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Prophylaxis with oral penicillin in children with sickle cell anemia. A randomized trial.

Publication ,  Journal Article
Gaston, MH; Verter, JI; Woods, G; Pegelow, C; Kelleher, J; Presbury, G; Zarkowsky, H; Vichinsky, E; Iyer, R; Lobel, JS
Published in: N Engl J Med
June 19, 1986

Children with sickle cell anemia have an increased susceptibility to bacterial infections, especially to those caused by Streptococcus pneumoniae. We therefore conducted a multicenter, randomized, double-blind, placebo-controlled clinical trial to test whether the regular, daily administration of oral penicillin would reduce the incidence of documented septicemia due to S.pneumoniae in children with sickle cell anemia who were under the age of three years at the time of entry. The children were randomly assigned to receive either 125 mg of penicillin V potassium (105 children) or placebo (110 children) twice daily. The trial was terminated 8 months early, after an average of 15 months of follow-up, when an 84 percent reduction in the incidence of infection was observed in the group treated with penicillin, as compared with the group given placebo (13 of 110 patients vs. 2 of 105; P = 0.0025), with no deaths from pneumococcal septicemia occurring in the penicillin group but three deaths from the infection occurring in the placebo group. On the basis of these results, we conclude that children should be screened in the neonatal period for sickle cell hemoglobinopathy and that those with sickle cell anemia should receive prophylactic therapy with oral penicillin by four months of age to decrease the morbidity and mortality associated with pneumococcal septicemia.

Duke Scholars

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Published In

N Engl J Med

DOI

ISSN

0028-4793

Publication Date

June 19, 1986

Volume

314

Issue

25

Start / End Page

1593 / 1599

Location

United States

Related Subject Headings

  • Sepsis
  • Random Allocation
  • Pneumococcal Infections
  • Penicillin V
  • Male
  • Infant
  • Humans
  • General & Internal Medicine
  • Female
  • Double-Blind Method
 

Citation

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Gaston, M. H., Verter, J. I., Woods, G., Pegelow, C., Kelleher, J., Presbury, G., … Lobel, J. S. (1986). Prophylaxis with oral penicillin in children with sickle cell anemia. A randomized trial. N Engl J Med, 314(25), 1593–1599. https://doi.org/10.1056/NEJM198606193142501
Gaston, M. H., J. I. Verter, G. Woods, C. Pegelow, J. Kelleher, G. Presbury, H. Zarkowsky, E. Vichinsky, R. Iyer, and J. S. Lobel. “Prophylaxis with oral penicillin in children with sickle cell anemia. A randomized trial.N Engl J Med 314, no. 25 (June 19, 1986): 1593–99. https://doi.org/10.1056/NEJM198606193142501.
Gaston MH, Verter JI, Woods G, Pegelow C, Kelleher J, Presbury G, 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.
Gaston, M. H., et al. “Prophylaxis with oral penicillin in children with sickle cell anemia. A randomized trial.N Engl J Med, vol. 314, no. 25, June 1986, pp. 1593–99. Pubmed, doi:10.1056/NEJM198606193142501.
Gaston MH, Verter JI, Woods G, Pegelow C, Kelleher J, Presbury G, Zarkowsky H, Vichinsky E, Iyer R, Lobel JS. Prophylaxis with oral penicillin in children with sickle cell anemia. A randomized trial. N Engl J Med. 1986 Jun 19;314(25):1593–1599.
Journal cover image

Published In

N Engl J Med

DOI

ISSN

0028-4793

Publication Date

June 19, 1986

Volume

314

Issue

25

Start / End Page

1593 / 1599

Location

United States

Related Subject Headings

  • Sepsis
  • Random Allocation
  • Pneumococcal Infections
  • Penicillin V
  • Male
  • Infant
  • Humans
  • General & Internal Medicine
  • Female
  • Double-Blind Method