NCT01659515No Longer Available不适用
Arbekacin Treatment of Adult Patients With Infections Caused by Multidrug-resistant Bacteria
U.S. Army Medical Research and Development Command1 个研究点 分布在 1 个国家开始时间: 2012年8月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
Arbekacin for the use of infection caused by multidrug-resistant organisms
详细描述
The primary purpose of this protocol is to make arbekacin available for treatment of patients with infections caused by multidrug-resistant organisms when treatment with other antibiotics cannot be used due to unavailability, intolerance, contraindications, or treatment non-response.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is military health care beneficiary at least 18 years of age;
- •Subject is a Walter Reed National Military Medical Center patient deemed by the primary medical or surgical team as having a bacterial infection of the respiratory tract, bloodstream, skin, soft tissue, bone, or genitourinary tract;
- •Subject is allergic to or intolerant of antibiotics to which the infective organism is susceptible; Or The use of antibiotics to which the subject's infective organism is susceptible is contraindicated; Or
- •Subject's infective organism isolate is a multidrug-resistant (MDR) bacterium defined as any of the following:
- •Gram-negative bacterium that is non-susceptible to all index antibiotics within 3 or more of 6 antibiotic classes including aminoglycosides (amikacin, gentamicin, tobramycin), beta-lactam/beta-lactam inhibitor combinations (piperacillin-tazobactam, amoxicillin-clavulanate), carbapenems (imipenem, ertapenem), fluoroquinolones (ciprofloxacin, levofloxacin), cephalosporins (ceftazidime, cefepime, ceftriaxone), and sulbactam (ampicillin-sulbactam);
- •Extended Spectrum β-lactamase (ESBL) producing Gram-negative bacterium;
- •Carbapenemase resistant Enterobacteriaceae;
- •Cephalosporin resistant Klebsiella species;
- •Methicillin-resistant Staphylococcus aureus (MRSA);
- •Vancomycin resistant Enterococcus species;
- •Staphylococcus aureus that is non-susceptible to vancomycin.
- •Subject's infective organism is inhibited in vitro by arbekacin at a concentration ≤ 4 μg/mL;
- •Subject is able to give written or witnessed verbal informed consent [An exception from the general requirements for informed consent can be made based upon the criteria specified in 21 Code of Federal Regulations 50.23 (a and c)];
- •Subject has adequate venous access for intravenous administration of arbekacin.
- •Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner, or sterile sexual partner) for at least 30 days prior to receipt of arbekacin and must agree to continue using such precaution for at least 30 days after last dose of arbekacin; the subject must also have a negative pregnancy test within 24 hours prior to initial dose of arbekacin.
排除标准
- •Subject has a history of allergy or serious adverse reaction to aminoglycoside antibiotics;
- •Subject is currently participating in another investigational new drug study.
- •Subject has a positive serum pregnancy test or is breast feeding.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Clinical significance of arbekacin for MRSA infection in patients with hematological malignancies based on the PK-PD indexMethicillin-resistant Staphylococcus aureus (MRSA) infection in patients with hematological malignancies (including probable cases).JPRN-UMIN000004426ihon University School of Medicine100
Unknown
不适用
Experimental Phage Therapy of Bacterial InfectionsBacterial InfectionsNCT00945087Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
已完成
不适用
Use of New Antibiotics in SwedenMulti-antibiotic ResistanceNCT05048693Uppsala University41
已完成
不适用
Prospective Study of Drug Resistant Pathogens Among Liver, Intestinal and Multivisceral Transplant RecipientsTransplantationNCT00235664University of Pittsburgh200
招募中
4 期
Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint InfectionProsthetic-joint InfectionInfection HipKnee, Joint InfectionNCT06172010Leiden University Medical Center316