Burn InfectionNCT06221761
A Study on the Prophylactic Use of Antibiotics Within 72 Hours After Acute Burn Injury in Patients
A study testing not using antibiotic and using antibiotic in people with Burn Infection, run by Ruijin Hospital.
Trial summary
The goal of this clinical trial is to compare in acute burn patients. The main question it aims to answer are: what is the impact of early prophylactic use of antibiotics on prognosis Participants will be randomly divided into an antibiotic group and a non antibiotic group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Infection
- What is being tested?
- not using antibiotic and using antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 30 Jun 2025
- 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
- Signed and dated informed consent form
- Promise to comply with research procedures and cooperate with the implementation of full process research
- Age 18 and above
- Emergency hospitalization of patients in the burn department, within 24 hours after injury
- No immunodeficiency disease, no history of using immunosuppressive drugs, no antibiotics being used or infectious diseases at the time of admission
- If a woman is in the reproductive period, she should not be pregnant
Who cannot join
- Unable to obtain informed consent from subjects, family members, or authorized agents
- At the time of admission, antibiotics were being administered
- During pregnancy
- Presence of infectious diseases before admission
- Existence of immunodeficiency diseases or use of immunosuppressive drugs
- The subjects are currently undergoing other clinical studies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Randomized Controlled Study on the Prophylactic Use of Antibiotics Within 72 Hours After Acute Burn Injury in Patients
The goal of this clinical trial is to compare in acute burn patients.
The main question it aims to answer are:
- what is the impact of early prophylactic use of antibiotics on prognosis Participants will be randomly divided into an antibiotic group and a non antibiotic group.
Researchers will compare the two groups to see the 72 hour wound bacterial culture negative rate.
- Conditions
- Burn Infection
- Being tested
- not using antibiotic, using antibiotic
- Keywords
- burn, infection, antibiotic
- Medical subject headings
- Burns, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not using antibioticDrug
no antibiotic application
using antibioticDrug
antibiotic application
| Study group | Role | What they receive |
|---|---|---|
| Non antibiotic group | Experimental | Not using antibiotics within 72 hours after burns Receives: Drug: not using antibiotic |
| antibiotic group | Active comparator | Using antibiotics within 72 hours after burns Receives: Drug: using antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative rate of bacterial culture
Number of cases with negative wound culture bacteria/total number of cases
Measured: hour 72
Secondary outcomes (1)
28 day mortality rate
28 day mortality rate
Measured: 28 day after burn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Burn InfectionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly divided into two groups, one using antibiotics and the other not using antibiotics
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221761
- Sponsor's protocol ID
- 20231226
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ISBI Practice Guidelines Committee; Steering Subcommittee; Advisory Subcommittee. ISBI Practice Guidelines for Burn Care. Burns. 2016 Aug;42(5):953-1021. doi: 10.1016/j.burns.2016.05.013.
PubMed 27542292Avni T, Levcovich A, Ad-El DD, Leibovici L, Paul M. Prophylactic antibiotics for burns patients: systematic review and meta-analysis. BMJ. 2010 Feb 15;340:c241. doi: 10.1136/bmj.c241.
PubMed 20156911
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study on the Prophylactic Use of Antibiotics Within 72 Hours After Acute Burn Injury in Patients
- ClinicalTrials.gov ID
- NCT06221761
- Acronym / sponsor ID
- 20231226
- Conditions
- Burn Infection
- Keywords
- burn, infection, antibiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 Jan 2024 (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 clinical trial is to compare in acute burn patients.
The main question it aims to answer are:
- what is the impact of early prophylactic use of antibiotics on prognosis Participants will be randomly divided into an antibiotic group and a non antibiotic group.
Researchers will compare the two groups to see the 72 hour wound bacterial culture negative rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into two groups, one using antibiotics and the other not using antibiotics
| Arm | Type | Receives |
|---|---|---|
| Non antibiotic group | Experimental | Drug: not using antibioticNot using antibiotics within 72 hours after burns |
| antibiotic group | Active comparator | Drug: using antibioticUsing antibiotics within 72 hours after burns |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed and dated informed consent form
- Promise to comply with research procedures and cooperate with the implementation of full process research
- Age 18 and above
- Emergency hospitalization of patients in the burn department, within 24 hours after injury
- No immunodeficiency disease, no history of using immunosuppressive drugs, no antibiotics being used or infectious diseases at the time of admission
Key exclusion criteria (6 listed)
- Unable to obtain informed consent from subjects, family members, or authorized agents
- At the time of admission, antibiotics were being administered
- During pregnancy
- Presence of infectious diseases before admission
- Existence of immunodeficiency diseases or use of immunosuppressive drugs
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 |
|---|---|---|
| not using antibioticno antibiotic application | Drug | Non antibiotic group |
| using antibioticantibiotic application | Drug | antibiotic group |
Primary outcome
Negative rate of bacterial culture
Time frame: hour 72
Number of cases with negative wound culture bacteria/total number of cases
1 secondary outcome
28 day mortality rate
Time frame: 28 day after burn
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Results publication: PubMed 27542292ISBI Practice Guidelines Committee; Steering Subcommittee; Advisory Subcommittee. ISBI Practice Guidelines for Burn Care. Burns. 2016 Aug;42(5):953-1021. doi: 10.1016/j.burns.2016.05.013.
- Results publication: PubMed 20156911Avni T, Levcovich A, Ad-El DD, Leibovici L, Paul M. Prophylactic antibiotics for burns patients: systematic review and meta-analysis. BMJ. 2010 Feb 15;340:c241. doi: 10.1136/bmj.c241.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing not using antibiotic and using antibiotic in people with Burn Infection, run by Ruijin Hospital.
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 6 inclusion and 6 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Dou Yi (862164370045 ext. 661033, douyi815@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative rate of bacterial culture (time frame: hour 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06221761, which also lists 2 linked publications.
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 24 Jan 2024.