CTRI/2025/10/096642尚未招募4 期
A phase 4, Muliticenter,Open-Label study to Evaluate the Safety, Tolerability and Efficacy of Cefepime and Enmetazobactam combination in adult Indian Subjects with cUTI including AP, HAP including VAP and Bacteremia associated with these conditions
Orchid Pharma Limited14 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年11月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 14
- 主要终点
- Incidence and severity of AEs and SAEs, vital signs, laboratory tests, electrocardiogram (ECGs), and physical examinations
研究概览
简要总结
This will be a phase 4, multi-center, open-label study to assess safety and efficacy of Cefepime 2 gm and Enmetazobactam 500 mg Dry Powder for Injection in Indian adult subjects diagnosed with cUTI including AP and/or HAP including VAP and /or bacteremia associated with these condition. The study will be conducted at multiple sites across India.All enrolled patients will be treated for a minimum of 7 days; however, treatment may continue for up to 14 days for patients with a positive blood culture at baseline at the discretion of the Investigator. A Test of Cure (TOC) visit will occur 7 days after End of Treatment (EOT) (EOT + 7 days [±2 days]) for patients receiving 7 days of treatment and 19 days after randomization (randomization + 19 days [±2 days]) for patients receiving more than 7 days of treatment. Patients will be evaluated for primary endpoint till TOC and for secondary endpoints on Day 3, EOT, TOC, and LFU or ET. Patients will be monitored for safety throughout the duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Adult male or female patients more than and equal to 18 or less than and equal to 75 years of age
- •Patients who will be able to sign the informed consent voluntarily prior to any study-specific procedures.
- •Subject diagnosed with cUTI including AP and/or HAP including VAP and/or bacteremia associated with these conditions will require hospitalization and initial treatment with at least 7 days of intravenous (IV) antibiotics.
- •Subjects with suspected infection with ESBL-producing organisms susceptible to Cefepime+Enmetazobactam (for patients clinically suspected with Gram-negative infections, perform both Rapid test and standard culture test to confirm ESBL status).
- •Female subjects of childbearing potential must have a negative urine pregnancy test within 1 day prior to study entry.
- •Male and female subjects of childbearing potential must agree to use highly effective contraception methods to avoid pregnancy during the study period.
- •Subjects shall receive a test dose of the study drug, and only those who do not exhibit hypersensitivity shall proceed with the treatment Meet the following clinical criteria for complicated urinary tract infection including acute pyelonephritis: Have at least two of the following new-onset or worsening symptoms or signs: • Fever, defined as oral temperature greater than or equal to thirty-eight degrees Celsius (greater than or equal to one hundred point four degrees Fahrenheit), observed and documented by a health care provider within twenty-four hours of Screening; • Nausea or vomiting within twenty-four hours of Screening reported by the patient; • Dysuria, increased urinary frequency, or urinary urgency; • Lower abdominal, suprapubic, or pelvic pain; • Evidence of pyuria within forty-eight hours prior to enrolment.
- •Have at least one of the following complicating factors for complicated urinary tract infection: • Documented history of urinary retention in male patients (for example, benign prostatic hypertrophy); • Use of intermittent bladder catheterization or presence of an indwelling bladder catheter; • Azotemia, defined as blood urea nitrogen greater than twenty milligrams per deciliter, blood urea greater than forty-two point eight milligrams per deciliter, or serum creatinine greater than one point four milligrams per deciliter, due to known prior intrinsic renal disease; • Any functional or anatomical abnormality of the urogenital tract with voiding disturbance resulting in at least one hundred milliliters of residual urine; • Current obstructive uropathy that is scheduled to be medically or surgically relieved during intravenous study therapy and before end of treatment.
- •Have the following criteria for acute pyelonephritis: • Acute flank pain (onset within seven days prior to randomization) or costovertebral angle tenderness on physical examination; • Dysuria, increased urinary frequency, or urinary urgency; • Fever, defined as oral temperature greater than or equal to thirty-eight degrees Celsius (greater than or equal to one hundred point four degrees Fahrenheit), observed and documented by a health care provider within twenty-four hours of Screening; • Nausea or vomiting within twenty-four hours of Screening reported by the patient; • Evidence of pyuria within forty-eight hours prior to enrolment.
- •White blood cell count greater than ten cells per cubic millimeter in unspun urine or greater than ten cells per high-power field in spun urine sediment; or urinalysis/dipstick analysis positive for leukocyte esterase.
- •And/or Meet the following clinical criteria for hospital-acquired pneumonia or ventilator-associated pneumonia:
- •Have at least one of the following onset or worsening criteria: • New onset or worsening of pulmonary symptoms and signs; • New onset or worsening of purulent respiratory secretions; • Hypoxemia; • Need for acute changes in ventilator support.
