Status:
COMPLETED
Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Urinary Tract Infections
Pyelonephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125 mg or 250 mg doses of MK-7655 (relebactam) to imipenem/cilastatin in adults 18 years or older with complica...
Eligibility Criteria
Inclusion
- \- 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)
- \- Pyuria, determined by a midstream clean-catch (MSCC) or catheterized
- (indwelling or straight catheter) urine specimen with greater than or equal to 10 white blood cells (WBCs) per high-power field (hpf) on standard examination of urine sediment or greater than or equal to 10 WBCs/mm3 in unspun urine
- \- One positive urine culture within 48 hours of enrollment
Exclusion
- \- Complete obstruction of any portion of the urinary tract (requiring a
- permanent indwelling urinary catheter or instrumentation), a known ileal loop, or intractable vesico-ureteral reflux
- A temporary indwelling urinary catheter is in place and cannot be removed at study entry.
- Perinephric or intrarenal abscess or known or suspected prostatitis
- Uncomplicated UTI
- Any history of recent accidental trauma to the pelvis or urinary tract
- Any amount of effective antibiotic therapy after obtaining the urine culture for admission to this study and prior to the administration of the first dose of IV study therapy
- An infection which has been treated with greater than 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
- History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any
- serious reaction to carbapenem antibiotics, any cephalosporins, penicillins, or other beta (β)-lactam agents
- History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to other beta-lactam inhibitors (e.g., tazobactam, sulbactam, clavulanic acid)
- History of a seizure disorder
- Currently being treated with valproic acid or has received treatment with
- valproic acid in the 2 weeks prior to screening.
- Rapidly progressive or terminal illness unlikely to survive the approximately 6 to 8 week study period
- Pregnant or expecting to conceive, breast feeding, or plans to breast feed
- during the study
- \- A response to all study therapy (IV study therapy or subsequent oral
- ciprofloxacin) within the timeframe of treatment specified in this protocol is
- considered unlikely.
- \- Concurrent infection that would interfere with evaluation of response to
- the study antibiotics
- \- Need for concomitant systemic antimicrobial agents in addition to those
- designated in the various study treatment groups (use of vancomycin, daptomycin, or linezolid is allowed for certain infections)
- cUTI due to a confirmed fungal pathogen
- Currently receiving immunosuppressive therapy, including use of high-dose
- corticosteroids
- Prior recipient of a renal transplantation
- Laboratory abnormalities as specified in protocol
- History of any other illness that, in the opinion of the investigator, might
- confound the results of the study or pose additional risk in administering the study drug
- \- Currently participating in, or has participated in, any other clinical study
- involving the administration of investigational or experimental medication (not
- licensed by regulatory agencies) at the time of presentation or during the previous 30 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial
- \- Estimated or actual creatinine clearance of \<5 mL/minute, or is currently undergoing hemodialysis
Key Trial Info
Start Date :
May 16 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2015
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT01505634
Start Date
May 16 2012
End Date
July 28 2015
Last Update
May 24 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.