Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pneumonia, Bacterial

In brief

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.

Key facts

Study ID: NCT00707239
Run by: Pfizer
People needed: 108
Starts: 2008-12-01
Expected to finish: 2011-06-01
Last updated by the study team: 2012-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
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
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.

You may not qualify if…

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.

Where it is running

Pfizer Investigational Site — Louisville, Kentucky, United States
Pfizer Investigational Site — Omaha, Nebraska, United States
Pfizer Investigational Site — Morgantown, West Virginia, United States
Pfizer Investigational Site — La Plata, Buenos Aires, Argentina
Pfizer Investigational Site — La Plata, Buenos Aires, Argentina
Pfizer Investigational Site — Godoy Cruz, Mendoza Province, Argentina
Pfizer Investigational Site — Provincia de Buenos Aires, Argentina
Pfizer Investigational Site — Nambour, Queensland, Australia
Pfizer Investigational Site — Victoria, Victoria, Australia
Pfizer Investigational Site — Belo Horizonte, Minas Gerais, Brazil
Pfizer Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil
Pfizer Investigational Site — São José do Rio Preto, São Paulo, Brazil
Pfizer Investigational Site — Chicoutimi, Quebec, Canada
Pfizer Investigational Site — Trois-Rivières, Quebec, Canada
Pfizer Investigational Site — Santiago, Santiago Metropolitan, Chile
Pfizer Investigational Site — Medellín, Antioquia, Colombia
Pfizer Investigational Site — Bogotá, Colombia
Pfizer Investigational Site — Zagreb, Croatia
Pfizer Investigational Site — Argenteuil, France
Pfizer Investigational Site — Debrecen, Hungary
Pfizer Investigational Site — Nyíregyháza, Hungary
Pfizer Investigational Site — Székesfehérvár, Hungary
Pfizer Investigational Site — Vác, Hungary
Pfizer Investigational Site — Daugavpils, Latvia
Pfizer Investigational Site — Riga, Latvia

Full record on ClinicalTrials.gov

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