This study will compare the safety and efficacy of a tigecycline regimen versus an
imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with
hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have
ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and
compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from
a minimum of 7 & up to 14 consecutive days, the exact duration will be at the decision of
the investigator based on the subject's condition. Additional protocol specified antibiotics
may be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit
will be done 10 to 21 days after the last day of therapy. The total duration of subject
participation will be between 17 and 44 days, including a follow up period of 30 days after
the last day of therapy for SAEs.
Subjects will be followed for safety and efficacy. The safety assessment will include:
physical examinations, vital signs, assessment of the clinical signs and symptoms of
pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology,
serum chemistries, and coagulation parameters, & a serum or urine pregnancy test before
study entry for women of childbearing potential. The clinical and microbiological efficacy
will both be evaluated.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Male or female subjects, greater than or equal to 18 years of age, known or suspected
to have acute hospital-acquired pneumonia (HAP).
- Acute HAP is defined as pneumonia with onset of symptoms:
1. Greater than or equal to 48 hours after admission to an acute care hospital or
chronic care facility such as a skilled nursing home facility or rehabilitation
unit. Or
2. Less than or equal to 7 days after the subject was discharged from the hospital.
The initial hospitalization must have been greater than or equal to 3 days
duration.
- VAP is defined as: onset of symptoms of pneumonia greater than or equal to 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, dyspnea or tachypnea, pleuritic
chest pain, rales and/or evidence of pulmonary consolidation, hypoxemia, or purulent
sputum production.
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, contraindication, or hypersensitivity to any of the test articles.
Pfizer Investigational Site, Provincia de Buenos Aires, Argentina
Pfizer Investigational Site, Victoria 3128, Australia
Pfizer Investigational Site, Santiago, Chile
Pfizer Investigational Site, Bogota, Colombia
Pfizer Investigational Site, Zagreb 10000, Croatia
Pfizer Investigational Site, Argenteuil 95100, France
Pfizer Investigational Site, Debrecen 4043, Hungary
Pfizer Investigational Site, Nyiregyhaza 4400, Hungary
Pfizer Investigational Site, Szekesfehervar 8000, Hungary
Pfizer Investigational Site, Vac 2600, Hungary
Pfizer Investigational Site, Daugavpils LV-5417, Latvia
Pfizer Investigational Site, Riga 1001, Latvia
Pfizer Investigational Site, Riga LV-1001, Latvia
Pfizer Investigational Site, Moscow 119620, Russian Federation
Pfizer Investigational Site, Moscow 121359, Russian Federation
Pfizer Investigational Site, Novosibirsk 630051, Russian Federation
Pfizer Investigational Site, St Petersburg 194354, Russian Federation
Pfizer Investigational Site, St Petersburg 196247, Russian Federation
Pfizer Investigational Site, Vsevolozhsk 188640, Russian Federation
Pfizer Investigational Site, Tainan 407, Taiwan
Pfizer Investigational Site, Tainan, Taiwan
Pfizer Investigational Site, Taipei TOC 100, Taiwan
Pfizer Investigational Site, Taipei 100, Taiwan
Pfizer Investigational Site, Medellin, Antioquia, Colombia
Pfizer Investigational Site, La Plata, Buenos Aires 1900, Argentina
Pfizer Investigational Site, Louisville, Kentucky, United States
Pfizer Investigational Site, Seoul, Korea 152-703, Korea, Republic of
Pfizer Investigational Site, Seoul, Korea 136-705, Korea, Republic of
Pfizer Investigational Site, Seoul, Korea 138-736, Korea, Republic of
Pfizer Investigational Site, Seoul, Korea 135 710, Korea, Republic of
Pfizer Investigational Site, Belo Horizonte, MG 30150-221, Brazil
Pfizer Investigational Site, Godoy Cruz, Mendoza, Argentina
Pfizer Investigational Site, Omaha, Nebraska 68131, United States
Pfizer Investigational Site, La Plata, Provincia de Buenos Aires B1900AVG, Argentina
Pfizer Investigational Site, Chicoutimi, Quebec G7H 5H6, Canada
Pfizer Investigational Site, Trois-Rivieres, Quebec G8Z 3R9, Canada
Pfizer Investigational Site, Nambour, Queensland 4560, Australia
Pfizer Investigational Site, Porto Alegre, RS 90610-000, Brazil
Pfizer Investigational Site, Sao Jose do Rio Preto, SP 15090-000, Brazil
Pfizer Investigational Site, Morgantown, West Virginia 26506, United States