Double Carbapenem as Rescue Strategy for the Treatment of Carbapenemase-Producing Klebsiella Pneumoniae Infections

Klebsiella Pneumonia Clinical Trial

Official title:

Double Carbapenem as Rescue Strategy for the Treatment of Severe Carbapenemase-Producing Klebsiella Pneumoniae Infections: A Two-Center Matched Case-Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094494
• Other study ID #: UCSC14669/15 359/2015
• Status: Completed
• Phase: N/A
• First received: March 23, 2017
• Last updated: March 28, 2017
• Start date: November 1, 2012
• Est. completion date: December 31, 2016

Study information

• Verified date: March 2017
• Source: Policlinico Universitario Agostino Gemelli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An observational two-center case-control study exploring the clinical impact of double-carbapenem use in a population of critically il patients with severe carbapenem-resistant Klebsiella pneumoniae infection

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age = 18 years;

2. ICU admission between November 2012 and December 2015;

3. documented CR-Kp invasive infection;

4. targeted antibiotic therapy lasting = 72 hours

Exclusion Criteria

1. Klebsiella infection, susceptible to carbapenems

2. Duration of antimicrobial therapy less than 72 hours

3. Data not completely available from the electronically medical chart

Related Conditions & MeSH terms

• Carbapenem
• Klebsiella Infections
• Klebsiella Pneumonia
• Pneumonia

Intervention

Other:
• none intervention
none intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Universitario Agostino Gemelli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	mortality after 28 day from infection	28 day