Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis Clinical Trial
Official title:
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults
| Verified date | August 2017 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis
| Status | Completed |
| Enrollment | 598 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - 18 to 90 years of age inclusive - Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after - Has pyuria with >/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing >/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem) - Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis. Exclusion Criteria: - Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem - Patient's urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI - Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant - Patient is immunocompromised - Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | Córdoba | |
| Argentina | Research Site | Corrientes | |
| Argentina | Research Site | Mendoza | |
| Argentina | Research Site | Santa Fe | |
| Brazil | Research Site | Belo Horizonte | |
| Brazil | Research Site | Campinas/SP | |
| Brazil | Research Site | Salvador | |
| Brazil | Research Site | São José do Rio Preto - SP | |
| Brazil | Research Site | São Paulo | |
| Brazil | Research Site | Vila Clementino | |
| Bulgaria | Research Site | Pleven | |
| Bulgaria | Research Site | Ruse | |
| Bulgaria | Research Site | Sofia | |
| Croatia | Research Site | Zagreb | |
| Czechia | Research Site | Kyjov | |
| Czechia | Research Site | Opava | |
| Germany | Research Site | Jena | |
| Germany | Research Site | Wuppertal | |
| Greece | Research Site | Athens | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Nagykanizsa | |
| Hungary | Research Site | Nyíregyháza | |
| Hungary | Research Site | Zalaegerszeg | |
| Israel | Research Site | Jerusalem | |
| Israel | Research Site | Petach-Tikva | |
| Israel | Research Site | Safed | |
| Japan | Research Site | Fukuoka-shi | |
| Japan | Research Site | Koshigaya-shi | |
| Japan | Research Site | Kyoto-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Nara-shi | |
| Japan | Research Site | Oita-shi | |
| Japan | Research Site | Sendai-shi | |
| Japan | Research Site | Sunto-gun | |
| Japan | Research Site | Tokushima-shi | |
| Japan | Research Site | Ueda-shi | |
| Japan | Research Site | Utsunomiya-shi | |
| Korea, Republic of | Research Site | Busan | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Wonju | |
| Mexico | Research Site | Guadalajara, Jalisco | |
| Poland | Research Site | Inowroclaw | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Warszawa | |
| Portugal | Research Site | Lisboa | |
| Romania | Research Site | Brasov | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Bucuresti | |
| Romania | Research Site | Cluj | |
| Romania | Research Site | Craiova | |
| Romania | Research Site | Iasi | |
| Russian Federation | Research Site | Arkhangelsk | |
| Russian Federation | Research Site | Krasnodar | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Penza | |
| Russian Federation | Research Site | Rostov-on-Don | |
| Russian Federation | Research Site | Saratov | |
| Russian Federation | Research Site | St. Petersburg | |
| Russian Federation | Research Site | St.Petersburg | |
| Russian Federation | Research Site | Vsevolozhsk | |
| Serbia | Research Site | Belgrade | |
| Serbia | Research Site | Kragujevac | |
| Slovakia | Research Site | Poprad | |
| Slovakia | Research Site | Presov | |
| Slovakia | Research Site | Trnava | |
| Slovakia | Research Site | Zilina | |
| Taiwan | Research Site | Chiayi | |
| Taiwan | Research Site | Taipei | |
| Turkey | Research Site | Diyarbakir | |
| Ukraine | Research Site | Cherkasy | |
| Ukraine | Research Site | Dnipropetrovsk | |
| Ukraine | Research Site | Kharkiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Lviv | |
| Ukraine | Research Site | Mykolaiv | |
| Ukraine | Research Site | Odesa | |
| Ukraine | Research Site | Odessa | |
| Ukraine | Research Site | Uzhhorod | |
| Ukraine | Research Site | Zaporizhzhya | |
| United States | Research Site | Lima | Ohio |
| United States | Research Site | Royal Oak | Michigan |
| United States | Research Site | Sylmar | California |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer | Forest Laboratories |
United States, Argentina, Brazil, Bulgaria, Croatia, Czechia, Germany, Greece, Hungary, Israel, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Taiwan, Turkey, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). | At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time. | |
| Primary | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Primary | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set. | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | Number of patients with a favorable per-patient microbiological response at EOT (IV) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Per-patient Microbiological Response at LFU (mMITT Analysis Set) | Number of patients with a favorable per patient microbiological response at LFU | At LFU visit. LFU visit is 45 to 52 days from Randomization. | |
