Ceftazidime-Avibactam for the treatment of infections due to Ceftazidime Resistant Pathogens
- Conditions
- cUTI, Complicated Urinary Tract Infection, cIAI, Complicated intra-abdominal infectionTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2012-000726-21-GR
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
1.>18 years of age inclusive
2.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 28 days after last infusion
3.Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, 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
1.Patient has an APACHE II score >30
2.Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)
3.Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
4.Patient is immunocompromised
5.Patient has a rapidly progressive or terminal illness, including acute hepatic failure or respiratory failure with a high risk of mortality due to other causes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method