Catheter-Related InfectionsIPANEMA-ECMONCT05651464
Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation
A study testing Vancomycine in people with Catheter-Related Infections, run by Universität des Saarlandes at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections
- What is being tested?
- Vancomycine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients older than 18 years
- ECMO-Therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Vancomycine
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycineDrug
Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Prophylactic antibiotic treatment | Active comparator | Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation Receives: Drug: Vancomycine |
| Control Arm: No prophylactic antibiotic treatment | No intervention | Control group - no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth of pathogens in blood culture
Detection of pathogens / blood stream infection
Measured: taken 72 hours after liberation of extracorporeal membrane oxygenation therapy
Growth of pathogens in blood culture
Detection of pathogens / blood stream infection
Measured: taken directly before removal of extracorporeal membrane oxygenation therapy
Secondary outcomes (5)
Growth of pathogens on cannula tip
Detection of growth of pathogens on cannulas
Measured: on the day of liberation, cannula tip will be send to institute of microbiology directly after liberation from ECMO
laboratory parameters
leukocytes, procalcitonin, C-reactive protein
Measured: 6.00 am on the day of liberation of extracorporeal membrane oxygenation therapy
laboratory parameters
leukocytes, procalcitonin, C-reactive protein
Measured: 24 hours after liberation of extracorporeal membrane oxygenation therapy
laboratory parameters
leukocytes, procalcitonin, C-reactive protein
Measured: 48 hours after liberation of extracorporeal membrane oxygenation therapy
laboratory parameters
leukocytes, procalcitonin, C-reactive protein
Measured: 72 hours after liberation of extracorporeal membrane oxygenation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Lepper, Universität des Saarlandes
- Investigators
- Philipp M Lepper, MD, Principal investigator, Saarland University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651464
- Sponsor's protocol ID
- PL002
- Acronym
- IPANEMA-ECMO
- Status last verified
- Dec 2022
- First submitted
- 25 Nov 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT05651464
- Acronym / sponsor ID
- IPANEMA-ECMO / PL002
- Conditions
- Catheter-Related Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Prophylactic antibiotic treatment | Active comparator | Drug: VancomycineApplication of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation |
| Control Arm: No prophylactic antibiotic treatment | No intervention | –Control group - no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients older than 18 years
- ECMO-Therapy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycineApplication of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation | Drug | Intervention: Prophylactic antibiotic treatment |
Primary outcome
Growth of pathogens in blood culture
Time frame: taken 72 hours after liberation of extracorporeal membrane oxygenation therapy
Detection of pathogens / blood stream infection
Growth of pathogens in blood culture
Time frame: taken directly before removal of extracorporeal membrane oxygenation therapy
Detection of pathogens / blood stream infection
5 secondary outcomes
Growth of pathogens on cannula tip
Time frame: on the day of liberation, cannula tip will be send to institute of microbiology directly after liberation from ECMO
laboratory parameters
Time frame: 6.00 am on the day of liberation of extracorporeal membrane oxygenation therapy
laboratory parameters
Time frame: 24 hours after liberation of extracorporeal membrane oxygenation therapy
laboratory parameters
Time frame: 48 hours after liberation of extracorporeal membrane oxygenation therapy
laboratory parameters
Time frame: 72 hours after liberation of extracorporeal membrane oxygenation therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp M Lepper, MD principal investigator
Saarland University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vancomycine in people with Catheter-Related Infections, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carsten Zeiner, MD (+49684116 ext. 21624, carsten.zeiner@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth of pathogens in blood culture (time frame: taken 72 hours after liberation of extracorporeal membrane oxygenation therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.