A clinical study in patients with complicated infections of the urinary tract conducted to assess safety, tolerability and efficacy of the study drug (MK-7655) administered together with Imipenem/Cilastatin (an antibiotic) in comparison with Imipenem/Cilastatin administered alone
- Conditions
- Patients with Complicated Urinary Tract Infection at least 18 years of age, with a diagnosis of either complicated cUTI or acute pyelonephritisMedDRA version: 14.1Level: LLTClassification code 10046544Term: Urinary infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10001032Term: Acute pyelonephritisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2011-005707-32-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1. Patient is >=18 years of age on day of signing informed consent.
2. Patient or the patient's legal representative understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent for the trial.
3. Patient has been domiciled in a health care facility (e.g., hospital, nursing home) for at least 48 hours within the preceding 30 calendar days prior to signing informed consent.
4. Sexually active females of childbearing potential with a negative urine pregnancy test are eligible for enrollment; however, this must be followed up with a confirmed negative serum pregnancy test (B-HCG) as soon as possible (within 48 hours of the screening visit). A patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) a medically acceptable effective method of birth control for 1 month after study entry.
5. Patient has a clinically suspected and/or bacteriologically documented cUTI OR acute pyelonephritis judged by the investigator to be serious (requiring hospitalization and treatment with IV antibiotic therapy) according to the following disease definitions:
a)Acute pyelonephritis is defined as a systemic, ascending urinary tract infection in a patient with normal urinary tract anatomy, clinically manifested by meeting at least 2 of the following criteria: Fever (defined as >=38.0°C [>=100.4°F] orally OR an oral equivalent [>=38.5°C (>=101.3°F) by tympanic or rectal measurement]; Flank pain; Costovertebral angle (CVA) tenderness on physical examination; Nausea or vomiting
b) cUTI is defined as a clinical syndrome in men or women characterized by the development of at least 2 of the following local or systemic signs and symptoms: Local signs and symptoms: Dysuria, urinary frequency, suprapubic or pelvic pain, or urinary urgency. Systemic signs and symptoms: Fever (as defined above), chills or rigors (accompanied by fever), flank pain or CVA tenderness on physical examination.
The above symptoms must also occur in the presence of at least 1 of the following: Presence of indwelling urinary catheter or other urinary bladder instrumentation, Any functional or anatomical abnormality of the urogenital tract with voiding disturbance resulting in at least 100 mL of residual urine, Current obstructive uropathy that is scheduled to be medically or surgically relieved during IV study therapy,Males with documented history of urinary retention.
6. Patient has pyuria, determined by a midstream clean-catch (MSCC) or catheterized (indwelling or straight catheter) urine specimen with >=10 white blood cells (WBCs) per high-power field (hpf) on standard examination of urine sediment or >=10 WBCs/mm3 in unspun urine.
7. Patient has one positive urine culture within 48 hours of enrollment, defined as: >=10^5 CFU/mL of uropathogen either from a MSCC or indwelling catheter urine specimen, OR >=10^4 CFU/mL of uropathogen either from a MSCC or indwelling catheter urine specimen if blood culture is also positive, OR >=10^2 CFU/mL of uropathogen from a straight catheter specimen.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
1. Patient has complete obstruction of any portion of the urinary tract (requiring a
permanent indwelling urinary catheter or instrumentation), has a known ileal loop, or
intractable vesico-uretral reflux
2. Patient has a cUTI in whom a temporary indwelling urinary catheter is in place and
cannot be removed at study entry
NOTE: All indwelling urinary catheters must be removed prior to the start of IV
study therapy. It is also anticipated that an indwelling urinary catheter will not be
reinserted during the study (at least while on IV study therapy)
3. Patient has a perinephric or intrarenal abscess or known or suspected prostatitis
4. Patient has an uncomplicated UTI (e.g., a female patient with urinary frequency,
urgency or pain/discomfort without any risk factors for infection as outlined in
Inclusion Criteria #5b)
5. Patient has any history of recent accidental trauma to the pelvis or urinary tract
6. Patient has received any amount of effective antibiotic therapy (defined as therapy known to be active against the identified uropathogen) after obtaining the urine culture for admission to this study (admission urine culture) and prior to the
administration of the first dose of IV study therapy
7. Patient has an infection which has been treated with >24 hours of systemic antibiotic therapy known to be effective against the presumed or documented etiologic pathogen(s) within the 72-hour period immediately prior to consideration for entry into the study (only patients with a urine culture positive for the presence of at least 1 gram-negative enteric(s) and/or anaerobic pathogen(s) commonly isolated in UTI will be considered microbiologically evaluable)
NOTE: Patients on prophylactic antibiotic therapy should be enrolled only if their
admission culture is confirmed to be positive for at least 1 gram-negative enteric(s) and/or anaerobic pathogen(s) commonly isolated in UTI. Culture results must be available from those patients on prophylactic antibiotics prior to enrollment
NOTE: If a patient has received >24 hours of systemic antimicrobial therapy, there
must be clear evidence that the patient has failed this regimen or developed the cUTI
while on the previous antibiotic regimen. Such evidence would include new or
continued fever or persistence or worsening of symptoms related to the index infection and persistent positive cultures and persistent laboratory or radiographic changes (if previously present). These measures should be confirmed prior to study entry.
8. Patient has a history of serious allergy, hypersensitivity (e.g., anaphylaxis), or any
serious reaction to carbapenem antibiotics, any cephalosporins, penicillins, or other ?-
lactam agents
NOTE: Patients with history of mild rash to penicillins or other ?-lactams may be
enrolled and closely monitored
9. Patient has a history of serious allergy, hypersensitivity (e.g., anaphylaxis), or any
serious reaction to other ?-lactamase inhibitors (e.g., tazobactam, sulbactam,
clavulanic acid)
NOTE: Patients with history of mild rash to other ?-lactamase inhibitors may be
enrolled and closely monitored
10. Patient has a history of a seizure disorder
11. Patient is currently being treated with valproic acid or has received treatment with
valproic acid in the 2 weeks prior to screening
12. Patient has a rapidly progressive or terminal illness (unlikely to survive the
approximately 6- to 8-week study period)
13. Patient is pregnant or expecting to conceive, is breast feed
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