Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP

Completed · Phase 3

Conditions studied: Urinary Tract Infection Complicated, Acute Pyelonephritis

In brief

Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).

Key facts

Study ID

NCT02166476

Run by

Melinta Therapeutics, Inc.

People needed

550

Starts

2014-11-20

Expected to finish

2016-04-28

Last updated by the study team

2018-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A signed informed consent form, the ability to understand the study conduct and tasks that are required for study participation, and a willingness to cooperate with all tasks, tests, and examinations as required by the protocol.
• Male or female ≥18 years of age.
• Weight ≤185 kilograms (kg).
• Expectation, in the judgment of the Investigator, that the participant's cUTI or AP requires initial treatment with at least 5 days of IV antibiotics.
• Documented or suspected cUTI or AP as defined below:
• cUTI
• Signs or symptoms evidenced by at least 2 of the following:
• Chills, rigors, or fever (fever must be documented within 24 hours of the screening visit with a temperature of ≥38.0 degrees Celsius [°C] [≥100.4 degrees Fahrenheit (°F)] or rectal/core temperature ≥38.3°C [≥100.9°F], observed and documented by a health care provider);
• Elevated white blood cell count (>10,000/ cubic millimeters [mm\^3]) or left shift (>15% immature polymorphonuclear leukocytes [PMNs]);
• Nausea or vomiting;
• Dysuria, increased urinary frequency, or urinary urgency;
• Lower abdominal pain or pelvic pain
• Pyuria evidenced by 1 of the following:
• Positive leukocyte esterase (LCE) on urinalysis;
• White blood cell count ≥10 cells/mm\^3 in unspun urine;
• White blood cell count ≥10 cells/high-power field (hpf) in urine sediment
• At least 1 of the following associated risks:
• Indwelling urinary catheter;
• Neurogenic bladder with presence or history of urine residual volume of ≥100 mL;
• Obstructive uropathy (such as, nephrolithiasis, tumor, fibrosis) that is expected to be medically or surgically treated within 48 hours post randomization;
• Azotemia due to intrinsic renal disease;
• Urinary retention in men due to previously diagnosed benign prostatic hypertrophy
• AP
• Signs or symptoms evidenced by at least 2 of the following:
• Chills, rigors, or fever (fever must be documented within 24 hours of the screening visit with a temperature of ≥38.0°C [≥100.4°F] or rectal/core temperature ≥38.3°C [≥100.9°F], observed and documented by a health care provider);

You may not qualify if…

• Presence of any of the following conditions:
• Perinephric abscess;
• Renal corticomedullary abscess;
• Uncomplicated urinary tract infection;
• Polycystic kidney disease;
• Chronic vesicoureteral reflux;
• Previous or planned renal transplantation;
• Participants receiving hemodialysis;
• Previous or planned cystectomy or ileal loop surgery; or
• Known candiduria.
• Presence of suspected or confirmed acute bacterial prostatitis, orchitis, epididymitis, or chronic bacterial prostatitis as determined by history and/or physical examination.
• Gross hematuria requiring intervention other than administration of study drug.
• Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy).
• Renal function at screening as estimated by creatinine clearance <50 mL/minute (min) using the Cockcroft-Gault formula.
• Known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization.
• Any of the following signs of severe sepsis:
• Shock or profound hypotension defined as systolic blood pressure <90 millimeters mercury (mmHg) or a decrease of >40 mmHg from baseline (if known) that is not responsive to fluid challenge;
• Hypothermia (temperature <35.6°C or <96.1°F); or
• Disseminated intravascular coagulation as evidenced by prothrombin time or partial thromboplastin time ≥2 × the upper limit of normal (ULN) or platelets <50% of the lower limit of normal.
• Pregnant or breastfeeding women.
• History of epilepsy or known seizure disorder requiring current treatment with anti-seizure medication.
• Treatment within 30 days prior to enrollment with valproic acid.
• Treatment within 30 days prior to enrollment with probenecid.
• Treatment within 30 days prior to enrollment with any cancer chemotherapy, immunosuppressive medications for transplantation, or medications for rejection of transplantation.
• Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy.

Where it is running

• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Tampa, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — Brest, Belarus
• Study site — Grodno, Belarus
• Study site — Homyel, Belarus
• Study site — Minsk, Belarus
• Study site — Minsk, Belarus
• Study site — Vitebsk, Belarus
• Study site — São José do Rio Preto, São Paulo, Brazil
• Study site — Belo Horizonte, Brazil
• Study site — Belo Horizonte, Brazil
• Study site — Campinas, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — São Paulo, Brazil
• Study site — Lovech, Bulgaria
• Study site — Montana, Bulgaria
• Study site — Silistra, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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