Medical Services

Clinical Trials at Englewood Hospital: Critical Care

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EHMC IRB Study #: E-13-527

Principal Investigator: 
Dr. Carmine Gianatiempo
Tel: 201-568-5250
Email: carmine.gianatiempo@ehmc.com

Study Coordinator: 
Sajjad Naqvi
Tel: 201-894-3917
Email: sajjadnaqvi25@gmail.com

Sponsor:
Achaogen, Inc.

Study Title:
A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Colistin in Patients with Infection due to Carbapenem-Resistant Enterobacteriaceae (CRE)

Eligibility requirements:
Patients of age 18 and older with a blood stream infection or pneumonia suspected to be caused by the drug-resistant bacteria carbapenem-resistant enterobacteriaceae (CRE)

Study objectives:
To determine if an investigational antibiotic called plazomicin can increase survival in patients with a CRE infection as compared to currently used antibiotics.

Procedures:
Eligible patients will be randomized 1:1 to receive either plazomicin (study drug) or colistin (approved antibiotic). Subjects will also receive a second antibiotic (either tigecycline or meropenem) as determined by the physician.

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EHMC IRB Study #:E-13-491

Principal Investigator: 
Dr. Carmine Gianatiempo
Tel: 201-568-5250
Email: carmine.gianatiempo@ehmc.com

Study Coordinator: 
Sajjad Naqvi
Tel: 201-894-3917
Email: sajjadnaqvi25@gmail.com

Sponsor:
Bayer HealthCare Pharmaceuticals

Study Title:
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

Eligibility requirements:
Patients of age 18 and older who are intubated or mechanically ventilated and have a microbiologically-confirmed pneumonia caused by Gram-negative organisms

Study objectives:
To evaluate the efficacy (superiority) and safety of aerosolized BAY 41-6551 (Amikacin Solution for Inhalation and the Pulmonary Drug Delivery System), versus placebo

Procedures:
Eligible patients will be randomized to receive either: (1) a 10 calendar day (20 doses) course of aerosolized BAY 41-6551 400 mg (amikacin) every 12 hours or (2) placebo (normal saline) administered in the same manner and according to the same schedule.  The study drug or placebo will be given as adjunctive therapy.  All patients will receive standard antibiotics.

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EHMC IRB Study #: E-12-462

Principal Investigator: 
Dr. Carmine Gianatiempo
Tel: 201-568-5250
Email: carmine.gianatiempo@ehmc.com

Study Coordinator: 
Sajjad Naqvi
Tel: 201-894-3917
Email: sajjadnaqvi25@gmail.com

Sponsor:
Asahi Kasei Pharma America Corporation

Study Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects with Severe Sepsis and Coagulopathy.

Eligibility requirements:
Patients who are at least 18 years old and are critically ill in the ICU with severe sepsis, at least one organ dysfunction, and coagulopathy (inability to form clots).

Study objectives:
To determine if treating with ART-123, in addition to the standard treatments, can reduce mortality.

Procedures:
Eligible patients will be randomly assigned, in a 1:1 ratio, to receive ART-123 or a matching placebo for 6 consecutive days. Patients will then be followed, as inpatients or outpatients, through Day 28. After the Day 28 Visit, telephone calls will be made at 3 months, 6 months, and 12 months to determine survival status.

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*Each listing only contains a summary of the study information. Please contact the Principal Investigator or Study Coordinator for the full details on a particular study.