Sponsored Clinical Trials

 

The Department of Anesthesiology Research through it's comment to conduct clinical research and through its long-standing collaborative relationships with other departments and schools within the university has been awarded a number of industry sponsored clinical trials. Our current clinical trials, in which we are actively recruiting, and are described below:

 

Nosocomial Pneumonia Two Trials (gram-positive and gram-negative)

 

Title: A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia

 

This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3 study of TR-701 FA 200 mg IV once daily for 7 days versus linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the treatment of ventilated patients with presumed gram-positive HABP or VABP. Patients with concurrent gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm.

 

Approximately 300 sites will participate. Ventilated patients with HABP/VABP caused by presumed gram-positive pathogen(s) at baseline, as determined by positive Gram stain, will be randomized 1:1 to study drug treatment.

 

Experimental Arm: TR-701 FA IV 200 mg once daily for 7 days, or 14 days for bacteremia

Active Comparator: Linezolid IV

Linezolid IV 600 mg twice daily for 10 days or 14 days for bacteremia

 

Key Inclusion Criteria :

18 Years and older

Patients requiring IV antibiotic therapy with diagnosis of ventilated nosocomial

pneumonia

Gram-positive bacteria on respiratory Gram stain

Sponsor: Cubist Pharmaceuticals NCT02019420

Effective January 22, 2015, Cubist Pharmaceuticals is now a wholly owned subsidiary of Merck & Co., Inc.

Principal Investigator: Bent, Sabrina, M.D., M.S.

Co-Principal Investigator: Ninan, Neal M.D. Pulmonary Diseases, Critical Care &

Environmental Medicine

 

 

Title: A Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam Compared With Meropenem in Adult Patients with Ventilated Nosocomial Pneumonia (VNP)

 

Experimental Arm: Ceftolozane/tazobactam

ceftolozane/tazobactam IV 3000 mg (comprising 2000 mg ceftolozane and 1000 mg

tazobactam) every 8 hours for 8 days, or 14 days for Pseudomonas aeruginosa.

Active Comparator: meropenem

meropenem IV 1000 mg every 8 hours for 8 days, or 14 for Pseudomonas aeruginosa

 

Key Inclusion Criteria :

1. Adult patients diagnosed with either VABP or ventilated HABP requiring IV

antibiotic therapy

2. Hospitalized for ≥ 48 hours, intubated and on mechanical ventilation at the time of

randomization;

3. APACHE II score between 15 and 35;

4. New or progressive infiltrate on chest radiography consistent with pneumonia

5. Presence of clinical criteria consistent with a diagnosis of ventilated nosocomial

pneumonia

Sponsor: Cubist Pharmaceuticals NCT02070757

Effective January 22, 2015, Cubist Pharmaceuticals is now a wholly owned subsidiary of Merck & Co., Inc.

Principal Investigator: Bent, Sabrina, M.D., M.S. Anesthesiology

Co-Principal Investigator: Ninan, Neal M.D. Pulmonary Diseases, Critical Care &

Environmental Medicine

 

Cardiac Surgery; Cardiopulmonary Bypass

Title: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiac Surgery with Cardiopulmonary Bypass

 

The purpose of this study is to determine the safety and effectiveness of human-derived antithrombin III (AT-III [Human]) supplementation prior to high-risk, non-emergency, cardiac surgery with cardiopulmonary bypass (CPB). A total of 404 adult subjects undergoing CPB who meet the study eligibility criteria will be randomized to receive either AT-III (Human) or placebo.

 

Experimental Arm: AT-III (Human)

Single intravenous dose of AT-III (Human) sufficient to achieve an absolute increase of 20% (percentage points) above pretreatment AT levels according the following formula:

AT-III (Human) dose (IU) required = (20) × (subject weight in kg) / 1.4

Placebo Comparator: Placebo 0.9% Sodium Chloride for Injection,

Single intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose.

 

Key Inclusion Criteria :

1. Subject needs non-emergency cardiac surgery with cardiopulmonary bypass.

Types of cardiac operations permitted:

-- complex/combined procedures (coronary artery bypass graft [CABG] plus valve)

-- double/triple valve repair/replacements,

-- ascending aorta/aortic arch surgeries (without baseline AT level restriction or preoperative

heparin requirement). OR

-- Isolated CABG or single valve repair/replacements are allowed only if either (a) AT level is

less than 80% OR (b) preoperative heparin is received (unfractionated heparin [UFH] for at

least 12 hours; low- molecular-weight heparin [LMWH] for more than 5 days).

 

Sponsor: Grifols Therapeutic NCT02037555

Principal Investigator: Bent, Sabrina, M.D., M.S. Anesthesiology

Co-Principal Investigator: Weaver, Michael M.D. Cardiovascular (Thoracic Surgery)

 

 

Participation

If you or a loved one is interested in participating in a one of these clinical trials please call the Department of Anesthesiology Research Office at 504-988-0967 or contact Marcia Henry, Ph.D. Senior Research Coordinator by email; mhenry3@tulane.edu.

 

 

© 2016 Tulane Department of Anesthesiology

Department of Anesthesiology, 1415 Tulane Avenue, New Orleans, LA 70112-2699 | 504-988-5903 | info@tulaneanesthesiology.com

Web Development by: Christian Watson