NCT03094494

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

3.2 years

First QC Date

March 23, 2017

Last Update Submit

March 28, 2017

Conditions

CarbapenemKlebsiella Pneumonia

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    mortality after 28 day from infection

    28 day

Study Arms (2)

Double Carbapenem Group

Patients underwent Double carbapenem treatment

Other: none intervention

Standard Treatment Group

Patients who were not treated with the double carbapenem

Other: none intervention

Interventions

none interventionOTHER

none intervention

Double Carbapenem GroupStandard Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients with severe CR-Kp infection

You may qualify if:

  • age ≥ 18 years;
  • ICU admission between November 2012 and December 2015;
  • documented CR-Kp invasive infection;
  • targeted antibiotic therapy lasting ≥ 72 hours

You may not qualify if:

  • Klebsiella infection, susceptible to carbapenems
  • Duration of antimicrobial therapy less than 72 hours
  • Data not completely available from the electronically medical chart

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28679413DERIVED

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 23, 2017

First Posted

March 29, 2017

Study Start

November 1, 2012

Primary Completion

December 31, 2015

Study Completion

December 31, 2016

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share