Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to Methicillin-Resistant Staphylococcus aureus MedDRA version: 8.1 Level: LLT Classification code 10052596 Term: Nosocomial pneumonia
Conditions
Sponsors
Theravance, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be eligible for study enrollment. 1. Male and female patients = 18 years old. 2. Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic-care facility, or acquired within 7 days after being discharged from a hospitalization of = 3 days duration. 3. A chest radiograph with findings consistent with a diagnosis of pneumonia (new or progressive infiltrates, consolidation, or pleural effusion) within 48 hours prior to randomization in the study. 4. Availability of appropriate respiratory or sputum specimens for Gram stain and culture, and venous access for IV dosing. 5. Willing to receive IV therapy for the duration of treatment. 6. Informed consent can be obtained for participation in this study as defined by the local Institutional Review Board or Ethics Committee. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who satisfy any of the following criteria are not eligible for study enrollment. 1. a) Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization, (unless documented to be a treatment failure or if the isolated pathogen for the current pneumonia was resistant in vitro to previous treatment), and/or b) Requires non-study systemic antibiotic potentially effective against the baseline pathogen for another reason during the study 2. Respiratory tract specimens or sputum with only Gram-negative bacteria seen on Gram stain or culture. 3. Known infection with MSSA or S. pneumoniae and patient will require more than 24 hours of concomitant study medication therapy with an antibiotic for Gram-negative coverage that has activity versus MSSA or S. pneumoniae (e.g., piperacillin-tazobactam). 4. Known or suspected pulmonary disease that precludes evaluation of therapeutic response (e.g., granulomatous diseases, lung cancer, or another malignancy metastatic to the lungs); cystic fibrosis or active tuberculosis. 5. Known or suspected Legionella pneumophila pneumonia. 6. Known or suspected infection with an organism that is not susceptible to medications permitted by the protocol should be excluded. 7. Documented or suspected meningitis, endocarditis, or osteomyelitis. 8. Refractory shock defined as supine systolic blood pressure 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or requirement for sympathomimetic agents to maintain blood pressure. 9. Baseline QTc > 500 msec, congenital long QT syndrome, uncompensated heart failure, or uncorrected abnormal K+ or Mg++ blood levels that cannot be corrected. 10. Severely neutropenic (absolute neutrophil count < 500/mm³) or anticipated to develop severe neutropenia during the study treatment period due to prior or planned chemotherapy, or have HIV with CD4 count < 100/mm³ during the last 6 months 11. Requirement for concomitant administration of intravenous Sporanox® (itraconazole) or Vfend® (voriconazole), Geodon® (ziprasidone), or any other medication containing a cyclodextrin solubilizer 12. a) Female patients of childbearing potential if they are pregnant, nursing, or unable to use a highly effective method of birth control during the study and for at least one complete menstrual cycle following the last dose of study medication. A negative serum pregnancy result must be documented prior to treatment. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or a vasectomized partner. b) Male patients must agree to use medically acceptable birth control for a least three months following last dose of study medication. A vasectomy or a condom used with a spermicide is a medically acceptable birth control method for males. 13. Prior enrollment in a clinical trial of telavancin. 14. Known hypersensitivity to, or intolerance of, study medications or their formulation excipients. 15. Treatment with another investigational medication within 30 days of study entry 16. Considered unlikely to survive at least 7 days due to underlying illness 17. Considered unlikely to comply with the study procedures or to return for scheduled post-treatment evaluations. 18. Any other conditi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of telavancin to vancomycin in the treatment of adults with Gram-positive hospital-acquired pneumonia (HAP) with an emphasis on patients with infections due to methicillin-resistant Staphylococcus aureus (MRSA).;Secondary Objective: To pool the data from this study with those from a second study of identical design (protocol 0019) and to assess the superiority of telavancin to vancomycin in patients with MRSA infection.;Primary end point(s): The primary efficacy endpoint is the clinical response at the Test-of-Cure evaluation. For purpose of analysis, assessments of “failure” at End-of-Therapy will be carried forward to Test-of-Cure. | — |
Countries
Belgium, Czech Republic, Germany, Italy, Malta, Slovakia, United Kingdom
Outcome results
None listed