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Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation (IPANEMA-ECMO)

Primary Purpose

Catheter-Related Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vancomycine
Sponsored by
Universität des Saarlandes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter-Related Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult patients older than 18 years ECMO-Therapy Exclusion Criteria: patients younger than 18 years fever >38,5°C pregnancy antibiotic treatment with Vancomycine, Linezolid, Daptomycin or Tygacil on the day of liberation prior adverse events after application of Vancomycine

Sites / Locations

  • University Hospital of Saarland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention: Prophylactic antibiotic treatment

Control Arm: No prophylactic antibiotic treatment

Arm Description

Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation

Control group - no intervention.

Outcomes

Primary Outcome Measures

Growth of pathogens in blood culture
Detection of pathogens / blood stream infection
Growth of pathogens in blood culture
Detection of pathogens / blood stream infection

Secondary Outcome Measures

Growth of pathogens on cannula tip
Detection of growth of pathogens on cannulas
laboratory parameters
leukocytes, procalcitonin, C-reactive protein
laboratory parameters
leukocytes, procalcitonin, C-reactive protein
laboratory parameters
leukocytes, procalcitonin, C-reactive protein
laboratory parameters
leukocytes, procalcitonin, C-reactive protein

Full Information

First Posted
November 25, 2022
Last Updated
December 6, 2022
Sponsor
Universität des Saarlandes
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1. Study Identification

Unique Protocol Identification Number
NCT05651464
Brief Title
Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation
Acronym
IPANEMA-ECMO
Official Title
Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität des Saarlandes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this prospective interventional study is to evaluate the impact of antibiotic prophylaxis on bloodstream infections after liberation of extracorporeal membrane oxygenation therapy. The main questions aims to answer are: • does application of vancomycine prior to ECMO liberation have an impact of bloodstream infections? Participants will get 1 dose of vancomycine I.V. (15-20 mg per kgKG) prior to liberation of ECMO. Researchers will compare this interventional group to a group without antibiotic prophylaxis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Related Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Prophylactic antibiotic treatment
Arm Type
Active Comparator
Arm Description
Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation
Arm Title
Control Arm: No prophylactic antibiotic treatment
Arm Type
No Intervention
Arm Description
Control group - no intervention.
Intervention Type
Drug
Intervention Name(s)
Vancomycine
Intervention Description
Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation
Primary Outcome Measure Information:
Title
Growth of pathogens in blood culture
Description
Detection of pathogens / blood stream infection
Time Frame
taken 72 hours after liberation of extracorporeal membrane oxygenation therapy
Title
Growth of pathogens in blood culture
Description
Detection of pathogens / blood stream infection
Time Frame
taken directly before removal of extracorporeal membrane oxygenation therapy
Secondary Outcome Measure Information:
Title
Growth of pathogens on cannula tip
Description
Detection of growth of pathogens on cannulas
Time Frame
on the day of liberation, cannula tip will be send to institute of microbiology directly after liberation from ECMO
Title
laboratory parameters
Description
leukocytes, procalcitonin, C-reactive protein
Time Frame
6.00 am on the day of liberation of extracorporeal membrane oxygenation therapy
Title
laboratory parameters
Description
leukocytes, procalcitonin, C-reactive protein
Time Frame
24 hours after liberation of extracorporeal membrane oxygenation therapy
Title
laboratory parameters
Description
leukocytes, procalcitonin, C-reactive protein
Time Frame
48 hours after liberation of extracorporeal membrane oxygenation therapy
Title
laboratory parameters
Description
leukocytes, procalcitonin, C-reactive protein
Time Frame
72 hours after liberation of extracorporeal membrane oxygenation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients older than 18 years ECMO-Therapy Exclusion Criteria: patients younger than 18 years fever >38,5°C pregnancy antibiotic treatment with Vancomycine, Linezolid, Daptomycin or Tygacil on the day of liberation prior adverse events after application of Vancomycine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carsten Zeiner, MD
Phone
+49684116
Ext
21624
Email
carsten.zeiner@uks.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp M Lepper, MD
Phone
+49684116
Ext
15055
Email
philipp.lepper@uks.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp M Lepper, MD
Organizational Affiliation
Saarland University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Saarland
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation

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