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Completed

NCT Number: NCT01599806

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

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

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Key information

Conditions

Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Rosario, Argentina

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceftazidime - Avibactam ( CAZ-AVI)

Drug

Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes

Doripenem

Drug

500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes

Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)

Drug

Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)

Drug

Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

Primary outcomes

  1. Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test

    Time frame: At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.

    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)).

  2. Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    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)).

  3. Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    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.

Secondary outcomes

  1. Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)

    Time frame: 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

    Number of patients with a favorable per-patient microbiological response at EOT (IV)

  2. Per-patient Microbiological Response at LFU (mMITT Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.

    Number of patients with a favorable per patient microbiological response at LFU

  3. Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)

    Time frame: 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

    Number of patients with a favorable per-patient microbiological response at EOT (IV)

  4. Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    Number of patients with a favorable per patient microbiological response at TOC

  5. Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.

    Number of patients with a favorable per patient microbiological response at LFU

  6. Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)

    Time frame: 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

    Number of patients with a favorable per-patient microbiological response at EOT (IV)

  7. Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    Number of patients with a favorable per patient microbiological response at TOC

  8. Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.

    Number of patients with a favorable per patient microbiological response at LFU

  9. Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)

    Time frame: 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

    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.

  10. Investigator Determined Clinical Response at TOC (mMITT Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    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.

  11. Investigator Determined Clinical Response at LFU (mMITT Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.

    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.

  12. Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)

    Time frame: 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

    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.

  13. Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    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.

  14. Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.

    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.

  15. Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)

    Time frame: 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

    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.

  16. Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    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.

  17. Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.

    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.

  18. Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)

    Time frame: 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

    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.

  19. Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    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.

  20. Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.

    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.

  21. Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    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.

  22. Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    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.

  23. Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    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.

  24. Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.

  25. Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.

  26. Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    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.

  27. Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)

    Time frame: 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.

    Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.

  28. Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)

    Time frame: 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.

    Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.

  29. Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)

    Time frame: 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.

    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.

  30. Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)

    Time frame: 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.

    Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.

  31. Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)

    Time frame: 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

    Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set

  32. Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization

    Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set

  33. Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization

    Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set

  34. Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)

    Time frame: 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

    Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set

  35. Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set

  36. Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.

    Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set

  37. Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)

    Time frame: 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

    Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set

  38. Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set

  39. Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.

    Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set

  40. Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)

    Time frame: 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

    Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only

  41. Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization

    Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only

  42. Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization

    Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only

  43. Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)

    Time frame: 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

    Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only

  44. Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only

  45. Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.

    Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only

  46. Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)

    Time frame: 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

    Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only

  47. Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.

    Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only

  48. Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)

    Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.

    Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only

  49. Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization

    Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set

  50. Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization

    Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set

  51. Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization

    Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set

  52. Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization

    Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set

  53. Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization

    Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set

  54. Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)

    Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization

    Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set

  55. Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)

    Time frame: within 15 minutes before/after dose

    Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.

  56. Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)

    Time frame: Between 30 to 90 minutes after dose

    Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.

  57. Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)

    Time frame: Between 300 to 360 minutes after dose

    Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.

  58. Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)

    Time frame: within 15 minutes before/after dose

    Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.

  59. Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)

    Time frame: Between 30 to 90 minutes after dose

    Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.

  60. Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)

    Time frame: Between 300 to 360 minutes after dose

    Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Forest Laboratories

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 16, 2012
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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