CTRI/2019/07/020401尚未招募3 期
A Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter baumannii-calcoaceticus Complex
Entasis Therapeutics0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
- •Patients who meet all of the following general inclusion criteria, in addition to the specific inclusion criteria listed below for Parts A and B, will be eligible to participate in the study:
- •1.A signed informed consent form (ICF). If a study patient is unable to provide informed consent due to their medical condition, the patientâ??s legally authorized representative may consent on behalf of the study patient, as permitted by local law and institutional Standard Operating Procedures;
- •2.Male or female ï?³18 years of age;
- •3.A confirmed diagnosis of a serious infection and the expectation, in the judgment of the Investigator, that the patientâ??s infection will require treatment with IV antibiotics;
- •4.A known infection caused by ABC (bacteremia, HABP, VABP, cUTI or AP, or surgical or post traumatic wound infections) as either a single pathogen or member of a polymicrobial
- •infection based on evidence from culture or, if available, rapid diagnostic test from a sample collected within 72 hours prior to randomization (HABP/VABP patients), AND 1 of the following:
- •a.Has received no more than 48 hours of effective empiric therapy prior to enrollment; OR
- •b.Is clinically failing prior treatment regimens (ie, clinical deterioration or failure to improve after at least 48 hours of antibiotic treatment);
- •Note: Rapid testing of respiratory specimens utilizing FilmArray 2.0 BPP technology (see Section 7.7) may be used to enable early identification of ABC pneumonia. Patients can be randomized based on the results of the BPP rapid test while awaiting results of cultures from the local laboratory. However, if the respiratory sample does not grow ABC in the local microbiology laboratory culture, these patients will be withdrawn from the study drug treatment.
- •5.Expectation, in the judgment of the Investigator, that the patient will survive at least 72 hours with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study;
- •6.Women of childbearing potential (ie, not post-menopausal or surgically sterilized) must have a negative serum pregnancy test before randomization. Participating women of childbearing potential must be willing to consistently use 2 highly effective methods of contraception (ie, condom, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from Screening until at least 30 days after administration of the last dose of study drug; and
- •Male participants must be willing to use condoms during sexual intercourse from Screening until at least 90 days after administration of the last dose of study drug.
排除标准
- •Patients who meet any of the following criteria will be excluded from participation in the study:
- •1.Presence of suspected or confirmed deep-seated infection, including lung abscess in patients with pneumonia, that is not planned on being drained within 24 hours after randomization;
- •Note: Patients with an empyema who will have drainage within 24 hours of Screening and who are expected to be able to be treated with 14 or fewer days of antibiotics are allowed.
- •2.Evidence of active concurrent community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, respiratory syncytial virus, influenza and parainfluenza viruses, Middle East respiratory syndrome coronavirus, etc;
- •3.Presence of suspected or confirmed osteomyelitis, endocarditis, or meningitis, as determined by history and/or physical examination;
- •4.Irremovable implantable device or line thought to be the potential source of infection;
- •5.Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ï?³60 mmHg AND having a serum lactate >2 mmol/L (18 mg/dL) despite adequate volume resuscitation;
- •Note: Patients who can maintain an MAP ï?³60 mmHg on a reasonable dose of pressors or are weaning off of pressors may be considered. Patients who require more than the maximal dose of 2 vasopressors to maintain an MAP ï?³60 mmHg are ineligible. If vasopressors are weaned to below these levels, patient enrollment can be reconsidered.
- •6.For patients to be enrolled with the primary indication of HABP or VABP, any of the following conditions:
- •a.Diagnosis of ventilator-associated tracheobronchitis; or
- •b.Inability to provide proper respiratory specimens for culture. Respiratory samples from expectorated or induced sputum should show <10 squamous epithelial cells and >25 polymorphonuclear neutrophils per 100ï?´ field;
- •7.For patients to be enrolled with the primary indication of cUTI or AP, any of the following urologic conditions:
- •a.Likely to receive ongoing antibacterial drug prophylaxis after treatment of cUTI (eg, patients with vesico-uretal reflux);
- •b.Suspected or confirmed prostatitis;
- •c.Requirement for bladder irrigation with antibiotics or for antibiotics to be administered directly via urinary catheter;
- •d.Previous or planned cystectomy or ileal loop surgery;
- •e.Uncomplicated urinary tract infection (eg, female patients with urinary frequency, urgency, or pain or discomfort without systemic symptoms or signs of infection);
- •f.Complete, permanent obstruction of the urinary tract;
- •g.Suspected or confirmed perinephric or renal corticomedullary abscess;
- •h.Polycystic kidney disease; or
- •i.Any recent history of trauma to the pelvis or urinary tract;
- •8.Moribund patients or patients with evidence of immediately life-threatening disease where, in the opinion of the Investigator, the patient is unlikely to survive more than 72 hours after Day 1;
- •9.Pregnant or breastfeeding women;
- •10.APACHE II score >30 at the time of diagnosis of infection;
- •Note: For Part B, an APACHE II or SOFA score is only required if able to be calculated. A qSOFA score must be calculated for all patients without an APACHE II score. Glasgow coma score for APACHE II calculation should be t
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