Prophylaxis With Oral Penicillin in Children With Sickle Cell Anemia: A Randomized Trial

Abstract

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 younger than 3 years of age at the time of entry. The children were randomly assigned to receive either 125 mg of penicillin 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% 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 v 2 of 105; P = .0025). There were no deaths from pneumococcal septicemia in the penicillin-treated group but three deaths from the infection occurred 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 4 months of age to decrease the morbidity and mortality [SEE FIGURE IN SOURCE PDF.] associated with pneumococcal septicemia. (Previously published in N Engl J Med 1986;314:1593-1599.

CDC Statement on Study Results of Product Containing Nonoxynol-9

“…Data from the 1988-1991 BRFSS projected that 31 of 47 states (Kansas, Nevada, and Wyoming were excluded) and DC would have cholesterol screening rates greater than the 2000 objective. 4 However, this report indicates that nine of 50 states and DC attained a cho-lesterol screening rate of Ն75% in 1999. In addition, 14 states had at least a 10% difference between the 2010 objective of 80% and the 2010 projected screening rates using the state-specific method.…”

“…The trend of decreasing cholesterol screening rates in seven states is of particular concern. In the 1988-1991 BRFSS analysis, 4 all states had increases in cholesterol screening rates. Changes in the sampling frame or weighting protocol within a state during the 9 years may have contributed to the decline.…”

“…* However, states did not widely adopt newborn screening for SCD until 1986, when results of a randomized trial demonstrated that oral penicillin significantly reduced SCD-related morbidity and mortality in children. 4 Results of this trial and statements from key organizations 5-7 resulted in adoption of newborn screening. In 2000, most states screen newborns for SCD.…”

Black Americans’ willingness to participate in pediatric sickle cell clinical trials: A retrospective, systematic review

“…Approximately one out of 365 African Americans have SCD and one in 13 African Americans carry the sickle trait 23 . Approximately 90% of individuals with SCD in the United States are African American, or of African descent 24–39 . Therefore, we conducted a retrospective analysis of 17 landmark randomized clinical trials (RCTs) pertinent to SCD from 1986 to 2018.…”

Maintenance of an Immunogenic Response to Pneumococcal Vaccination in Children With Sickle Cell Disease

“…4 This led to the initial use of the 7-valent pneumococcal conjugate vaccine (PCV7) in patients under 2 years of age, which was replaced with the 13-valent pneumococcal conjugate vaccine (PCV13) in 2010. [2][3][4] The Advisory Committee on Immunization Practices (ACIP) recommends all infants should complete a series of PCV13, typically completed by 15 months of age. PCV13 only covers a portion of the numerous strains of pneumococcal disease, however, the introduction of this vaccine was found to result in a 64% overall reduction in IPD.…”