Hospital-Acquired Pneumonia (HAP) including Ventilator-Associated Pneumonia (VAP) MedDRA version: 9.1 Level: PT Classification code 10035664 Term: Pneumonia
Conditions
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the safety and efficacy of 2 higher tigecycline dose regimens with that of the imipenem/cilastatin regimen in order to determine the dose(s) of tigecycline that will be tolerable and non-inferior to imipenem/cilastatin in treating subjects with HAP.;Secondary Objective: Secondary objectives are: (1) to evaluate tigecycline efficacy in treating the VAP/non-VAP subject subpopulations; (2) to evaluate the microbiologic efficacy of tigecycline; (3) to obtain in vitro susceptibility data on tigecycline for a range of bacteria that cause HAP; (4) to obtain pharmacokinetic (PK)/pharmacodynamic (PD) information for these higher dose regimens of tigecycline in subjects with HAP; (5) to compare procalcitonin levels between treatment groups and explore the relationship between procalcitonin concentrations and response to treatment in subjects with HAP; (6) to compare health care resource utilization between treatment groups.;Primary end point(s): The primary efficacy endpoint is the clinical response in the clinically evaluable (CE) population at the Test-of-Cure (TOC) assessment, 10-21 days post therapy (primary time point) | — |
Countries
Estonia, France, Hungary, Latvia
Outcome results
None listed