Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Thomas C Pitts, M.D.
CONTACT
Lead
Hudson Medical
Recorded Endpoints: * Mortality * Time in the ICU * Time on a ventilator Administrative: An Emergency FDA IND must be submitted (FDA form 3926) for each patient. Subsequent to approval the primary investigator will obtain an authorization letter from Alexion Pharmaceuticals. Implementation: Prior to dosing the patient must receive ceftriaxone IV and this must be continued during the entire duration of therapy (vaccination will be mentioned shortly and is the only exception to prophylactic antibiotic coverage). If there is a clinical reason why the patient cannot receive Ceftriaxone (allergy, supply, etc) then an alternative prophylactic antibiotic covering Neisseria meningitis must be given for the duration of therapy. The SeroB and Quadrivalent meningococcal vaccines can be given if the duration of antibiotic therapy becomes unsafe or unfeasible. In that case, antibiotic therapy should be withdrawn no sooner than 2 weeks after vaccination with both meningococcal vaccines (see ACIP guidelines in complement deficient patients). It is preferred that vaccination is avoided while the patient is acutely ill and that prophylactic antibiotics are used as meningococcal vaccination can upregulate the immune system possibly worsening the patient's condition. Standard dosing protocol - Eculizumab 900mg IV every 7 days. Eculizumab is given IV over 30 minutes without the need of a pump (although one can be used if available). Supplemental doses of eculizumab can be given if clinically warranted at the discretion of the investigator and clinical team. The team should perform Murray scores daily for the first 72 hours THEN every other day unless a change is deemed necessary by the attending physician. (table 2) Complement blood levels should be drawn every 72 hours. They may be drawn sooner if there is clinical inquiry which would affect clinical decision making and/or after a dose of Eculizumab is given. The duration of therapy is at the discretion of the clinical team and investigator. Follow up at day 7, 14, and 28 after discharge.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
