Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C3591013 | Other Identifier | Alias Study Number |
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The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | NXL/104 ceftazidime |
|
| 2 | Active Comparator | comparator 4 x daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NXL104/ceftazidime | Drug | 125mg/500mg TID |
| |
| Imipenem/Cilastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit | Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required | End of IV therapy (4 to 14 days) |
| Clinical Outcome in CE Patients at the TOC Visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Carole A Sable, MD | Novexel Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Research Center | Birmingham | Alabama | 35209 | United States | ||
| Southeast Alabama Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23145859 | Derived | Vazquez JA, Gonzalez Patzan LD, Stricklin D, Duttaroy DD, Kreidly Z, Lipka J, Sable C. Efficacy and safety of ceftazidime-avibactam versus imipenem-cilastatin in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults: results of a prospective, investigator-blinded, randomized study. Curr Med Res Opin. 2012 Dec;28(12):1921-31. doi: 10.1185/03007995.2012.748653. Epub 2012 Nov 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NXL104/CAZ | NXL104 125mg/Ceftazidime 500mg TID |
| FG001 | Imipenem Cilastatin | Imipenem cilastatin 500mg 4xdaily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Drug |
4 x daily |
|
Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required |
| 5 to 9 days post-therapy |
| Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit | Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required | 4 to 6 weeks post-therapy |
| Microbiological Outcome in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) |
| Microbiological Outcome in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | 4 to 6 weeks post-therapy |
| Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) |
| Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) |
| Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) |
| Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) |
| Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) |
| Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy |
| Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy |
| Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy |
| Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy |
| Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy |
| Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | 4 to 6 weeks post-therapy |
| Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | 4 to 6 weeks post-therapy |
| Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | 4 to 6 weeks post-therapy |
| Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | 4 to 6 weeks post-therapy |
| Dothan |
| Alabama |
| 36301 |
| United States |
| Providence Hospital | Mobile | Alabama | 36608 | United States |
| Arizona Pulmonary Specialists LTD | Phoenix | Arizona | United States |
| Sharp Chula Vista Medical Center | Chula Vista | California | 91911 | United States |
| Synergy Clinical Research Center | Escondido | California | United States |
| Novellus Research Sites | Fountain Valley | California | United States |
| Novellus Research Sites | Long Beach | California | United States |
| Modesto Clinical Research | Modesto | California | United States |
| Tri City Medical Center | Oceanside | California | 92056 | United States |
| EStudy Site | San Jose | California | United States |
| Olive View UCLA Medical Center | Sylmar | California | United States |
| Christiana Care Health Services | Newark | Delaware | United States |
| Century Clinical Research, Inc | Daytona Beach | Florida | United States |
| University of Florida | Jacksonville | Florida | United States |
| Southeast Regional Research Group | Columbus | Georgia | United States |
| St. Joseph's/Candler Health System | Savannah | Georgia | United States |
| Four Rivers Clinical Research Inc | Paducah | Kentucky | United States |
| Louisiana State University Health Services Ctr Shreveport | Shreveport | Louisiana | 71103 | United States |
| R. Adams Cowley Shock Trauma Center | Baltimore | Maryland | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| North Memorial Medical Center | Minneapolis | Minnesota | 55422 | United States |
| Saint Louis University Hospital | St Louis | Missouri | United States |
| St. James Healthcare | Butte | Montana | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07754 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | United States |
| University Hospital UMDNJ | Newark | New Jersey | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Brookdale University Hospital | Brooklyn | New York | United States |
| Vassar Brothers Medical Center | Poughkeepsie | New York | United States |
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
| Mission Hospital | Asheville | North Carolina | United States |
| Clinical Trials of America Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Summa Health System Hospitals | Akron | Ohio | 44304 | United States |
| Remington-Davis | Columbus | Ohio | United States |
| Regional Infectious Disease-Infusion Center | Lima | Ohio | 45801 | United States |
| St Vincent's Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Thomas Jefferson Univ Hospital | Philadelphia | Pennsylvania | United States |
| Reading Hospital and Medical Center | West Reading | Pennsylvania | 19611 | United States |
| Harris Methodist | Azle | Texas | United States |
| University of Texas MD Anderson | Houston | Texas | United States |
| Sentara Norfold General Hospital | Norfolk | Virginia | United States |
| Al-Essra hospital | Amman | Jordan |
| Al-Islami Hospital | Amman | Jordan |
| Jordan University Hospital | Amman | Jordan |
| King Abdullah University Hospital | Irbid | Jordan |
| Clinique due Levant Hospital | Beirut | Lebanon |
| Dr. Rizk Clinic | Beirut | Lebanon |
| Makassed General Hospital | Beirut | Lebanon |
| Rafik Hariri University Hospital | Beirut | Lebanon |
| Sahel General Hospital | Beirut | Lebanon |
| Notre Dame Des Secours Hospital | Byblos | Lebanon |
| Ain Wazein Hospital | Chouf | Lebanon |
| St. Joseph Hospital | Ed Daoura | Lebanon |
| Mount Lebanon Hospital | Hazmiyeh | Lebanon |
| Nabatyeh Governmental Hospital | Nabatyeh | Lebanon |
| Hammoud Hospital University Medical Center | Saida | Lebanon |
| Labib Medical Center | Saida | Lebanon |
| Saida Governmental Hospital | Saida | Lebanon |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | NXL104/CAZ | NXL104 125mg/Ceftazidime 500mg TID |
| BG001 | Imipenem Cilastatin | Imipenem cilastatin 500mg 4xdaily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | 5 to 9 days post-therapy |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit | Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required | Posted | Number | Participants | End of IV therapy (4 to 14 days) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Outcome in CE Patients at the TOC Visit | Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required | Posted | Number | Participants | 5 to 9 days post-therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit | Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required | Posted | Number | Participants | 4 to 6 weeks post-therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | End of IV therapy (4 to 14 days) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | Posted | Number | Participants | 4 to 6 weeks post-therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | End of IV therapy (4 to 14 days) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | End of IV therapy (4 to 14 days) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | End of IV therapy (4 to 14 days) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | End of IV therapy (4 to 14 days) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | End of IV therapy (4 to 14 days) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | 5 to 9 days post-therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | 5 to 9 days post-therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | 5 to 9 days post-therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | 5 to 9 days post-therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | Posted | Number | Participants | 5 to 9 days post-therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | Posted | Number | Participants | 4 to 6 weeks post-therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | Posted | Number | Participants | 4 to 6 weeks post-therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | Posted | Number | Participants | 4 to 6 weeks post-therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | Posted | Number | Participants | 4 to 6 weeks post-therapy |
|
|
Baseline up to 19 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NXL104/CAZ | NXL104 125mg/Ceftazidime 500mg TID | 6 | 68 | 30 | 68 | ||
| EG001 | Imipenem Cilastatin | Imipenem cilastatin 500mg 4xdaily | 2 | 67 | 33 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Infusion Site Reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| C543519 | avibactam |
| D002442 | Ceftazidime |
| D000077728 | Cilastatin, Imipenem Drug Combination |
| ID | Term |
|---|---|
| D002509 | Cephaloridine |
| 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 |
| D015378 | Imipenem |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D015377 | Cilastatin |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
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