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Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

Information source: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complicated Urinary Tract Infection; Pyelonephritis

Intervention: CXA-201 (Drug); Levofloxacin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cubist Pharmaceuticals

Official(s) and/or principal investigator(s):
Obiamiwe Umeh, M.D., MSc., Study Director, Affiliation: Cubist Pharmaceuticals


This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).

Clinical Details

Official title: A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population

Secondary outcome: The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.

Detailed description: Approximately 500 subjects will be enrolled into this study and randomized 1: 1 to receive CXA-201 or comparator (levofloxacin) resulting in 250 subjects per treatment arm. Subject participation will require a minimum commitment of 35 days and a maximum of 42 days. Subjects will be hospitalized for the administration of all doses of IV study therapy. A test of cure visit will occur at 7 days after the last dose of study drug and a late follow-up evaluation or contact will occur a minimum of 28 days and a maximum of 35 days after the last dose of study drug.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. Provide written informed consent prior to any study-related procedure not part of normal medical care (a legally acceptable representative may provide consent if the subject is unable to do so, provided this is approved by local country and institution specific guidelines). 2. Be males or females ≥ 18 years of age 3. If female, subject is non-lactating, and is either: 1. Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or 2. Of childbearing potential and is practicing a barrier method of birth control (e. g., a diaphragm or contraceptive sponge) along with 1 of the following methods: oral or parenteral contraceptives (for 3 months prior to study drug administration), or a vasectomized partner. Or, subject is practicing abstinence from sexual intercourse. Subjects must be willing to practice these methods for the duration of the trial and for at least 35 days after last dose of study medication. 4. Males are required to practice reliable birth control methods (condom or other barrier device) during the conduct of the study and for at least 35 days after last dose of study medication. 5. Pyuria (white blood cell [WBC] count > 10/μL in unspun urine or ≥ 10 per high power field in spun urine). 6. Clinical signs and/or symptoms of cUTI, either of: 1. Pyelonephritis, as indicated by at least 2 of the following:

- Documented fever (oral temperature > 38°C) accompanied by patient symptoms

of rigors, chills, or "warmth";

- Flank pain;

- Costovertebral angle tenderness or suprapubic tenderness on physical exam;


- nausea or vomiting; OR

2. Complicated lower UTI, as indicated by at least 2 of the following:

- At least 2 of the following new or worsening symptoms of cUTI:

- Dysuria; urinary frequency or urinary urgency;

- Documented fever (oral temperature > 38°C) accompanied by patient

symptoms of rigors, chills, or "warmth";

- Suprapubic pain or flank pain;

- Costovertebral angle tenderness or suprapubic tenderness on physical

exam; or

- Nausea or vomiting; plus,

- At least 1 of the following complicating factors:

- Males with documented history of urinary retention;

- Indwelling urinary catheter that is scheduled to be removed during IV

study therapy and before the EOT;

