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

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: Carbapenem; Klebsiella Pneumonia
• Intervention / Treatment: Other: none intervention

• Study Type: Observational
• Enrollment (Actual): 144

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	mortality after 28 day from infection	28 day

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

General Publications

• De Pascale G, Martucci G, Montini L, Panarello G, Cutuli SL, Di Carlo D, Di Gravio V, Di Stefano R, Capitanio G, Vallecoccia MS, Polidori P, Spanu T, Arcadipane A, Antonelli M. Double carbapenem as a rescue strategy for the treatment of severe carbapenemase-producing Klebsiella pneumoniae infections: a two-center, matched case-control study. Crit Care. 2017 Jul 5;21(1):173. doi: 10.1186/s13054-017-1769-z.

Study record dates

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: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Pneumonia; Klebsiella Infections
• 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