NCT00454272已完成4 期
Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- The primary efficacy parameter will be the Response
研究概览
简要总结
The aim of the study is to evaluate the efficacy and safety of Teicoplanin versus Vancomycin as part of the initial antibiotic regimen in the therapy of patients with fever and neutropenia .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Will initiate study drug treatment in the hospital;
- •Has a life expectancy exc. 1 month.Is male or a non-pregnant, non-lactating female, who is post-menopausal, surgically sterilized; or has been using one or more birth control methods for at least two months prior to study entry.
- •Effective contraception must continue for at least 30 days after treatment discontinuation;
排除标准
- •Has a history of suspected or documented Type I hypersensitivity reaction (e.g. anaphylactic or anaphylactoid shock, respiratory distress from bronchospasm or rash) to glycopeptides (vancomycin or teicoplanin), aminoglycosides, b-lactams or cephalosporins
- •Has renal dysfunction requiring dialysis ;
- •Has neutropenia associated with a syndrome that is not generally thought to be associated with a high risk of bacterial infection (e.g., chronic benign neutropenia);
- •Is in blast crisis of chronic myeloid leukemia;
- •Has a known underlying immunocompromising disease likely to interfere with the evaluation of therapeutic response, such as infection with human immunodeficiency virus (HIV) ;
- •Had isolation and identification of a specific pathogen suspected to be responsible for fever ;Has documented colonization with vancomycin-resistant Enterococcus faecium or with Enterococcus faecalis
- •Had received more than one dose of a systemic (whether oral or parenteral) antibiotic within 3 calendar days preceding the initial therapy for this episode of fever;
- •Has received oral vancomycin for prophylaxis of Gram-positive infection;
- •Requires addition of anti-viral, anti-anaerobic or anti-fungal coverage at the same time as study medication; however, antiviral or antifungal prophylaxis is allowed, provided that it is not started at the same time than study medication.
- •Has suspected, invasive fungal disease (e.g. image of necrotic pneumonia), peri-rectal infection, liver abscess, or necrotizing enterocolitis (typhlitis).
- •Had a negative serum or urine laboratory pregnancy test (for all women except those post-menopausal or surgically sterilized).
- •The patient has one of the following:Leukemia, lymphoma, Hodgkin's disease, solid tumors or who had undergone bone marrow transplantation (for any reason)
- •Had neutropenia at the time of initiation of initial empiric antibiotic therapy, defined as <500 neutrophils/mm3 of blood; or if ³500 but <1,000 neutrophils/mm3 and expected to fall below 500 neutrophils/mm3 within 48 hours.
- •Has at least one of the following conditions:
- •clinically obvious, serious catheter-related infections. For a patient with documented catheter-related infection due to an organism other than coagulase negative staphylococci, the catheter has been removed within 24 hours of identification (removal over a guidewire is permitted).
- •Intensive chemotherapy that produces substantial mucosal damage (i.e., high-dose cytarabine (> 1 g/m2/day, which increases the risk for penicillin resistant streptococcal infections, particularly those due to viridans streptococci);
- •prophylaxis with quinolones before the onset of the febrile episode; known colonization with pneumococci that are resistant to penicillin and -cephalosporins or methicillin-resistant S. aureus; a blood culture positive for gram-positive bacteria before final identification and susceptibility
研究组 & 干预措施
1, Vancomycin
Active Comparator
Vancomycin
干预措施: Vancomycin (Drug)
2, Teicoplanin
Active Comparator
Teicoplanin
干预措施: Teicoplanin (Drug)
结局指标
主要结局
The primary efficacy parameter will be the Response
时间窗: 4 to 6 days after study drug discontinuation.
次要结局
- Safety will be assessed for all randomized patients who received at least one dose(1 month after the last dose of the drug)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patientseutropenic and febrile patients with hematological or solid tumors, who are at high risk for gram-positive bacterial infection.MedDRA version: 17.1Level: PTClassification code 10060945Term: Bacterial infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-004628-23-Outside-EU/EEASanofi190
终止
3 期
Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue InfectionsSkin Diseases, InfectiousSoft Tissue InfectionsNCT00430937Novartis Pharmaceuticals194
已完成
2 期
Comparison between effects of Teicoplanin versus Vancomycin in treatment of catheter infection in hemodialysis patientshemodialysis patients who had catheter infection.Other infectious diseasesA00-B99IRCT138903234144N2Semnan university of medical sciences43
已完成
3 期
A comparison of therapeutic effects of teicoplanin versus vancomycin in patients admitted to the Intensive Care Unit after cardiac surgeryEndocarditis.Acute endocarditis, unspecifiedIRCT2016022220592N4Shahid Beheshti University of Medical Sciences46
已完成
1 期
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisNCT01085760Mayo Clinic35