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

March 28, 2017 updated by: Dr. Gennaro De Pascale, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

144

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients with severe CR-Kp infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Double Carbapenem Group
Patients underwent Double carbapenem treatment
Other: none intervention
none intervention
Standard Treatment Group
Patients who were not treated with the double carbapenem
Other: none intervention
none intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 28 day
mortality after 28 day from infection
28 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSC14669/15 359/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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