ABOUT THIS STUDY
- Male or female patients aged 8 to 11 years, inclusive, willing and able to complete all activities required for the study
- Have a diagnosis of a serious infection (cIAI, cSSSI or CAP) requiring hospitalization and administration of IV antibiotic therapy during greater than or equal to 5 days
- Other inclusion criteria apply.
- Patients with any concomitant condition or taking any concomitant medication that, in
the opinion of the investigator, could preclude an evaluation of safety or efficacy
responses or make it unlikely that the anticipated course of therapy or follow-up
assessment will be completed (e.g., life expectancy < 30 days).
- Pregnant or breastfeeding female patients and female patients of childbearing
potential who are unable or unwilling to take adequate contraceptive precautions.
- Previous participation in this clinical trial.
- Receipt of any investigational drugs or devices (defined as lacking any regulatory
agency's approval within 4 weeks before administration of the first dose of
- Endocarditis; presence of an artificial heart valve or infected device that will not
- Known or suspected hypersensitivity to tigecycline or other compounds related to this
class of antibacterial agents (i.e., tetracyclines).
- Known or suspected P. aeruginosa infection.
- Patients receiving immunosuppressive therapy that, in the opinion of the investigator,
would decrease the patient's ability to eradicate the infection, including the use of
- Receipt of an organ or bone marrow transplant.
- Presence of any of the following laboratory findings: Neutropenia (absolute neutrophil
count < 1 × 109/L [< 1000/mm3]) , AST or ALT > 10 × the ULN or bilirubin > 3 × ULN,
unless isolated hyperbilirubinemia is directly related to the acute process (for
patients with cIAI).
- Patients with any of the following conditions:
- Cystic fibrosis.
- Active tuberculosis.
- Congenital immunodeficiency.
- Septic shock.
- Osteomyelitis (suspected or evident).
- Refractory shock syndrome in which hemodynamic parameters cannot be maintained
despite adequate supportive therapy.
- Confirmed malignancy with patient receiving an active course of chemotherapeutic
- Known or suspected infection with human immunodeficiency virus (HIV) or positive
test result for HIV antibody.
- Known or suspected concomitant bacterial or parasitic infection requiring
- cSSSI patients, the presence of decubitus ulcers, necrotizing fasciitis, gas gangrene,
or skeletal infection;
- CAP patients who have been hospitalized within 14 days before the onset of symptoms;
- CAP Patients: Presence of any of the following for patients with pneumonia:
- Postobstructive pneumonia.
- Pulmonary abscess.
- Known or suspected pulmonary infection with Pneumocystis carinii.
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