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Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections

Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01281462
Collaborator
(none)
217
Enrollment
50
Locations
3
Arms
19
Duration (Months)
4.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ceftaroline fosamil and NXL104 (q8h)
  • Drug: Ceftaroline fosamil and NXL104 (q12h)
  • Drug: Doripenem
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
217 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline Fosamil and NXL104 Versus Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infection
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ceftaroline fosamil and NXL104 (q8h)

Drug: Ceftaroline fosamil and NXL104 (q8h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);
Other Names:
  • Ceftaroline fosamil and Avibactam(NXL104) (q8h)

    • Drug: Placebo
    On CXL-MD-02, there were (3) treatment arms (meaning a subject could be randomized to 1 of 3 possible treatment regimens). Each treatment arm contained 1 or 2 placebo doses of IV saline in order to preserve the blind.
    Other Names:
  • placebo (saline)

    		•
    Experimental: Ceftaroline fosamil and NXL104 (q12h)

    Drug: Ceftaroline fosamil and NXL104 (q12h)
    600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);
    Other Names:
  • Ceftaroline fosamil and Avibactam(NXL104) (q12h)

    • Drug: Placebo
    On CXL-MD-02, there were (3) treatment arms (meaning a subject could be randomized to 1 of 3 possible treatment regimens). Each treatment arm contained 1 or 2 placebo doses of IV saline in order to preserve the blind.
    Other Names:
  • placebo (saline)

    		•
    Active Comparator: Doripenem

    Drug: Doripenem
    500 mg doripenem IV q8h;

    Drug: Placebo
    On CXL-MD-02, there were (3) treatment arms (meaning a subject could be randomized to 1 of 3 possible treatment regimens). Each treatment arm contained 1 or 2 placebo doses of IV saline in order to preserve the blind.
    Other Names:
  • placebo (saline)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC) [5 to 11 days after last dose of study drug]

      The number and percentage of subjects in each treatment group recorded as having a favorable microbiological response in the ME Population at Test-of-Cure (TOC)

    2. Evaluate safety [from administration of first dose of study drug to the Late -Follow -Up (LFU) visit (28 to 42 days after administration of the last dose of study drug)]

      Evaluate the safety of coadministered IV ceftaroline fosamil and NXL104 in subjects with cUTI. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology and coagulation studies, comprehensive metabolic panel, and urinalysis), vital signs, ECGs, and physical examinations will be provided for each treatment group.

    Secondary Outcome Measures

    1. Clinical response in CE at Test of Cure [5 to 11 days after last dose of study drug]

      The number and percentage of subjects in each treatment group classified as clinical cure Clinically Evaluable (CE) Population at TOC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Subjects must meet the following inclusion criteria:

    • Have pyuria (white blood cells in the urine)

    • Clinical signs and/or symptoms of cUTI (including acute pyelonephritis)

    • Have a pretreatment baseline urine culture specimen

    • The subject's infection would require initial treatment with IV antibiotics

    • The subject must require initial hospitalization to manage the cUTI by the standard of care.

    Exclusion Criteria:
    Subjects must NOT meet any of the following exclusion criteria:

    • History of any hypersensitivity or allergic reaction to any β-lactam (eg, cephalosporins, penicillins, carbapenems)

    • Confirmed fungal urinary tract infection

    • Intractable UTI anticipated to require more than 10 days of study drug therapy

    • Complete, permanent obstruction of the urinary tract\

    • Permanent indwelling bladder catheter or instrumentation (including nephrostomy) or current urinary catheter that will not be removed during IV study drug administration

    • Suspected or confirmed perinephric or intrarenal abscess

    • Suspected or confirmed prostatitis

    • Ileal loops or vesico-ureteral reflux

    • Impairment of renal function including a calculated CrCl of < 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria

    • Renal transplantation

    • Life expectancy less than 3 months

    • Evidence of significant hepatic, hematological, or immunologic disease or dysfunction

    • Past or current history of epilepsy or seizure disorder

    • Women who are pregnant or nursing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site La Mesa California United States 91942
    2 Investigational Site San Diego California United States 92120
    3 Investigational Site Pensacola Florida United States 32504
    4 Investigational Site Baltimore Maryland United States 21287
    5 Investigational Site Detroit Michigan United States 48202
    6 Investigational Site Plovdiv Bulgaria 4002
    7 Investigational Site Ruse Bulgaria 7002
    8 Investigational Site Sofia Bulgaria 1407
    9 Investigational Site Sofia Bulgaria 1431
    10 Investigational Site Sofia Bulgaria 1606
    11 Investigational Site Varna Bulgaria 9002
    12 Investigational Site Berlin Germany 10117
    13 Investigational Site Freiburg Germany 79106
    14 Investigational Site Gießen Germany 35385
    15 Investigational Site Kassel Germany 34125
    16 Investigational Site Minden Germany 32429
    17 Investigational Site Muellheim Germany 79379
    18 Investigational Site Paderborn Germany 33098
    19 Investigational Site Planegg Germany 82152
    20 Investigational Site Beirut Lebanon
    21 Investigational Site Bialystok Poland 15-950
    22 Investigational Site Bielsko-Biala Poland 43-316
    23 Investigational Site Częstochowa Poland 42-200
    24 Investigational Site Katowice Poland 40-073
    25 Investigational Site Katowice Poland 40-752
    26 Investigational Site Lodz Poland 90-153
    27 Investigational Site Tychy Poland 43-100
    28 Investigational Site Warszawa Poland 03-401
    29 Investigational Site Wolomin Poland 05-200
    30 Investigational Site Wrocław Poland 50-349
    31 Investigational Site Zamosc Poland 22-400
    32 Investigational Site Moscow Russian Federation 105077
    33 Investigational Site Moscow Russian Federation 105425
    34 Investigational Site Moscow Russian Federation 111123
    35 Investigational Site Moscow Russian Federation 119049
    36 Investigational Site Moscow Russian Federation 119992-119435
    37 Investigational Site Rostov-on-Don Russian Federation 344022
    38 Investigational Site Smolensk Russian Federation 214018
    39 Investigational Site St. Petersburg Russian Federation 193312
    40 Investigational Site St. Petersburg Russian Federation 194044
    41 Investigational Site St. Petersburg Russian Federation 194291
    42 Investigational Site St. Petersburg Russian Federation 194354
    43 Investigational Site St. Petersburg Russian Federation 195067
    44 Investigational Site St. Petersburg Russian Federation 196247
    45 Investigational Site St. Petersburg Russian Federation 198205
    46 Investigational Site St. Petersburg Russian Federation 199178
    47 Investigational Site Diyarbakir Turkey 21280
    48 Investigational Site Eskisehir Turkey 26480
    49 Investigational Site Izmir Turkey 35040
    50 Investigational Site Izmir Turkey 35340

    Sponsors and Collaborators

    • Forest Laboratories

    Investigators

    • Study Director: Medical Monitor, Forest Laboratories

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Forest Laboratories
    ClinicalTrials.gov Identifier:
    NCT01281462
    Other Study ID Numbers:
    • CXL-MD-02
    First Posted:
    Jan 24, 2011
    Last Update Posted:
    Feb 3, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by Forest Laboratories
    complicated Urinary Tract Infection
    Acute Pyelonephritis
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Urinary Tract Infections
    Ceftaroline fosamil
    Cephalosporins
    Doripenem
    Avibactam

    Study Results

    No Results Posted as of Feb 3, 2014