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COMPLETE RECORD
Citation
4.
Unique Identifier
96060897
Authors
Falletta JM. Woods GM. Verter JI. Buchanan GR. Pegelow CH. Iyer RV. Miller ST. Holbrook CT. Kinney TR. Vichinsky E. et al.
Institution
Division of Pediatric Hematology-Oncology, Duke Comprehensive
Sickle
Cell
Center, Duke University Medical Center, Durham, North Carolina 27710, USA.
Title
Discontinuing penicillin
prophyla
xis in children with
sickle
cell
anemia.
Prophyla
ctic Penicillin Study II.
Source
Journal of Pediatrics. 127(5):685-90, 1995 Nov.
NLM Journal Code
jlz, JLZ
Journal Subset
A, C
Country of Publication
United States
MeSH Subject Headings
The Complete Record displays the MeSH terms assigned to the article. These can suggest additional terms for your search strategy.
Anemia, Sickle Cell / co [Complications]
*Anemia, Sickle Cell / th [Therapy]
Bacteremia / et [Etiology]
Bacteremia / pc [Prevention & Control]
Bacterial Vaccines / im [Immunology]
Child, Preschool
Comparative Study
Double-Blind Method
Female
Human
Male
Meningitis, Pneumococcal / et [Etiology]
Meningitis, Pneumococcal / pc [Prevention & Control]
Penicillins / ae [Adverse Effects]
*Penicillins / tu [Therapeutic Use]
Pneumococcal Infections / et [Etiology]
Pneumococcal Infections / pc [Prevention & Control]
Streptococcus pneumoniae / im [Immunology]
Support, U.S. Gov't, P.H.S.
Time Factors
Treatment Outcome
United States
Abstract
OBJECTIVE:
To evaluate the consequences of discontinuing penicillin
prophyla
xis at 5 years of age in children with
sickle
cell
anemia who had received
prophyla
ctic penicillin for much of their lives.
DESIGN:
Randomized, double-blind, placebo-controlled trial.
SETTING:
Eighteen teaching hospitals throughout the United States.
PATIENTS:
Children with
sickle
cell
anemia (hemoglobin SS or hemoglobin S beta 0-thalassemia) who had received
prophyla
ctic penicillin therapy for at least 2 years immediately before their fifth birthday and had received the 23-valent pneumococcal vaccine between 2 and 3 years of age and again at the time of randomization. Of 599 potential candidates, 400 were randomly selected and followed for an average of 3.2 years.
INTERVENTIONS:
After randomization, patients received the study medication twice daily--either penicillin V potassium, 250 mg, or an identical placebo tablet. Patients were either seen in the clinic or contacted every 3 months thereafter for an interval history and dispensing of the study drug. A physical examination was scheduled every 6 months.
MAIN OUTCOME MEASURES:
The primary end point was a comparison of the incidence of bacteremia or meningitis caused by Streptococcus pneumoniae in children continuing penicillin
prophyla
xis versus those receiving the placebo.
RESULTS:
Six children had a systemic infection caused by S. pneumoniae, four in the placebo group (2.0%; 95% confidence interval 0.5%, 5.0%) and two in the continued penicillin
prophyla
xis group (1.0%; 95% confidence interval 0.1%, 3.6%) with a relative risk of 0.5 (95% confidence interval 0.1, 2.7). All invasive isolates were either serotype 6(A or B) or serotype 23F. Four of the isolates were penicillin susceptible, and two (one from each treatment group) were penicillin and multiply antibiotic resistant. Adverse effects of the study drug were reported for three patients (nausea, vomiting, or both), one of whom was in the placebo group.
CONCLUSION:
Children with
sickle
cell
anemia who have not had a prior severe pneumococcal infection or a splenectomy and are receiving comprehensive care may safely stop
prophyla
ctic penicillin therapy at 5 years of age. Parents must be aggressively counseled to seek medical attention for all febrile events in children with
sickle
cell
anemia.
Registry Numbers
0 (Bacterial Vaccines). 0 (
Penicillins
).
ISSN
0022-3476
Publication Type
Clinical Trial. Journal Article. Multicenter Study. Randomized Controlled Trial.
Language
English
Entry Month
199602.
Copyright (c) 2000 Ovid Technologies, Inc.
Version: rel4.2.0, SourceID: 1.4668.1.203
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