CTRI/2018/09/015762已完成3 期
A PHASE 3 PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL, CENTRAL ASSESSOR-BLINDED, PARALLEL GROUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OFAZTREONAM-AVIBACTAM (ATM-AVI) ± METRONIDAZOLE (MTZ) VERSUS MEROPENEM ± COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM-NEGATIVE BACTERIA, INCLUDINGMETALLO-?-LACTAMASE (MBL) – PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS - REVISIT
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 27
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
- •Inclusion Criteria:
- •All subjects:
- •1. Male or female from 18 years of age
- •2. Provision of informed consent
- •3. Confirmed diagnosis of HAP/VAP or cIAI requiring iv antibiotic treatment
- •4. Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance stated in the protocol are met and negative pregnancy
- •Additional for cIAI:
- •1. Diagnosis of cIAI, EITHER:
- •Intra-operative/postoperative enrolment with visual confirmation of cIAI. OR
- •Preoperative enrollment with evidence of systemic inflammatory response, physical and radiological findings consistent with cIAI; confirmation of cIAI at time of surgery within 24 hours of study entry
- •2. Surgical intervention within 24 hours (before or after) the administration of the
- •first dose of study drug
- •Additional for HAP/VAP:
- •1. Onset symptoms > 48h after admission to or <7 days after discharge from an inpatient
- •care facility
- •2. New or worsening infiltrate on CXR or CT scan
- •3. Clinical signs and symptoms and laboratory findings consistent with HAP/VAP
- •4. Respiratory specimen obtained for Gram stain and culture following onset of symptoms
- •and prior to randomisation
排除标准
- •All subjects:
- •1. APACHE II score > 30
- •2. Confirmed or suspected infection caused by Gram-negative species not expected to respond to study drug, or Gram-positive species
- •3. Receipt of >24 hr systemic antibiotic within 48h prior to randomisation (exception in case of treatment failure)
- •4. History of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to aztreonam, carbapenem, monobactam or other ß-lactam antibiotics, avibactam, nitroimidazoles or metronidazole, or any of the excipients of the study drugs
- •5. Known Clostridium difficle associated diarrhoea
- •6. Requirement for effective concomitant systemic antibacterials or antifungals
- •7. Creatinine clearance is equals to 15 ml per min or requirement or expectation for renal replacement therapy
- •8. Acute hepatitis, cirrhosis, acute hepatic failure, chronic hepatic failure
- •9. Hepatic disease as indicated by AST or ALT greater than 3 X ULN. Patients with AST and or or ALT up to 5 X ULN are eligible if acute and documented by the investigator as being directly related infectious process
- •10. Patient has a total bilirubin greater than 2 X ULN unless isolated hyperbilirubinemia is directly related to infectious process or due to known Gilberts disease.
- •11. ALP greater than 3 X ULN. Patients with values greater than 3 X ULN and Less than 5 X ULN are eligible if acute and directly related to the infectious process being treated
- •12. Absolute neutrophil count less than 500 per mm3.
- •13. Pregnant or breastfeeding or if of child bearing potential, not using a medically accepted effective method of birth control.
- •14. Any other condition that may confound the results of the study or pose additional risks to the subject
- •15. Unlikely to comply with protocol
- •16. History of epilepsy or seizure disorders excluding febrile seizures of childhood
- •Additional for cIAI
- •1. Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours of diagnosis; perforation of gastroduodenal ulcer with surgery < 24 h
- •2. Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess
- •3. Prior liver, pancreas or small-bowel transplant
- •4. Staged abdominal repair (STAR), open abdomen technique or marsupialisation
- •Additional for HAP/VAP
- •1. APACHE II score < 10
- •2. Known or high likelihood of Gram-positive monomicrobial infection
- •3. Lung abscess, pleural empyema, post-obstructive pneumonia
- •4. Lung or heart transplant
- •5. Myasthenia gravis
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