I sure wish you all would either decide whether or not to believe protocol announced in various places for all to see. I sure don't see anything about homogenicity, messiness, arms, legs or stratification. They even provide phone number if one is so inclined. Texas big D thanks for the info provided in that GREAT LONE STAR STATE publication!
Project Title: Phase III Randomized, Placebo Controlled Multicenter Trial to Assess the Safety and Efficacy of rBPI21, in the Adjunctive Treatment of Pediatric Patients with Severe Meningococcal Disease
Principal Investigator: John Bradley, M.D.
IRB Reference Number: #0655
Description: A randomized study for children with menningococcemia. Children receive placebo or rBPI21, in addition to their normal treatment
Eligibility Criteria:
Gender: Both
Age: Three months old to eighteen years old
Disease Name: Menningococcemia
Other Criteria: Patients must have presumptive diagnosis of meningococcemia; Glascow menningococcal Septicemia Prognostic Score >8; must receive BPI21 within eight hours of the first dose of antibiotic
Exclusion Criteria: None listed
Location: Children's Hospital-San Diego, 3020 Children's Way, San Diego, CA 92123
Requires Inpatient Stay: Yes
Facility where the study is being done: Children's Hospital-San Diego, 3020 Children's Way, San Diego, CA 92123
Compensation: None
Contact Name: Infectious Disease Research Office
Contact Phone: (619) 495-7785
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