Trial Outcomes & Findings for Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects (NCT NCT00575094)

Last Updated: 2011-06-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

9 participants

Primary outcome timeframe

8 weeks

Results posted on

2011-06-03

Participant Flow

Subjects were recruited in Japan from November 2007 to February 2008.

Subjects were screened up to 24 hours.

Participant milestones

Participant milestones
Measure	Tigecycline Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
Overall Study STARTED	9
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Tigecycline Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tigecycline n=9 Participants Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
Age Continuous	62.78 years STANDARD_DEVIATION 18.27 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: All patients who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Tigecycline n=9 Participants Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. Cure	6 participants
Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. Failure	2 participants
Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. Indeterminate	1 participants

Adverse Events

Tigecycline

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tigecycline Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
Hepatobiliary disorders Liver Dysfunction	11.1% 1/9

Other adverse events

Other adverse events
Measure	Tigecycline Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
Gastrointestinal disorders Diarrhea	44.4% 4/9
Gastrointestinal disorders Nausea	100.0% 9/9
Gastrointestinal disorders Stomach Disorder	11.1% 1/9
Gastrointestinal disorders Vomiting	44.4% 4/9
Investigations Alanine aminotransferase increased	11.1% 1/9
Investigations Aspartate aminotransferase increased	11.1% 1/9
Investigations Bilirubin conjugated increased	11.1% 1/9
Investigations Blood bilirubin increased	11.1% 1/9
Investigations Blood urea increased	11.1% 1/9
Metabolism and nutrition disorders Anorexia	11.1% 1/9
Musculoskeletal and connective tissue disorders Muscular weakness	11.1% 1/9
Nervous system disorders Headache	11.1% 1/9
Psychiatric disorders Insomnia	11.1% 1/9

Additional Information

U. S. Contact Center

Wyeth

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER