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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftaroline fosamil and NXL104 (q8h) | Experimental |
| |
| Ceftaroline fosamil and NXL104 (q12h) | Experimental |
| |
| Doripenem | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftaroline fosamil and NXL104 (q8h) | Drug | 600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h); |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC) | 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) | 5 to 11 days after last dose of study drug |
| Evaluate safety | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response in CE at Test of Cure | The number and percentage of subjects in each treatment group classified as clinical cure Clinically Evaluable (CE) Population at TOC | 5 to 11 days after last dose of study drug |
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Inclusion Criteria:
Subjects must meet the following inclusion criteria:
Exclusion Criteria:
Subjects must NOT meet any of the following exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | La Mesa | California | 91942 | United States | ||
| Investigational Site |
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| Ceftaroline fosamil and NXL104 (q12h) | Drug | 600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h); |
|
|
| Doripenem | Drug | 500 mg doripenem IV q8h; |
|
| Placebo | Drug | 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. |
|
|
| San Diego |
| California |
| 92120 |
| United States |
| Investigational Site | Pensacola | Florida | 32504 | United States |
| Investigational Site | Baltimore | Maryland | 21287 | United States |
| Investigational Site | Detroit | Michigan | 48202 | United States |
| Investigational Site | Plovdiv | 4002 | Bulgaria |
| Investigational Site | Rousse | 7002 | Bulgaria |
| Investigational Site | Sofia | 1407 | Bulgaria |
| Investigational Site | Sofia | 1431 | Bulgaria |
| Investigational Site | Sofia | 1606 | Bulgaria |
| Investigational Site | Varna | 9002 | Bulgaria |
| Investigational Site | Berlin | 10117 | Germany |
| Investigational Site | Freiburg im Breisgau | 79106 | Germany |
| Investigational Site | Giessen | 35385 | Germany |
| Investigational Site | Kassel | 34125 | Germany |
| Investigational Site | Minden | 32429 | Germany |
| Investigational Site | Müllheim | 79379 | Germany |
| Investigational Site | Paderborn | 33098 | Germany |
| Investigational Site | Planegg | 82152 | Germany |
| Investigational Site | Beirut | Lebanon |
| Investigational Site | Bialystok | 15-950 | Poland |
| Investigational Site | Bielsko-Biala | 43-316 | Poland |
| Investigational Site | Częstochowa | 42-200 | Poland |
| Investigational Site | Katowice | 40-073 | Poland |
| Investigational Site | Katowice | 40-752 | Poland |
| Investigational Site | Lodz | 90-153 | Poland |
| Investigational Site | Tychy | 43-100 | Poland |
| Investigational Site | Warsaw | 03-401 | Poland |
| Investigational Site | Wołomin | 05-200 | Poland |
| Investigational Site | Wroclaw | 50-349 | Poland |
| Investigational Site | Zamość | 22-400 | Poland |
| Investigational Site | Moscow | 105077 | Russia |
| Investigational Site | Moscow | 105425 | Russia |
| Investigational Site | Moscow | 111123 | Russia |
| Investigational Site | Moscow | 119049 | Russia |
| Investigational Site | Moscow | 119992-119435 | Russia |
| Investigational Site | Rostov-on-Don | 344022 | Russia |
| Investigational Site | Saint Petersburg | 193312 | Russia |
| Investigational Site | Saint Petersburg | 194044 | Russia |
| Investigational Site | Saint Petersburg | 194291 | Russia |
| Investigational Site | Saint Petersburg | 194354 | Russia |
| Investigational Site | Saint Petersburg | 195067 | Russia |
| Investigational Site | Saint Petersburg | 196247 | Russia |
| Investigational Site | Saint Petersburg | 198205 | Russia |
| Investigational Site | Saint Petersburg | 199178 | Russia |
| Investigational Site | Smolensk | 214018 | Russia |
| Investigational Site | Diyarbakır | 21280 | Turkey (Türkiye) |
| Investigational Site | Eskişehir | 26480 | Turkey (Türkiye) |
| Investigational Site | Izmir | 35040 | Turkey (Türkiye) |
| Investigational Site | Izmir | 35340 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| C543519 | avibactam |
| D000077726 | Doripenem |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015780 | Carbapenems |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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