer

  University of Mississippi Medical Center

• Karen Kalinyak

  Children's Hospital Medical Center, Cincinnati

• Thomas Kinney

  Duke University

• Helen Maurer

  University of Illinois at Chicago

• Scott Miller

  New York Health Science Center

• Charles Pegelow

  University of Miami

• Sergio Piomelli

  Columbia University

• Gregory Reaman

  Children's Hospital National Medical Center

• Alan Schwartz

  Washington University School of Medicine

• Elliott Vichinsky

  Children's Hospital & Medical Center

• Winfred Wang

  St. Jude Children's Research Hospital

• Doris Wethers

  St. Luke's Roosevelt Institute of Health Science

• Gerald Woods

  Children's Mercy Hospital Kansas City

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: August 1, 1983
• Study Completion: October 1, 1994
• Last Updated: March 25, 2016

Record last verified: 1994-10