Home | All trials

[RDF data]
Trial NCT00000585

Resource URI: http://static.linkedct.org/resource/trials/NCT00000585
PropertyValue
linkedct:brief_title Penicillin Prophylaxis in Sickle Cell Disease (PROPS)
linkedct:condition <http://static.linkedct.org/resource/condition/10215>
linkedct:condition <http://static.linkedct.org/resource/condition/5761>
linkedct:condition <http://static.linkedct.org/resource/condition/5803>
linkedct:condition <http://static.linkedct.org/resource/condition/6583>
linkedct:condition <http://static.linkedct.org/resource/condition/943>
linkedct:criteria 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
linkedct:description BACKGROUND: For over 20 years children with sickle cell anemia have been known to have an increased susceptibility to severe bacterial infection, particularly due to Streptococcus pneumoniae. Meningitis, pneumonia and septicemia due to this organism have been recognized as the major causes of death for these children, with children under three years of age being at highest risk. The annual incidence of pneumococcal septicemia among young children with sickle cell anemia appears to have remained remarkably constant over the last two decades at approximately 10 percent. This illness can often be fulminant, progressing from the onset of fever to death in less than 12 hours, with a case fatality rate ranging as high as 35 percent. Penicillin prophylaxis has been advocated as a preventive measure against severe pneumococcal infections in children with sickle cell anemia. One study had shown that the risk of pneumococcal infection in these children could be reduced by the use of parenteral penicillin. DESIGN NARRATIVE: Phase I was a multi-center, randomized, double-blind, placebo-controlled trial. One hundred and five patients were assigned to the penicillin group and 110 to placebo. The primary endpoint was a documented severe infection due to S. pneumoniae. The secondary endpoint was a severe infection due to an organism other than S. pneumoniae. Because data were not available to define the age at which prophylactic penicillin could be safely discontinued, the NHLBI launched Phase II of the Prophylactic Penicillin Study beginning in 1987. Recruitment ended in August, 1993. The clinical phase of Phase II ended in August, 1994. Phase II was a multi-center randomized trial to evaluate the hazards of discontinuing daily oral penicillin at the age of five years. Within three months of their fifth birthdays, all children were randomized to continue oral penicillin prophylaxis or to stop prophylaxis. Each child was followed for a minimum of two years. The primary endpoint was a comparison of documented pneumococcal infection in children continuing penicillin after five years of age versus children whose prophylaxis was stopped at five years of age. Ancillary studies conducted in subsets of patients included: the prevalence of colonization of the nasopharynx with antibiotic resistant microorangisms; and the relationship of antibody response to pneumococcal vaccination to the incidence of pneumococcal sepsis in this patient population.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 5 Years
linkedct:eligibility_minimum_age N/A
linkedct:end_date October 1994
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000585
rdfs:label Trial NCT00000585
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000585
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 305
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/12010>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/14620>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/16270>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/19505>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/19799>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/20839>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/22258>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/31651>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/3183>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/43395>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/48924>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/53378>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/53665>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/58234>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/61804>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/7209>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/8646>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/968>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000585>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/38202>
linkedct:reference <http://static.linkedct.org/resource/reference/40330>
linkedct:reference <http://static.linkedct.org/resource/reference/44749>
linkedct:reference <http://static.linkedct.org/resource/reference/51326>
linkedct:reference <http://static.linkedct.org/resource/reference/52753>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date August 1983
linkedct:study_design Prevention, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date October 1994