DFA-02 in Patients Undergoing Colorectal Surgery
This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and pharmacokinetics of DFA-02.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo Controlled, Safety, Tolerability, and Pharmacokinetic Dose Escalation Study of DFA-02 in Patients Undergoing Colorectal Surgery|
- Number of Patients With Adverse Events, Laboratory, Physical Examination Changes [ Time Frame: Baseline up to Day 30 ] [ Designated as safety issue: Yes ]Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.
- Area Under Curve (AUC) [ Time Frame: 1, 6, 24, 48 96 hours post-dose ] [ Designated as safety issue: Yes ]Area under the curve (AUC) of plasma gentamicin and vancomycin levels using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery
- Maximal Plasma Concentration (Cmax) [ Time Frame: 1, 6, 24, 48, 96 hours post-dose ] [ Designated as safety issue: Yes ]Maximal plasma concentration (Cmax)of gentamicin and vancomycin using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery
- Renal Function [ Time Frame: Baseline up to Day 14 ] [ Designated as safety issue: Yes ]Changes in serum creatinine from surgery on Day 1 until 14 days after surgery
- Antibiotic Resistance [ Time Frame: Baseline up to Day 5 ] [ Designated as safety issue: Yes ]Methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus presence at surgery on Day 1 and 5 days after surgery
- Incidence of Surgical Site Infection [ Time Frame: Up to 30 Days After Surgery ] [ Designated as safety issue: No ]The incidence of probable or definite surgical site infection as determined by the Investigator.
|Study Start Date:||February 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Progressive cohorts of 10 subjects (8 active, 2 placebo) receiving 10, 20 , 30 or 40 mL of DFA-02 or matching placebo.
Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure
|Placebo Comparator: DFA-02 placebo||
Despite antibiotic prophylaxis and improvements in surgical techniques, surgical site infections (SSI) still occur. DFA-02 is a novel bioresorbable modified release gel containing both gentamicin and vancomycin to be applied during surgical incision closure for the prevention of surgical site infections (SSIs) in patients undergoing colorectal surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496352
|United States, Alabama|
|Florence, Alabama, United States|
|United States, Florida|
|Tampa, Florida, United States|
|United States, Ohio|
|Columbus, Ohio, United States|
|United States, Texas|
|Bellaire, Texas, United States|
|Temple, Texas, United States|
|Study Director:||Kent Allenby, MD||Dr. Reddy's Laboratories|