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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Bacterial

Intervention: tigecycline (Drug); tigecycline (Drug); imipenem/cilastatin (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Clinical Response in Clinically Evaluable (CE) Population at Test-of-Cure (TOC) Visit

Secondary outcome:

Percentage of Participants With Clinical Response in Clinical Modified Intent-to-treat (c-mITT) Population at Test-of-Cure (TOC) Visit

Percentage of Participants With Clinical Response in Ventilator Associated Pneumonia (VAP) and Non-VAP Participants at Test-of-Cure (TOC) Visit

Percentage of Participants With Microbiological Response at the Pathogen Level Population at Test-of-Cure (TOC) Visit

Percentage of Participants With Microbiological Response at the Participant Level Population at Test-of-Cure (TOC) Visit

Detailed description: The sponsor internal decision has been taken to close the study on 15 of July 2011, due to difficulties in enrollment. This decision was not based on any safety issues.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

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

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: December 2008
Last updated: June 5, 2012

Page last updated: August 23, 2015

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