A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF TIGECYCLINE VERSUS IMIPENEM/CILASTATIN FOR THE TREATMENT OF SUBJECTS WITH HOSPITAL-ACQUIRED PNEUMONIA
- Conditions
- Hospital-Acquired Pneumonia (HAP) including Ventilator-Associated Pneumonia (VAP)MedDRA version: 9.1Level: PTClassification code 10035664Term: Pneumonia
- Registration Number
- EUCTR2008-000412-33-LV
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
Male or female subjects =18 years of age known or suspected to have acute HAP.
- Acute HAP is defined as pneumonia with onset of symptoms:
a. = 48 hours after admission to an acute care hospital or chronic care facility such as a skilled nursing home facility or rehabilitation unit.
b. = 7 days after the subject was discharged from the hospital. The initial hospitalization must have been =3 days duration.
- VAP is defined as: onset of symptoms of pneumonia = 48 hours after endotracheal intubation.
Presence of a new or evolving infiltrate on a chest x-ray film, presence of fever or leukocytosis, respiratory failure requiring mechanical ventilation or presence of 2 of the following clinical signs and symptoms: cough or dyspnea, tachypnea or pleuritic chest pain, rales and/or evidence of pulmonary consolidation, hypoxemia, or purulent sputum production.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects with other significant underlying conditions that would make it difficult to evaluate the subjects or make it unlikely to complete the therapy or that would increase their risk by participating in the study, infection with organisms known to be resistant, contraindications, or hypersensitivity to any of the test articles, known Legionella infection, known Pseudomonas aeruginosa infection, hemodialysis, hemofiltration, peritoneal dialysis, plasmapheresis, presence of sustained shock, Acute Physiologic and Chronic Health Evaluation Scale (APACHE) II score > 30, significant neutropenia, hepatic and/or renal insufficiency, antibacterial drugs administered for > 24 hours before study entry unless resistance demonstrated or no improvement, known human immunodeficiency virus (HIV) infection, pregnant women or nursing mothers.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method