Ceftolozane/tazobactam (MK-7625A) versus Meropenem in Pediatric Complicated Urinary Tract Infectio
- Conditions
- Treatment of complicated urinary tract infection (cUTI), including pyelonephritisMedDRA version: 20.0Level: LLTClassification code 10037606Term: Pyelonephritis, unspecifiedSystem Organ Class: 100000004862MedDRA version: 20.0Level: LLTClassification code 10046576Term: Urinary tract infection, site not specifiedSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2016-004153-32-Outside-EU/EEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
1. Have a legally acceptable representative who provides documented informed consent/assent for the trial.
2.Be a male or female from birth (defined as >32 weeks gestational age and =7 days postnatal) to <18 years of age
3.Be able to comply with the protocol for the duration of the trial
4.Require IV antibacterial therapy for the treatment of cUTI
5.Have a pretreatment baseline urine culture specimen obtained within 48 hours before the start of administration of the first dose of study treatment and preferably prior to administration of any potentially therapeutic antibiotics. Specimen is to be obtained by suprapubic aspiration, clean intermittent urethral catheterization, indwelling urethral catheter, or midstream clean catch
6.Have pyuria, defined as dipstick analysis positive for leukocyte esterase, OR:
a) If =1 year of age: White blood cell (WBC) count >10 cells/µL in unspun urine or =10 cells/high power field in spun urine
b) If <1 year of age: WBC count >5 cells/µL in unspun urine or =5 cells/high power field in spun urine
7.Have clinical signs and/or symptoms of cUTI (pyelonephritis or cLUTI) at the Screening Visit as described in the protocol
8.Meet one of the following categories: a)The subject is a male who is not of reproductive potential, defined as a male who has azoospermia (whether due to being prepubertal, having had a vasectomy, or an underlying medical condition) b)The subject is a female who is not of reproductive potential, defined as a female who either: (1) Has not undergone menarche; (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening, or (3) has a congenital or acquired condition that prevents childbearing
c)The subject is a female or a male of reproductive potential who agrees to avoid becoming pregnant or impregnating partner during screening, while receiving study treatment, and for at least 30 days after the last dose of study treatment by complying with one of the following: (1) Practice abstinencea from heterosexual activity OR (2) use (or have their partner use) acceptable contraception during heterosexual activity. Refer to the protocol for the acceptable methods of contraception
9.Meet the following criteria for a female subject who is of reproductive potential: a)The subject is not pregnant (as confirmed by serum pregnancy test at screening) and not planning to become pregnant within 30 days of the last day of study treatment administration b)The subject is nonlactating
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days prior to the first dose of study treatment in this current trial
2.Has previously participated in any trial of ceftolozane or ceftolozane/tazobactam or has enrolled previously in the current trial and been discontinued
3.Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that, in the opinion of the investigator, might expose the subject to increased risk by participating in the trial, confound the results of the trial, or interfere with the subject’s participation for the full duration of the trial
4.Has a history of any moderate or severe hypersensitivity (eg, anaphylaxis), allergic reaction, or other contraindication to any of the following: ß-lactam antibiotics (eg, penicillins, cephalosporins and carbapenems), or ß-lactamase inhibitors (eg, tazobactam, sulbactam, clavulanic acid, avibactam)
5.Has a history of a cUTI within the past 1 year prior to randomization that is caused by a pathogen known to be resistant to either IV study treatment
6.Has a concomitant infection at the time of randomization that requires nonstudy systemic antibacterial therapy in addition to IV study treatment or oral step -down therapy (medications with only gram-positive activity [eg, vancomycin, linezolid] are allowed)
7.Has received potentially therapeutic antibacterial therapy (eg, with gram negative activity), including bladder infusions with topical urinary antiseptics or antibacterial agents, for a duration of more than 24 hours during the 48 hours preceding the first dose of study treatment
8.Has any of the following: a)Intractable UTI or pyelonephritis infection at baseline that the Investigator anticipates would require more than 14 days of study treatment b)Confirmed fungal urinary tract infection at time of randomization with =103 fungal CFU/mL c)Permanent indwelling bladder catheter or instrumentation including nephrostomy d)Current urinary catheter that is not scheduled to be removed before the end of all study treatment (intermittent straight catheterization during the study treatment period is acceptable) e)Complete, permanent obstruction of the urinary tract f)Suspected or confirmed perinephric or intrarenal abscess g)Documented ileal loop reflux h) Suspected or confirmed prostatitis, urethritis, or epididymitis i)Trauma to pelvis/urinary tract
9.Has moderate or severe impairment of renal function, defined as an estimated creatinine clearance (CrCL) <50 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration
10.Has one or more of the following laboratory abnormalities in a specimen obtained at baseline: a)Absolute neutrophil count (ANC) <1000/mm3 b)Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =3 × the upper limit of normal (ULN) c)Total bilirubin =2 × ULN (if 7 to =28 days of age and breastfeeding, total bilirubin >10 mg/dL OR =2 × ULN)
11.Has a seizure disorder or is anticipated to be treated with divalproex sodium or valproic acid during the course of study treatment
12. Is receiving, or is expected to receive, any of the following medications:
a) Immunosuppressive agents
b) Valproic acid or divalproex sodium
c) Probenecid
13.Has any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, re
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method