Ceftazidime-Avibactam for the treatment of infections due to Ceftazidime Resistant Pathogens

Phase 1

• Conditions: cUTI, Complicated Urinary Tract Infection, cIAI, Complicated intra-abdominal infection; MedDRA version: 16.1 Level: LLT Classification code 10046574 Term: Urinary tract infection NOS System Organ Class: 100000004862; MedDRA version: 16.1 Level: LLT Classification code 10056570 Term: Intra-abdominal infection System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-000726-21-GB
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-31
• Study Completion: 2014-09-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 333

Inclusion Criteria

- Patient must be =18 and =90 years of age
– 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
- Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 256
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 144

Exclusion Criteria

- Patient has an APACHE II score >30 (cIAI patients only)
- Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)
- Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised
- Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified