Community-Acquired Infections
Conditions
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).
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.
Interventions
DRUGtigecycline
Dosage form: Tigecycline 50 mg for injection (Lyophilized powder in 5 mL vial) Dosage frequency: Tigecycline 100 mg loading followed by 50 mg every 12 hrs (bid) Duration of therapy: 7 to 14 days
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited in Japan from November 2007 to February 2008.
Pre-assignment details
Subjects were screened up to 24 hours.
Participants by arm
| Arm | Count |
|---|---|
| Tigecycline Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Tigecycline |
|---|---|
| Age Continuous | 62.78 years STANDARD_DEVIATION 18.27 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / — |
| serious Total, serious adverse events | 1 / — |
Outcome results
Primary
Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit.
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
Population: All patients who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tigecycline | Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. | Cure | 6 participants |
| Tigecycline | Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. | Failure | 2 participants |
| Tigecycline | Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. | Indeterminate | 1 participants |