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Penicillin Prophylaxis in Sickle Cell Disease (PROPS) Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Penicillin Prophylaxis in Sickle Cell Disease (PROPS) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Penicillin Prophylaxis in Sickle Cell Disease (PROPS) Clinical research trials and Penicillin Prophylaxis in Sickle Cell Disease (PROPS) healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Penicillin Prophylaxis in Sickle Cell Disease (PROPS). Penicillin Prophylaxis in Sickle Cell Disease (PROPS) Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Penicillin Prophylaxis in Sickle Cell Disease (PROPS) clinical trial. Participants typically obtain the most effective healthcare available for their Penicillin Prophylaxis in Sickle Cell Disease (PROPS) condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Penicillin Prophylaxis in Sickle Cell Disease (PROPS)  Penicillin Prophylaxis in Sickle Cell Disease (PROPS)
Penicillin Prophylaxis in Sickle Cell Disease (PROPS)
For Condition: Anemia, Sickle Cell,Hematologic Diseases,Hemoglobinopathies,Infection (S. pneumoniae),Pneumonia
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: /5 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidBecton, , University of Arkansas
Additional Information:
Study ID Numbers: 305;
Study Start Date: August 1983
Record last reviewed: October 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000585
Other Hemoglobinopathies Studies:
1. Intravenous azithromycin plus intravenous ceftriaxone followed by oral azithromycin with intravenous levofloxacin followed by oral levofloxacin for the treatment of moderate to severely ill hospitalized patients with community acquired pneumonia.
2. Pediatric Community-Acquired Pneumonia
3. Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia
4. Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
5. Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia
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Penicillin Prophylaxis in Sickle Cell Disease (PROPS)
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