- •Have at least one of the following clinical criteria: • Documented fever (defined as body temperature greater than or equal to thirty-eight degrees Celsius, or one hundred point four degrees Fahrenheit); • Hypothermia (defined as body temperature less than or equal to thirty-five degrees Celsius, or ninety-five degrees Fahrenheit); • White blood cell count greater than or equal to ten thousand cells per cubic millimeter or less than or equal to four thousand five hundred cells per cubic millimeter; • Greater than fifteen percent immature neutrophils (bands).
- •Have new or worsening infiltrate on a pulmonary imaging study that is consistent with bacterial pneumonia within forty-eight hours prior to randomization.
- •Have a lower respiratory tract specimen sent for Gram stain and quantitative culture within thirty-six hours prior to the first dose of study drug.
- •And/or Meet the following criterion for bacteremia: Diagnostic Criteria:
- •Blood Culture: a) Positive blood culture or cultures for bacteria, with the organism identified and reported by a microbiology laboratory, or positive Gram stain or other blood tests (such as white blood cell count, Procalcitonin, or C-Reactive Protein).
- •Typically, at least two sets of blood cultures (each set including an aerobic and an anaerobic bottle) should be obtained to confirm the diagnosis and to rule out contamination.
排除标准
- •Exclusion Criteria Patients meeting any of the following criteria will be excluded from the study: Patients with known or suspected disease or condition that, in the opinion of the Investigator, may confound the assessment of efficacy.
- •Receipt of potentially effective systemic antibacterial therapy for a continuous duration of more than twenty-four hours during the previous seventy-two hours before the study-qualifying baseline urine is obtained.
- •Exceptions: a.
- •Receipt of up to twenty-four hours of a short-acting antibacterial agent (not more than twenty-five percent of subjects who meet this criterion will be enrolled).
- •Subjects who received prior antimicrobial therapy for the current complicated urinary tract infection (cUTI) and/or acute pyelonephritis (AP) and: • In the Investigator’s opinion, failed that prior antibiotic therapy (that is, presented with worsening signs and symptoms); and • Documented to have cUTI caused by a pathogen that is non-susceptible to the prior antibiotic therapy; and • The causative pathogen is likely to be susceptible to the study drug.
- •Subjects who received antibacterial drugs for surgical prophylaxis and subsequently developed cUTI and/or AP.
- •Subjects who have received antimicrobial prophylaxis for recurrent cUTI and/or AP and then presented with signs and symptoms consistent with an active new cUTI and/or AP.
- •Subjects with culture resistant to Cefepime plus Enmetazobactam.
- •Subjects with rapidly progressive or terminal illness with a high risk of mortality due to any cause, including but not limited to acute hepatic failure, respiratory failure, cardiovascular disease, or septic shock, such that the subject is unlikely to survive the study period.
- •History of significant hypersensitivity or allergic reaction to cefepime, piperacillin/tazobactam, any excipients used in the respective formulations, any beta-lactam antibiotics (for example, cephalosporins, penicillins, carbapenems, or monobactams), or any beta-lactamase inhibitors (for example, tazobactam, sulbactam, or clavulanic acid).
- •Pulmonary disease that, in the Investigator’s judgment, would preclude evaluation of therapeutic response (for example, lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection, or recent pulmonary embolism).
- •Subjects with lung abscess, pleural empyema, or post-obstructive pneumonia.
- •Abnormal liver function test results including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or total bilirubin level greater than three times the upper limit of normal, or presence of liver cirrhosis.
- •Impairment of renal function with estimated glomerular filtration rate (eGFR) less than thirty millilitres per minute per 1.73 square metres, calculated by the four-variable Modification of Diet in Renal Disease (MDRD) equation.
- •Abnormal laboratory findings including platelet count less than fifty thousand per microlitre, absolute neutrophil count less than one thousand per cubic millimetre, or haemoglobin less than eight grams per decilitre.
- •Urinary tract surgery within seven days prior to enrolment or urinary tract surgery planned during the study period.
- •Pneumonia known or suspected to be caused by viruses, atypical bacteria, or fungi.
- •Presence of confounding respiratory conditions.
- •Subjects receiving extracorporeal membrane oxygenation (ECMO).
- •Subjects with refractory septic shock.
- •Subjects with active immunosuppression.
- •Suspected or confirmed acute bacterial prostatitis, orchitis, epididymitis, or chronic bacterial prostatitis as determined by history and/or physical examination.
- •Subjects currently participating in another clinical study or who participated in another clinical study involving any of the current study product within the last thirty days prior to enrolment.
- •Subjects with major cardiovascular disorders, including uncontrolled hypertension.
- •Subjects with symptoms suggestive of colitis.
结局指标
主要结局
Incidence and severity of AEs and SAEs, vital signs, laboratory tests, electrocardiogram (ECGs), and physical examinations
时间窗: Day 1 to Day 14, EOT, TOC, and LFU/ET
次要结局
- cUTI including AP(1.To evaluate proportion of subjects with clinical outcome of cure or improvement at EOT, TOC and LFUin terms of clinical cure.)
研究者
Dr Sagar Bhalerao
Lifepoint Multispeciality Hospital
研究点 (14)
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