Antibiotic ProphylaxisProphylaxisNCT05612542
Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis
An observational study of Antibiotic Prophylaxis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The objective of antibiotic prophylaxis is to prevent bacterial proliferation in order to reduce the risk of postoperative infection. Numerous recent recommendations show a benefit of a reduced duration of antibiotic prophylaxis in surgery, particularly in pediatrics. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Antibiotic Prophylaxis
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2019to 2 Mar 2020
- Phase
- Observational
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Minor patient, under 18 years of age, operated for cardiac surgery at the University Hospital of Strasbourg between January 2015 and June 2019, by sternal approach (sternotomy)
Who may be able to join
- Child less than 18 years of age,
- Operated for cardiac surgery at the University Hospital of Strasbourg between January 2015 and June 2019, by sternal approach (sternotomy),
- Child and holders of parental authority who have not expressed, after information, their objections to the reuse of his for the purpose of this research.
Who cannot join
- Child who has undergone thoracic heart surgery (thoracotomy),
- Child with an infection at the time of heart surgery,
- Child and parental authority holders who have expressed their objections to participating in this research
Trial locations and contacts
1 site in 1 country.
France1 site
Service réanimation pédiatrique médico-chirurgicale spécialisée - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: Non-inferiority Study in Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis
The objective of antibiotic prophylaxis is to prevent bacterial proliferation in order to reduce the risk of postoperative infection.
Numerous recent recommendations show a benefit of a reduced duration of antibiotic prophylaxis in surgery, particularly in pediatrics.
Read more
The study focuses on the incidence of postoperative infection by comparing antibiotic prophylaxis with 2nd generation cephalosporin (G2G) for 48 hours to a short antibiotic prophylaxis protocol limited to 24 hours.
The bacterial infections considered were those said to be care-related, according to the criteria of the French Society of Anesthesia and Intensive Care if they occurred within the 3 months postoperative interval and were not present before the surgery:
- sepsis
- superficial or deep surgical site infection (mediastinitis, sternitis, scar infection)
- catheterization infection,
- urinary tract infection or
- respiratory infection such as pneumopathy acquired under mechanical ventilation
The hypothesis is that reducing the duration of antibiotic prophylaxis does not expose patients to an increased risk of infection and limits exposure to antibiotics
- Conditions
- Antibiotic Prophylaxis
- Keywords
- Antibiotic Prophylaxis, Bacterial proliferation, Bacterial infections, Postoperative infection, Pediatric cardiac surgery
- Medical subject headings
- Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of postoperative care-related infections in cardiac surgery
Measured: 24 hours after antibiotic prophylaxis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start2 Sep 2019
- Primary completion2 Feb 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic ProphylaxisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612542
- Sponsor's protocol ID
- 7484
- Acronym
- Prophylaxis
- Status last verified
- Dec 2023
- First submitted
- 3 Nov 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study in Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis
- ClinicalTrials.gov ID
- NCT05612542
- Acronym / sponsor ID
- Prophylaxis / 7484
- Conditions
- Antibiotic Prophylaxis
- Keywords
- Antibiotic Prophylaxis, Bacterial proliferation, Bacterial infections, Postoperative infection, Pediatric cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 10 Nov 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 objective of antibiotic prophylaxis is to prevent bacterial proliferation in order to reduce the risk of postoperative infection.
Numerous recent recommendations show a benefit of a reduced duration of antibiotic prophylaxis in surgery, particularly in pediatrics.
The study focuses on the incidence of postoperative infection by comparing antibiotic prophylaxis with 2nd generation cephalosporin (G2G) for 48 hours to a short antibiotic prophylaxis protocol limited to 24 hours.
The bacterial infections considered were those said to be care-related, according to the criteria of the French Society of Anesthesia and Intensive Care if they occurred within the 3 months postoperative interval and were not present before the surgery:
- sepsis
- superficial or deep surgical site infection (mediastinitis, sternitis, scar infection)
- catheterization infection,
- urinary tract infection or
- respiratory infection such as pneumopathy acquired under mechanical ventilation
The hypothesis is that reducing the duration of antibiotic prophylaxis does not expose patients to an increased risk of infection and limits exposure to antibiotics
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Minor patient, under 18 years of age, operated for cardiac surgery at the University Hospital of Strasbourg between January 2015 and June 2019, by sternal approach (sternotomy)
Key inclusion criteria (3 listed)
- Child less than 18 years of age,
- Operated for cardiac surgery at the University Hospital of Strasbourg between January 2015 and June 2019, by sternal approach (sternotomy),
- Child and holders of parental authority who have not expressed, after information, their objections to the reuse of his for the purpose of this research.
Key exclusion criteria (3 listed)
- Child who has undergone thoracic heart surgery (thoracotomy),
- Child with an infection at the time of heart surgery,
- Child and parental authority holders who have expressed their objections to participating in this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of postoperative care-related infections in cardiac surgery
Time frame: 24 hours after antibiotic prophylaxis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Prophylaxis, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 19 Dec 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of postoperative care-related infections in cardiac surgery (time frame: 24 hours after antibiotic prophylaxis). 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 19 Dec 2023.