Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
Study Details
Study Description
Brief Summary
To purpose of this study is to assess the safety and tolerability of intravenous (IV) tigecycline in hospitalized subjects of Japanese descent with community-acquired pneumonia (CAP).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This is a multicenter, open-label study evaluating the safety and efficacy of tigecycline in the treatment of Japanese subjects with CAP. Subjects with clinical signs and symptoms of CAP who meet the eligibility requirements will be considered for enrollment. Qualifying subjects will be assigned to receive tigecycline via IV administration for 7 to 14 consecutive days. The exact duration of administration of the study drug will be at the discretion of the investigator, based on the subject's condition. Subjects will be followed for safety until the test-of-cure (TOC) assessment 10 to 21 days after the last dose of therapy, and for efficacy until TOC assessment.
Study Design
Outcome Measures
Primary Outcome Measures
- Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. [8 weeks]
Clinical response: Cure=all initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR)improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for nonstudy drug/infection reasons (eg, lost to follow-up); death ≤2 days after first dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Hospitalized Japanese descent subjects known or suspected to have CAP with a severity that requires IV antibiotic treatment.
-
Chest radiograph within 48 hours before the first dose of IV test article showing the presence of a new infiltrate.
-
The presence of fever or hypothermia within 24 hours before the first administration of test article, and of at least two signs/symptoms of CAP within 24 hours before the first administration of test article.
Exclusion Criteria:
-
Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed.
-
Hospital-acquired pneumonia, other lung disease including viral, fungal, or parasitic pneumonia, immunosuppressive conditions, and other illness, which affect evaluation of safety and efficacy of tigecycline.
-
Known or suspected hypersensitivity to tigecycline or tetracyclines, or contraindication for these antibiotics.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Toyota-shi | Aichi | Japan | 471-8513 | |
| 2 | Kurume-shi | Fukuoka | Japan | 830-8543 | |
| 3 | Yanagawa-shi | Fukuoka | Japan | 832-0059 | |
| 4 | Asahikawa-shi | Hokkaido | Japan | 070-8644 | |
| 5 | Tokai-mura | Ibaraki | Japan | 319-1113 | |
| 6 | Yokohama-shi | Kanagawa | Japan | 230-0012 | |
| 7 | Yokohama-shi | Kanagawa | Japan | 236-0051 | |
| 8 | Suwa-shi | Nagano | Japan | 392-8510 | |
| 9 | Kiyose-shi | Tokyo | Japan | 204-8585 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3074A1-3331
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited in Japan from November 2007 to February 2008. |
|---|---|
| Pre-assignment Detail | Subjects were screened up to 24 hours. |
| Arm/Group Title | Tigecycline |
|---|---|
| Arm/Group Description | Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator. |
| Period Title: Overall Study | |
| STARTED | 9 |
| COMPLETED | 6 |
| NOT COMPLETED | 3 |
Baseline Characteristics
| Arm/Group Title | Tigecycline |
|---|---|
| Arm/Group Description | Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator. |
| Overall Participants | 9 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
62.78
(18.27)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
3
33.3%
|
| Male |
6
66.7%
|
Outcome Measures
| Title | Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. |
|---|---|
| Description | Clinical response: Cure=all initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR)improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for nonstudy drug/infection reasons (eg, lost to follow-up); death ≤2 days after first dose for any reason, or >2 days but before TOC visit for non-pneumonia reason. |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who received at least one dose of study drug. |
| Arm/Group Title | Tigecycline |
|---|---|
| Arm/Group Description | Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator. |
| Measure Participants | 9 |
| Cure |
6
66.7%
|
| Failure |
2
22.2%
|
| Indeterminate |
1
11.1%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Tigecycline | |
| Arm/Group Description | Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator. | |
All Cause Mortality |
||
| Tigecycline | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Tigecycline | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/ (NaN) | |
| Hepatobiliary disorders | ||
| Liver Dysfunction | 1/9 (11.1%) | |
Other (Not Including Serious) Adverse Events |
||
| Tigecycline | ||
| Affected / at Risk (%) | # Events | |
| Total | 9/ (NaN) | |
| Gastrointestinal disorders | ||
| Diarrhea | 4/9 (44.4%) | |
| Nausea | 9/9 (100%) | |
| Stomach Disorder | 1/9 (11.1%) | |
| Vomiting | 4/9 (44.4%) | |
| Investigations | ||
| Alanine aminotransferase increased | 1/9 (11.1%) | |
| Aspartate aminotransferase increased | 1/9 (11.1%) | |
| Bilirubin conjugated increased | 1/9 (11.1%) | |
| Blood bilirubin increased | 1/9 (11.1%) | |
| Blood urea increased | 1/9 (11.1%) | |
| Metabolism and nutrition disorders | ||
| Anorexia | 1/9 (11.1%) | |
| Musculoskeletal and connective tissue disorders | ||
| Muscular weakness | 1/9 (11.1%) | |
| Nervous system disorders | ||
| Headache | 1/9 (11.1%) | |
| Psychiatric disorders | ||
| Insomnia | 1/9 (11.1%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
| Name/Title | U. S. Contact Center |
|---|---|
| Organization | Wyeth |
| Phone | |
| clintrialresults@wyeth.com |
- 3074A1-3331