EUCTR2004-002904-13-ES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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 757
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. a) Received more than 24 hours of potentially effective systemic (IV/IM or PO)
- •antibiotic therapy 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 or imipenem).
- •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. Sustained shock defined as supine systolic blood pressure < 90 mm Hg for > 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.
- •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) 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 month 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 condition that in the opinion of an investigator, would confound or interfere with evaluation of safety
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