AeroVanc for the treatment of MRSA in people with CF
Study Type:
Interventional
Intervention Category:
Anti-Infective
Study Sponsor:
Savara
Study Phase:
2
Recruitment Status:
Recruiting
Study Drug(s):
Inhaled Vancomycin
Number of Participants Being Recruited:
80
Single / Multi-Center:
Multi-Center
STUDY BACKGROUND INFORMATION:
This is a Phase 2a randomized, multicenter, double-blind, placebo-controlled, parallel group study to examine the safety and effectiveness of AeroVanc in the treatment of persistent MRSA lung infection in people with CF 12 years and older. Participants will be randomized to receive Aerovanc two times a day or placebo. Specimens of blood, urine, and sputum will be taken throughout the study along with pulmonary lung function testing. The study may last up to 98 days for subjects not co-infected with P. aeruginosa and 127 days for those that are.
ELIGIBILITY
Age:
>= 12 Years
FEV1:
30 - 90 Percent Predicted
P. aeruginosa status:
Not applicable
B. cepacia status:
Negative
Other Primary Eligibility Requirements:
Eligible subjects must be chronically infected with MRSA
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
Contact Information:
Ksenich, Roberta (Bobbi) Phone: (216) 844-5733 Email: Roberta.Ksenich@UHHospitals.org
PA
Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
Contact Information:
Hartigan, Elizabeth Phone: (412) 692-7060 Email: elizabeth.hartigan@chp.edu
