Status Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
Active DE4280C00002 2011-005721-43

Studientitel: 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

Purpose / Objectives

Diagnosis

  • Harnwegsinfekte (English name missing)

cUtI or Pyelonephritis

Target population

Inclusion criteria

1. Patient must provide a signed written informed consent prior to any study-specific procedures.

2. Patient must be 18 to 90 years of age, inclusive.

3. Patient has a clinically suspected and/or bacteriologically documented cUTI or acute pyelonephritis judged by the investigator to be serious (requires patient to be hospitalized for treatment with IV therapy).

4. Female patient is authorized to participate in this clinical study

5. Female patient is authorized to participate in this clinical study if at least one of the following criteria are met. Surgical sterilization, (eg, bilateral oophorectomy and/or bilateral salpingectomy,but excluding bilateral tubal occlusion)

 

 

 

 

Exclusion criteria

1. A Gram stain demonstrates that a Gram-positive organism is present, or if urine culture results are available, demonstrates Gram-positive organisms are present at ≥105 CFU/mL.

2. Where a urine culture result is available, at least 1 Gram-negative uropathogen is resistant to CAZ-AVI or doripenem.

3. Where a urine culture result is available, patient’s urine culture at study entry isolates more than 2 microorganisms regardless of the colony count.

4. Where a urine culture result is available, patient has a confirmed fungal UTI with colony count >103 CFU/mL.

5. Patient has received any prior antibiotic before the initiation of study therapy for this infection.

 

Study design

  • Phase III
  • Multicenter
  • Two-arm
  • Double-blind

Intervention

Avibactam vs. Doripenem

Documents (password protected)

Networks

Responsibilities in overall study

Sponsor

AstraZeneca GmbH

(National) Coordinating Investigator

Prof. Dr. med. Marc-Oliver Grimm