Bacterial Infections
Conditions
Keywords
Bacterial Infections
Brief summary
The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations. The secondary objective is to evaluate the safety and efficacy of tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful.
Interventions
DRUGTigecycline
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
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms. * Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies. * Patient must give informed consent.
Exclusion criteria
* Patients with an expected survival of less than 2 weeks. * Patients who have been designated as Do Not Resuscitate. * Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents. * Pregnant women or nursing mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response | — |
Secondary
| Measure | Time frame |
|---|---|
| micro response at subject level | — |
| micro response at pathogen level | — |
| clinical response at pathogen level | — |
| development of decreased susceptibility | — |
Countries
Germany, Poland
Outcome results
None listed