Infectious Disease Research Staff & Critical Care/Pulmonologists Research Staff

Experienced and committed in performing pharmaceutical and biotech clinical research studies of many disease conditions with strict adherence to institution and government regulations.

Research includes:

• Development of medications such as antibiotics, antifungals/anti moulds, vaccines and monoclonal antibodies
• Treatment of sepsis /septic shock
• Medicated coated device/device studies  

There are 10 board-certified physicians in the Infectious Disease Section involved in clinical research which include: 

• John  Reinhardt, M.D.
• Alfred Bacon, M.D.
• David Cohen, M.D.
• John Piper, M.D.
• Anand Panwalker, M.D.
• Stephanie Lee, M.D.
• James Ley, M.D.
• Wesley Emmons, M.D.
• Kirsten Hauer, M.D.

There are seven board-certified Critical Care Intensivists/Pulmonologists involved in clinical research which include:

• Michael DePietro, M.D.
• Gerald M O'Brien, M.D.
• Donald Collins, M.D.
• Marc Zubrow, M.D.
• Farid M. Moosavy, M.D.
• Vinay Maheshwari, M.D.                                                   
• Tuhina Raman, M.D.              

Administrative support is provided by Lee Rubin, Clinical Research Manager, Christiana Care Research Institute. 

Dedicated Research Coordinators include: 

• Patty McGraw RN, MS, CCRC 
• Robie Zent RN
• Barbara Tambourelli, RN

For More Information: 
Christiana Care Health System
Christiana Hospital, RM 1140
4755 Ogletown Stanton Road
Newark, Delaware 19718
Phone: 302 -733- 4163
Fax:     302- 733- 4170

Christiana Care's participation in these trials is approved by the Christiana Care Institutional Review Board (IRB). The IRB is a committee that reviews research projects to help ensure that the rights of the research subjects are protected.

New Studies Open

Study Title	A Phase 2, Multicenter, Randomized, Double-Blind, Comparative Study of  the Safety and Efficacy of 2 Doses of Tigecycline vs Imipenem/Cilastatin for the Treatment of Subjects with Hospital-Acquired Pneumonia (HAP) 28189
Purpose	The main purpose of this study is to compare the safety and effectiveness of 2 dose levels of tigecycline with another antibiotic called imipenem/cilastatin for treating HAP [includes patients on ventilators (breathing machine)]. Both antibiotics are given IV (intravenously) in the arm.
Qualifications	Male or female subjects = 18 years of age Confirmed/Suspected HAP  Symptom onset occurring:  =  48 hours after admission to the hospital, nursing home, or rehabilitation unit, or  =  7 days after the subject was discharged from hospital  (hospitalization must have been = 3 days), or  = 48 hours after endotracheal intubation (breathing tube placed) Presence of a new or evolving infiltrate on a chest X-ray film.
Benefits	No additional costs for study related procedures  which include: Treatment provided by an Infectious Disease Specialist, Study drug Lab tests, chest X-rays, follow-up visit (travel reimbursement)
Contact Info	Infectious Disease Research Nurses 302-733-4163

Study Title	A Prospective, Multicenter, Investigator-blinded, Randomized, Comparative Study to Estimate the Safety, Tolerability, and Efficacy of  NXL104/Ceftazidime vs. Imipenem Cilastatin Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections (cUTI) in Hospitalized Adults 28159
Purpose	The main purpose of this study is to further evaluate the safety and effectiveness of the study drug, NXL104, given with  ceftazidime (FDA approved antibiotic) in patients with a cUTI.   NXL104 is being compared to Imipenem Cilastatin (FDA approved antibiotic). NXL104 is an investigational drug that is intended to stop the effect of some specific enzymes that bacteria produce that can make antibiotics less effective.
Qualifications	Male or female subjects = 18 & = 90 years of age, no pregnancy, Admission to hospital Confirmed/suspected cUTI (includes pyelonephritis) The criteria used to determine that you have a cUTI include:        (1) urinalysis indicating an infection       (2) your overall medical condition       (3) specific clinical signs of cUTI
Benefits	No additional costs for study related procedures  which include: Treatment provided by an Infectious Disease Specialist, Study Medication (IV and oral) Lab tests, chest x rays, follow-up visits (travel reimbursement)
Contact Info	Infectious Disease Research Nurses 302-733-4163

Study Title	A Prospective, Randomized, Double Blind, Double Dummy, Multicenter Study to Assess the Safety and Efficacy of Doripenem Compared with Imipenem in the Treatment of Subjects with Ventilator Associated Pneumonia.(VAP) 28168
Purpose	The main purpose of this study is to compare the safety and efficacy (how well it works) of doripenem compared to imipenem (an FDA approved antibiotic often used to treat many types of infections including VAP) in patients with VAP.  Both antibiotics are given by IV (intravenously).
Qualifications	Male or female (non-pregnant) subjects = 18 years of age. = 48 hours on mechanical ventilation (breathing machine) Presence of a new or evolving infiltrate on a chest X-ray film.
Benefits	No additional costs for study related procedures  which include: Treatment provided by a Pulmonologist  (Lung Specialist)  Study Medication Lab tests, chest x rays, bronchoscopy, travel reimbursement (follow-up visits)
Contact Info	Infectious Disease Research Nurses 302-733-4163

Study Title	A double-blind, randomized, stratified, multi-center trial evaluating conventional and high dose oseltamivir in the treatment of immunocompromised patients with influenza  27168
Purpose	The main purpose of this study is to determine the safety and effectiveness of oseltamivir (Tamiflu) in immunocompromized patients suspected of being infected with the influenza (flu) virus.  Immunocompromized patients include those that have had a  liver or kidney, or liver and kidney transplant or a stem cell transplant.  These patients are taking medications that weaken their immune system making viral infections, including influenza, much worse.   Oseltamivir is FDA approved for the use in those that have a normal immune system.  The use of oseltamivir in this study is investigational.
Qualifications	> 18 years Cannot be pregnant   Organ (liver, kidney, or liver and kidney) transplant > 6 months ago or a Stem cell (bone marrow) transplant that is working properly   Experiencing  symptoms of an influenza-like illness such as: fever, body aches, dry cough, headache, tiredness, sore throat and others
Benefits	Infectious Disease Physician management Laboratory Tests, Immediate flu test result Physical examination Study related medication  (oseltamivir 75mg or 150mg for 10 days) May get better quicker   Travel reimbursement
Contact Info	Infectious Disease Research Nurses 302-733-4163