- Current obstructive uropathy that is scheduled to be medically or

surgically relieved during IV study therapy and before the EOT; or

- Any functional or anatomical abnormality of the urogenital tract

(including anatomic malformations or neurogenic bladder) with voiding disturbance resulting in at least 100 mL residual urine. 7. Have a pretreatment baseline urine culture specimen obtained within 24 hours before the start of administration of the first dose of study drug. NOTE: Subjects may be enrolled in this study and start IV study drug therapy before the Investigator knows the results of the baseline urine culture. 8. Require IV antibacterial therapy for the treatment of the presumed cUTI. Exclusion Criteria: 1. Have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam or quinilone antibacterial (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment) 2. Have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to IV study drug therapy. (Drugs with only gram-positive activity [e. g., vancomycin, linezolid] are allowed.) 3. Receipt of any amount of potentially therapeutic antibacterial therapy after collection of the pretreatment baseline urine culture and before administration of the first dose of study drug. 4. Receipt of any dose of a potentially therapeutic antibacterial agent for the treatment of the current UTI within 48 hours before the study-qualifying pretreatment baseline urine is obtained (exceptions: subjects with an active cUTI who have received prior antibiotics may be enrolled provided a minimum of 48 hours have elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for cUTI who present with signs and symptoms consistent with an active new cUTI may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture). 5. Intractable urinary infection at baseline that the Investigator anticipates would require more than 7 days of study drug therapy. 6. Complete, permanent obstruction of the urinary tract. 7. Confirmed fungal urinary tract infection at time of randomization (with ≥ 103 fungal CFU/mL). 8. Permanent indwelling bladder catheter or urinary stent including nephrostomy. 9. Suspected or confirmed perinephric or intrarenal abscess. 10. Suspected or confirmed prostatitis. 11. Ileal loop or known vesico-ureteral reflux. 12. Severe impairment of renal function including an estimated CrCl < 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine output over 24 hours). 13. Current urinary catheter that is not scheduled to be removed before the EOT (intermittent straight catheterization during the IV study drug administration period is acceptable). 14. Any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of study data. 15. Any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, respiratory failure, and septic shock. 16. Immunocompromising condition, including established AIDS, hematological malignancy, or bone marrow transplantation, or immunosuppressive therapy including cancer chemotherapy, medications for prevention of organ transplantation rejection, or the administration of corticosteroids equivalent to or greater than 40 mg of prednisone per day administered continuously for more than 14 days preceding randomization. 17. One or more of the following laboratory abnormalities in baseline specimens: aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase, or total bilirubin level greater than 3 times the upper limit of normal (ULN), absolute neutrophil count less than 500/μL, platelet count less than 40,000/μL, or hematocrit less than 20%. 18. Participation in any clinical study of an investigational product within 30 days prior to the proposed first day of study drug. 19. Previous participation in any study of CXA-101 or CXA-201. 20. Women who are pregnant or nursing.

Locations and Contacts

Rio de Janeiro, Brazil

Sao Paulo, Brazil

Armenia, Colombia

Barranquilla, Colombia

Bogota, Colombia

Kohtla-Jarve, Estonia

Tallinn, Estonia

Tartu, Estonia

Tbilsi, Georgia

Budapest, Hungary

Tatabánya, Hungary

Haifa, Israel

Jerusalem, Israel

Safed, Israel

Daugavpils, Latvia

Liepaja, Latvia

Riga, Latvia

Valmiera, Latvia

Ventspills, Latvia

Chihuahua, Mexico

San Luis Potosi, Mexico

Veracruz, Mexico

Chisinau, Moldova, Republic of

Brasov, Romania

Bucuresti, Romania

Iasi, Romania

Sibiu, Romania

Kemerovo, Russian Federation

Moscow, Russian Federation

Nizhniy Novgorod, Russian Federation

Novosibirsk, Russian Federation

Penza, Russian Federation

Saratov, Russian Federation

St. Petersburg, Russian Federation

Belgrade, Serbia

Banska Bystrica, Slovakia

Levice, Slovakia

Martin, Slovakia

Presov, Slovakia

Skalica, Slovakia

Chiang Mai, Thailand

Lop Buri, Thailand

Prachuap Khiri Khan, Thailand

Oradea, Bihor, Romania

Miskolc, Borsod-Abauj-Zemplen, Hungary

Bucharest, Bucuresti, Romania

Gyor, Budapest, Hungary

San Diego, California, United States

Wheat Ridge, Colorado, United States

Szentes, Csongrad, Hungary

Hialeah, Florida, United States

Bloemfontein, Free State, South Africa

Pretoria, Gauteng, South Africa

Soweto, Gauteng, South Africa

Sopron, Gyor-moson-sopron, Hungary

Giessen, Hessen, Germany

Guadalajara, Jalisco, Mexico

Belo Horizonte, Minas Gerais, Brazil

Middleburg, Mpumalanga, South Africa

Nakorn Ratchasima, Nakhon Ratchasima, Thailand

Teaneck, New Jersey, United States

Salgotarjan, Nograd, Hungary

Porto Alegre, Rio Grande de Sul, Brazil

Joinville, Santa Catarina, Brazil

Campinas, Sao Paulo, Brazil

Sao Jose de Rio Preto, Sao Paulo, Brazil

Lubeck, Schleswig-Holstein, Germany

Kfar Saba, Sharon, Israel

Charleston, South Carolina, United States

Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary

Petach Tikva, Teah Tiqwa, Israel

Tel Hashomer, Tel Aviv, Israel

Timisoara, Timis, Romania

Cali, Valle Del Cauca, Colombia

Bellville, Western Cape, South Africa

Zalaegerszeg, Zala, Hungary

Additional Information

Starting date: June 2011
Last updated: March 9, 2015

Page last updated: August 23, 2015

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