Please assess the completion status of the following clinical trial:

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

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. 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.~2. Male or female ≥18 years of age.~3. Weight ≤185 kilograms (kg).~4. 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.~5. 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);~  * Elevated white blood cell count (\>10,000/mm\^3), or left shift (\>15% immature PMNs);~  * Nausea or vomiting;~  * Dysuria, increased urinary frequency, or urinary urgency;~  * Flank pain;~  * Costo-vertebral angle tenderness on physical examination~   Pyuria evidenced by 1 of the following:~  * Positive LCE on urinalysis;~  * White blood cell count ≥10 cells/mm\^3 in unspun urine;~  * White blood cell count ≥10 cells/hpf in urine sediment~6. Expectation, in the judgment of the Investigator, that any indwelling urinary catheter or instrumentation (including nephrostomy tubes and/or indwelling stents) will be removed or replaced (if removal is not clinically acceptable) before or as soon as possible, but not longer than 12 hours, after randomization.~7. Expectation, in the judgment of the Investigator that the participant will survive with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study.~8. Women of childbearing potential must have a negative pregnancy test before randomization and be willing to use a highly effective method of contraception between randomization and for 7 days after the completion of the study. A highly effective method of contraception includes 2 of the following: hormonal implants/patch, injectable hormones, oral hormonal contraceptives, prior bilateral oophorectomy, prior hysterectomy, prior bilateral tubal ligation, intra-uterine device, approved cervical ring, condom, true abstinence (if approved by the Investigator), or a vasectomized partner.~9. Willingness to comply with all the study procedures, whether in the hospital or after discharge, for the duration of the study.~Exclusion Criteria:~1. Presence of any of the following conditions:~   1. Perinephric abscess;~  2. Renal corticomedullary abscess;~  3. Uncomplicated urinary tract infection;~  4. Polycystic kidney disease;~  5. Chronic vesicoureteral reflux;~  6. Previous or planned renal transplantation;~  7. Participants receiving hemodialysis;~  8. Previous or planned cystectomy or ileal loop surgery; or~  9. Known candiduria.~2. Presence of suspected or confirmed acute bacterial prostatitis, orchitis, epididymitis, or chronic bacterial prostatitis as determined by history and/or physical examination.~3. Gross hematuria requiring intervention other than administration of study drug.~4. 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).~5. Renal function at screening as estimated by creatinine clearance \<50 mL/minute (min) using the Cockcroft-Gault formula.~6. Known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization.~7. Any of the following signs of severe sepsis:~   1. 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;~  2. Hypothermia (temperature \<35.6°C or \<96.1°F); or~  3. 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.~8. Pregnant or breastfeeding women.~9. History of epilepsy or known seizure disorder requiring current treatment with anti-seizure medication.~10. Treatment within 30 days prior to enrollment with valproic acid.~11. Treatment within 30 days prior to enrollment with probenecid.~12. Treatment within 30 days prior to enrollment with any cancer chemotherapy, immunosuppressive medications for transplantation, or medications for rejection of transplantation.~13. Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy.~14. Aspartate aminotransferase or alanine aminotransferase \>5 × ULN or total bilirubin \>3 × ULN.~15. Receipt of any potentially therapeutic antibiotic agent within 48 hours before randomization. Participants with a pathogen-causing cUTI or AP that is resistant to the prior therapy may be enrolled in this study (assuming the organism is known to be sensitive to piperacillin/tazobactam). Participants who develop signs and symptoms of cUTI or AP while on antibiotics may also be enrolled.~16. Prior exposure to vaborbactam alone or in combination with another product.~17. Receipt of any potentially therapeutic antibiotic agent within 48 hours before randomization.~    EXCEPTIONS:~   * Participants who received a single dose of a short-acting oral or IV antibiotic (an antibiotic that is typically dosed every 4 hours, every 6 hours, or q8h in a participant with normal renal function). No more than 25% of participants will be enrolled who meet this criterion.~   * Participants who received \>48 hours of prior systemic antibiotic therapy for the current episode of cUTI with unequivocal clinical evidence of treatment failure (that is, worsening signs and symptoms).~   * Participants who develop signs and symptoms of cUTI or AP while on antibiotics for another indication.~18. Requirement at time of enrollment for any reason for additional systemic antibiotic therapy (other than study drug) or antifungal therapy. Topical antifungal or a single oral dose of any antifungal treatment for vaginal candidiasis will be allowed.~19. Likely to require the use of an antibiotic for cUTI prophylaxis during the participant's participation in the study (from enrollment through the last follow up visit).~20. Known history of human immunodeficiency virus infection and known recent cluster of differentiation 4 count \<200/mm\^3.~21. Presence of immunodeficiency or an immunocompromised condition including hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long-term (≥2 weeks) use of systemic corticosteroids.~22. Presence of neutropenia (\<1,000 PMNs/mm\^3).~23. Presence of thrombocytopenia (\<60,000 platelets/mm\^3).~24. A corrected QT with Fridericia's Formula \>480 milliseconds.~25. History of significant hypersensitivity or allergic reaction to meropenem/vaborbactam, piperacillin/tazobactam, any of the excipients used in the respective formulations, or any beta-lactam antibiotics (such as, cephalosporins, penicillins, carbapenems, or monobactams).~26. Known hypersensitivity or inability to tolerate all of the following: fluoroquinolones (including levofloxacin), trimethoprim/ sulfamethoxazole, cefdinir, cefixime, or cefpodoxime, based on prescribing information.~27. Unable or unwilling, in the judgment of the Investigator, to comply with the protocol.~28. An employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, or a family member of the employee or the Investigator.~29. Acute Physiology and Chronic Health Evaluation II score \>30 (if clinically indicated)~30. Inability to tolerate intravenous fluids, due to medical reasons, of 1050 mL per day required for study drug administration.~31. Any recent history of trauma to the pelvis or urinary tract.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Meropenem-Vaborbactam (Type: EXPERIMENTAL): Meropenem-vaborbactam (meropenem 2 grams \[g\] plus vaborbactam 2 g), infused in 250 milliliters (mL) normal saline, administered intravenously (IV) over 3 hours, every 8 hours (q8h), with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-milligram (mg) dose every 24 hours (q24h) after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
- Piperacillin-Tazobactam (Type: ACTIVE_COMPARATOR): Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete