Prophylaxis with oral penicillin in children with sickle cell anemia. A randomized trial.
M H Gaston, J I Verter, G Woods...
https://pubmed.ncbi.nlm.nih.gov/3086721Completed
Phase 3
Age: 0 - 5Years
All Genders
ID00000585
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2016-03-25
N/A
Participants Needed
N/A
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Penicillin Prophylaxis in Sickle Cell Disease (PROPS)
Who Can Participate
Age: 0 - 5Years
All Genders
Eligibility Criteria
You may qualify if you...
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
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Site Locations not provided
Location information for this trial is currently unavailable.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
N/A
Primary Purpose
PREVENTION
Number of Arms
0
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Published Research Related To This Trial
Discontinuing penicillin prophylaxis in children with sickle cell anemia. Prophylactic Penicillin Study II.
J M Falletta, G M Woods, J I Verter...
https://pubmed.ncbi.nlm.nih.gov/7472817Serotype-specific immunoglobulin G antibody responses to pneumococcal polysaccharide vaccine in children with sickle cell anemia: effects of continued penicillin prophylaxis.
A B Bjornson, J M Falletta, J I Verter...
https://pubmed.ncbi.nlm.nih.gov/8969724Influence 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.
G M Woods, J H Jorgensen, M A Waclawiw...
https://pubmed.ncbi.nlm.nih.gov/9256832Sickle cell anaemia trial.
M H Gaston, J Verter
https://pubmed.ncbi.nlm.nih.gov/2111933