Phase 3
Completed N=9
Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
Community-Acquired Infections
Source: ClinicalTrials.gov NCT00575094 ↗
Enrolled (actual)
9
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. — 6; 2; 1 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. |
6; 2; 1 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00575094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.