Trials / Completed
CompletedNCT00488345
Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age
A Multicenter, Open-Label, Ascending Multiple-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age With Selected Serious Infections
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 8 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections; complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), or community-acquired pneumonia (CAP).
Conditions
- Bacterial Infections
- Intra-Abdominal Infection
- Pneumonia, Bacterial
- Skin Diseases, Bacterial
- Skin Diseases, Infectious
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tygacil |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2009-09-01
- Completion
- 2009-09-01
- First posted
- 2007-06-20
- Last updated
- 2012-10-24
- Results posted
- 2012-10-24
Locations
36 sites across 6 countries: United States, Belgium, Mexico, South Africa, Taiwan, Ukraine
Source: ClinicalTrials.gov record NCT00488345. Inclusion in this directory is not an endorsement.