| Secondary | Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Number of patients with a favorable per-patient microbiological response at EOT (IV) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) | Number of patients with a favorable per patient microbiological response at TOC | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) | Number of patients with a favorable per patient microbiological response at LFU | At LFU visit. LFU visit is 45 to 52 days from Randomization. | |
| Secondary | Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Number of patients with a favorable per-patient microbiological response at EOT (IV) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) | Number of patients with a favorable per patient microbiological response at TOC | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set) | Number of patients with a favorable per patient microbiological response at LFU | At LFU visit. LFU visit is 45 to 52 days from Randomization. | |
| Secondary | Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Investigator Determined Clinical Response at TOC (mMITT Analysis Set) | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Investigator Determined Clinical Response at LFU (mMITT Analysis Set) | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At LFU visit. LFU visit is 45 to 52 days from Randomization. | |
| Secondary | Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At LFU visit. LFU visit is 45 to 52 days from Randomization. | |
| Secondary | Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At LFU visit. LFU visit is 45 to 52 days from Randomization. | |
| Secondary | Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set) | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set) | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set) | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | At LFU visit. LFU visit is 45 to 52 days from Randomization. | |
| Secondary | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set) | Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry. | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature = 37.8 C in a 24-hour period. | |
| Secondary | Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set) | Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry. | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature = 37.8 C in a 24-hour period. | |
| Secondary | Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set) | Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry. | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature = 37.8 C in a 24-hour period. | |
| Secondary | Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set) | Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry. | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature = 37.8 C in a 24-hour period. | |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set | At TOC visit. TOC visit is 21 to 25 days from Randomization | |
| Secondary | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set | At LFU visit. LFU visit is 45 to 52 days from Randomization | |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set | At LFU visit. LFU visit is 45 to 52 days from Randomization. | |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set | At LFU visit. LFU visit is 45 to 52 days from Randomization. | |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only | At TOC visit. TOC visit is 21 to 25 days from Randomization | |
| Secondary | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only | At LFU visit. LFU visit is 45 to 52 days from Randomization | |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only | At LFU visit. LFU visit is 45 to 52 days from Randomization. | |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | |
| Secondary | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only | At TOC visit. TOC visit is 21 to 25 days from Randomization. | |
| Secondary | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only | At LFU visit. LFU visit is 45 to 52 days from Randomization. | |
| Secondary | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set | At TOC visit. TOC visit is 21 to 25 days from Randomization | |
| Secondary | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set | At TOC visit. TOC visit is 21 to 25 days from Randomization | |
| Secondary | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set | At TOC visit. TOC visit is 21 to 25 days from Randomization | |
| Secondary | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set | At TOC visit. TOC visit is 21 to 25 days from Randomization | |
| Secondary | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set | At TOC visit. TOC visit is 21 to 25 days from Randomization | |
| Secondary | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set | At TOC visit. TOC visit is 21 to 25 days from Randomization | |
| Secondary | Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | within 15 minutes before/after dose | |
| Secondary | Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | Between 30 to 90 minutes after dose | |
| Secondary | Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | Between 300 to 360 minutes after dose | |
| Secondary | Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | within 15 minutes before/after dose | |
| Secondary | Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | Between 30 to 90 minutes after dose | |
| Secondary | Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | Between 300 to 360 minutes after dose |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01599806 -
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
|
Phase 3 |