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

NCT05651464 | Unknown

• 1 other identifier: PL002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter-Related Infections

Outcome Measures

Primary Outcomes (2)

• Growth of pathogens in blood culture

  Detection of pathogens / blood stream infection

  taken 72 hours after liberation of extracorporeal membrane oxygenation therapy

• Growth of pathogens in blood culture

  Detection of pathogens / blood stream infection

  taken directly before removal of extracorporeal membrane oxygenation therapy

Secondary Outcomes (5)

• Growth of pathogens on cannula tip

  on the day of liberation, cannula tip will be send to institute of microbiology directly after liberation from ECMO

• laboratory parameters

  6.00 am on the day of liberation of extracorporeal membrane oxygenation therapy

• laboratory parameters

  24 hours after liberation of extracorporeal membrane oxygenation therapy

• laboratory parameters

  48 hours after liberation of extracorporeal membrane oxygenation therapy

• laboratory parameters

  72 hours after liberation of extracorporeal membrane oxygenation therapy

Study Arms (2)

Intervention: Prophylactic antibiotic treatment

ACTIVE COMPARATOR

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

Drug: Vancomycine

Control Arm: No prophylactic antibiotic treatment

NO INTERVENTION

Control group - no intervention.

Interventions

Vancomycine DRUG

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

Intervention: Prophylactic antibiotic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients older than 18 years
• ECMO-Therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

University Hospital of Saarland

Homburg, Saarland, 66421, Germany

Location

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Philipp M Lepper, MD

  Saarland University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carsten Zeiner, MD

CONTACT

+49684116; carsten.zeiner@uks.eu

Philipp M Lepper, MD

CONTACT

+49684116; philipp.lepper@uks.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 15, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)