Bacterial PneumoniaPhase 3NCT00080496
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
A Phase 3 study testing Tigecycline, Imipenem and Cilastatin in people with Bacterial Pneumonia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 29 sites in United States.
Trial summary
To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bacterial Pneumonia
- What is being tested?
- Tigecycline, Imipenem and Cilastatin
- How many people
- 430 participants
- Where
- 29 sitesUnited States
- Study dates
- Jul 2003to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects over 18 years of age. Bulgaria Only: Male or female subjects over 18 years of age and under 70 years of age.
- Subjects known or suspected to have acute hospital-acquired pneumonia.
Who cannot join
- Presence of any of the following pulmonary conditions: cystic fibrosis; pulmonary malignancy (either primary or metastatic); known bronchial-obstructive or post obstructive pneumonia; pulmonary abscess; empyema; known or suspected active tuberculosis; bronchiectasis; sarcoidosis; known or suspected pulmonary infection caused by Pneumocystis carinii, mycobacteria, fungi, parasites, or viruses (Subjects with COPD are not excluded)
- Suspected or known Legionella infection
- Concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Study site
Atlanta, Georgia, 30342
Study site
Augusta, Georgia, 30909
Study site
Baltimore, Maryland, 21201
Study site
Bay Pines, Florida, 33744
Study site
Chicago, Illinois, 60610
Study site
Cincinnati, Ohio, 45219
Study site
Columbia, Missouri, 65212
Study site
Crystal River, Florida, 34428
Study site
Gainesville, Florida, 32601
Study site
Greenville, South Carolina, 29605
Study site
Henderson, North Carolina, 27536
Study site
Martinez, California, 94553
Study site
Modesto, California, 95350
Study site
Modesto, California, 95355
Study site
National City, California, 91950
Study site
New Orleans, Louisiana, 70112
Study site
Omaha, Nebraska, 68198-5300
Study site
Orlando, Florida, 32806
Study site
Philadelphia, Pennsylvania, 19102
Study site
Philadelphia, Pennsylvania, 19140
Study site
Phoenix, Arizona, 85006
Study site
Phoenix, Arizona, 85013
Study site
Roswell, Georgia, 30076
Study site
Scottsdale, Arizona, 85251-6403
Study site
Scottsdale, Arizona, 85260-6709
Study site
Shreveport, Louisiana, 71103
Study site
Springfield, Illinois, 62769
Study site
Springfield, Illinois, 62781
Study site
Zanesville, Ohio, 43071
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Imipenem/Cilastatin For The Treatment Of Subjects With Nosocomial Pneumonia
To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.
- Conditions
- Bacterial Pneumonia
- Being tested
- Tigecycline, Imipenem, Cilastatin
- Keywords
- Pneumonia
- Medical subject headings
- Pneumonia, Bacterial, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TigecyclineDrug
ImipenemDrug
CilastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The co-primary efficacy endpoints are clinical response at the TOC assessment for the clinically evaluable population and the clinical modified intent-to-treat population.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2004 (estimated)
- Study startJul 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 430 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080496
- Sponsor's protocol ID
- 3074A1-311
- Status last verified
- Jul 2008
- First submitted
- 5 Apr 2004
- Last updated
- 4 Aug 2008
- Results posted
- No
Publications
Karageorgopoulos DE, Kelesidis T, Kelesidis I, Falagas ME. Tigecycline for the treatment of multidrug-resistant (including carbapenem-resistant) Acinetobacter infections: a review of the scientific evidence. J Antimicrob Chemother. 2008 Jul;62(1):45-55. doi: 10.1093/jac/dkn165. Epub 2008 Apr 24.
PubMed 18436554
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Imipenem/Cilastatin For The Treatment Of Subjects With Nosocomial Pneumonia
- ClinicalTrials.gov ID
- NCT00080496
- Acronym / sponsor ID
- 3074A1-311
- Conditions
- Bacterial Pneumonia
- Keywords
- Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 7 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects over 18 years of age. Bulgaria Only: Male or female subjects over 18 years of age and under 70 years of age.
- Subjects known or suspected to have acute hospital-acquired pneumonia.
Key exclusion criteria (3 listed)
- Presence of any of the following pulmonary conditions: cystic fibrosis; pulmonary malignancy (either primary or metastatic); known bronchial-obstructive or post obstructive pneumonia; pulmonary abscess; empyema; known or suspected active tuberculosis; bronchiectasis; sarcoidosis; known or suspected pulmonary infection caused by Pneumocystis carinii, mycobacteria, fungi, parasites, or viruses (Subjects with COPD are not excluded)
- Suspected or known Legionella infection
- Concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tigecycline | Drug | – |
| Imipenem | Drug | – |
| Cilastatin | Drug | – |
Primary outcome
The co-primary efficacy endpoints are clinical response at the TOC assessment for the clinically evaluable population and the clinical modified intent-to-treat population.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2008.
- Derived from this study: PubMed 18436554Karageorgopoulos DE, Kelesidis T, Kelesidis I, Falagas ME. Tigecycline for the treatment of multidrug-resistant (including carbapenem-resistant) Acinetobacter infections: a review of the scientific evidence. J Antimicrob Chemother. 2008 Jul;62(1):45-55. doi: 10.1093/jac/dkn165. Epub 2008 Apr 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tigecycline, Imipenem and Cilastatin in people with Bacterial Pneumonia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The co-primary efficacy endpoints are clinical response at the TOC assessment for the clinically evaluable population and the clinical modified intent-to-treat population.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00080496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2008.