CTRI/2022/10/046306已完成3 期
A Phase 3, Multi-Center, Randomized, Open-Label, Assessor-Blind Study to Evaluate the Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Catheter-Related or Central Line Associated Bloodstream Infection
eonardMeron Biosciences Inc0 个研究点目标入组 66 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Subject or a legally authorized representative must provide a signed informed consent form;
- •2.Male or female ?18 years of age;
- •3.Subject must have a bloodstream infection with no other apparent source other than the CVC that meets one of the following criteria:
- •oA recognized single pathogen cultured from 1 or more blood cultures; OR
- •oA common skin contaminant cultured from 2 or more blood cultures drawn on the same or consecutive calendar days from a subject with fever ( >38.0ºC), chills, or hypotension (systolic blood pressure <90 mmHg);
- •NOTE: When possible, it is recommended to collect blood cultures from both the CVC and a peripheral venipuncture.
- •4.Inpatient or outpatient with presence of indwelling CVC (ie, totally implantable port, tunneled or non-tunneled CVC, hemodialysis catheter, or peripherally inserted CVC) that has been in place for ?5 days;
- •5.A bloodstream infection documented within 96 hours prior to enrollment (and from which an isolate of the baseline pathogen(s) is still available for analysis at the central laboratory) and demonstrates the protocol definition of CRBSI or CLABSI;
- •NOTE: Subjects may be enrolled and randomized while awaiting results of standard blood cultures from the local laboratory:
- •oIf an organism has been identified from blood specimen testing using an FDA-cleared rapid diagnostic test (eg, T2MR); or
- •oIf a positive blood culture specimen shows an organism by 1 of the following:
- •?Gram stain; or
- •?An FDA-cleared molecular rapid diagnostic test (eg, FilmArray BCID or Verigene);
- •If the pending blood culture does not confirm a qualifying organism by standard methods and an isolate is not available for testing at the central laboratory, the subject will be withdrawn from study drug treatment and managed at the Investigator’s discretion.
- •NOTE: Subjects with a positive blood culture identified up to 120 hours prior to enrollment and in whom an isolate of the baseline pathogen is still available for analysis at the central laboratory may be considered on a case by-case basis with prior approval from the Medical Monitor.
- •6.Subjects for whom, in the Investigator’s opinion, catheter retention for the duration of the study (6 weeks) is reasonable or required;
- •7.Female subjects of childbearing potential must have a negative urine and/or serum pregnancy test within 5 days prior to randomization;
- •NOTE: The following are considered women who are NOT of childbearing potential:
- •oPostmenopausal (defined as no menses for at least 12 consecutive months); or
- •oDocumented to be surgically sterile;
- •8.Female subjects of childbearing potential and male subjects who are sexually active must agree to use a highly effective method of contraception from the time of informed consent until 30 days post dose;
- •NOTE: Highly effective methods of contraception include hormonal contraceptives, intrauterine device, double-barrier method, partner sterility, or abstinence.
- •9.Male subjects must agree to refrain from sperm donation throughout the duration of the study and for 90 days following the last dose of study drug; and
- •10.Subject must be willing to comply with all study procedures, whether inpatient or outpatient, for the duration of the study.
排除标准
- •1.Subjects with hypersensitivity or allergy to tetracycline antibiotics or edetate disodium;
- •2.Subjects with septic shock that requires inotropic support or is unresponsive to fluid resuscitation;
- •3.Subjects taking disulfiram at the time of randomization or who are expected to take disulfiram at any time during treatment with study drug;
- •4.Subjects with prosthetic cardiac valves, vascular grafts, pacers, automatic implantable cardioverter-defibrillator, or other non-removable vascular foreign body, with the exception of coronary stents and peripheral stents. Subjects who underwent a coronary artery bypass graft >1 year prior to Screening AND with no known complications associated with the graft may be enrolled;
- •5.Subjects with the presence of a deep-seated intravascular source of infection (eg, endocarditis [as evidenced by vegetations on an echocardiogram or clinical suspicion] or septic thrombosis);
- •6.Subjects with bacteremia with documented microbiological evidence of another source of infection (eg, osteomyelitis, pneumonia, skin infection, urinary tract infection, joint infection, or abdominal infection) known to be due to the same organism cultured from the blood;
- •7.Subjects with polymicrobial CRBSI/CLABSI caused by pathogens that would require multiple antibiotics to be used for adequate lock therapy treatment. For example, a subject with methicillin-resistant Staphylococcus aureus (MRSA) and Escherichia coli requiring treatment with vancomycin and meropenem would be excluded from the study. A subject with S. aureus and S. epidermidis, where both are identified as pathogens and where both could be treated with vancomycin, would be eligible;
- •NOTE: If ?1 organism is isolated, the Investigator should decide which of the organisms are pathogens and require therapy. Isolates of all organisms should be sent to the central laboratory. In the event that the subject is being treated with more than 1 systemic SOC anti- infective, the Investigator will specify a single antibiotic that should be used for the antibiotic lock. It is acceptable for the SOC antibiotic lock to differ from the SOC anti- infectives, as necessary per local SOC.
- •8.Subjects with the presence of a tunnel or catheter exit site infection or an infusion port pocket abscess as manifested by purulence at the exit site, or inflammation with erythema, or induration of ?1 cm in diameter;
- •9.Subjects who have been previously randomized into the present study;
- •10.Subjects who are pregnant or breastfeeding;
- •11.Subjects with proven or suspected persistent bacteremia or fungemia despite 72 hours of both systemic anti-infective therapy and lock therapy to which the infecting organism is susceptible;
- •12.Subjects with short-term CVCs indwelling ?5 days;
- •13.Subjects with a central line-related mycobacterial infection or fungi other than Candida; or
- •14.Subjects who, in the opinion of the Investigator, have a high probability of death within 3 months of randomization due to a disease process other than the CRBSI/CLABSI.
研究者
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