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Label indication TYGACIL is a tetracycline class antibacterial indicated in patients 18 years of age and older for: • Complicated skin and skin structure infections ( 1.1 ) • Complicated intra-abdominal infections ( 1.2 ) • Community-acquired bacterial pneumonia ( 1.3 ) Limitations of Use : TYGACIL is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia (… FDA label
tigecycline · 12 trials · 15 indications
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.
Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, \>120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) \> 48 hrs.
Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, \>120% doses, non-routine surgical treatment or death related to DFI \> 48 hrs. Indeterminate: Lost to follow-up, death\<48 hours or noninfection related.
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | - |
| B | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | armDesc1 |
| Name | Type | Description |
|---|---|---|
| tigecycline | DRUG | 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 |
| Ertapenem | DRUG | Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage). |
| Levofloxacin | DRUG | - |
| Imipenem | DRUG | - |
| Cilastatin | DRUG | - |
| vancomycin with aztreonam | DRUG | - |
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 hypothe...
Tigecycline is a small molecule antibiotic developed by Pfizer, Inc. (NYSE: PFE). It has been studied in clinical trials for bacterial infections, including abdominal abscess, bacterial pneumonia, community-acquired pneumonia, community-acquired infections, and gram-negative bacterial infections. Its development program includes Phase 3 and Phase 1 studies, all of which have been completed.
Tigecycline has been studied for treating bacterial infections, including abdominal abscess, bacterial pneumonia, community-acquired pneumonia, community-acquired infections, and gram-negative bacterial infections. Clinical trials have also evaluated it in diabetic foot infections and complicated skin and skin structure infections. These studies were conducted in hospitalized and adult subjects across multiple countries.
Tigecycline is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the clinical trials evaluating the drug, including Phase 3 studies in diabetic foot infections and complicated skin and skin structure infections, as well as a Phase 1 pharmacokinetic study in subjects with primary biliary cirrhosis.
Tigecycline has been evaluated in Phase 3 and Phase 1 clinical trials, all of which are completed. The Phase 3 program includes studies in hospitalized Japanese subjects with community-acquired infections, diabetic foot infections with a substudy in osteomyelitis, and complicated skin and skin structure infections. No trials are currently active.
Tigecycline has been studied in completed trials including NCT00575094, a Phase 3 study in hospitalized Japanese subjects with community-acquired infections; NCT00406237, a Phase 1 pharmacokinetic study in adults with primary biliary cirrhosis; NCT00366249, a Phase 3 study in diabetic foot infections; and NCT00228410, a Phase 3 study in complicated skin and skin structure infections.