EUCTR2004-002902-31-SK进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to Methicillin-Resistant Staphylococcus aureus - N/A
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 746
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •Patients who satisfy any of the following criteria are not eligible for study enrollment.
- •1. 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 have not responded to at least 3 days of treatment
- •or if the isolated pathogen for the current pneumonia was resistant in vitro
- •to previous treatment), For patients with renal impairment who have received one or more doses of vancomycin during the last week prior to the enrollment, please contact the Study Physician Helpline to determine eligibility.
- •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.
- •7. Documented or suspected meningitis, endocarditis, or osteomyelitis.
- •8. Refractory shock defined as supine systolic blood pressure < 90 mm Hg for > 2 hours with evidence of hypoperfusion or requirement for high-dose sympathomimetic agents (dopamine = 10 µg/kg/min or norepinephrine 0.1 µg/kg/min).
- •9. Baseline QTc > 500 msec, congenital long QT syndrome, uncompensated heart
- •failure, or 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), 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
研究者
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