Infection of Skin and/or Subcutaneous TissueNCT01551719
Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation
A study testing Implemented procedure in people with Infection of Skin and/or Subcutaneous Tissue, run by Federico II University at 2 sites in Italy.
Trial summary
The general objective of the study is to assess whether the implementation of the antibiotic essay with the Breakpoint/MIC ratio and data on penetration of the antibiotic in the site of infection may improve the outcome of infections compared to using only the standard procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection of Skin and/or Subcutaneous Tissue
- What is being tested?
- Implemented procedure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesItaly
- Study dates
- Mar 2012to Mar 2013
- 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
- Written informed consent
- Bacterial infections, with microbiological isolation, in one of the following tissues: skin, soft tissue or surgical wound infections
Who cannot join
- Age < 18 years
- Inability to sign informed consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University of Naples Federico II
Naples, Naples, I-80131
University of Naples Federico II
Naples, I-80131
About this study
The general objective of the study is to assess whether the implementation of the antibiotic essay with the Breakpoint/MIC ratio and data on penetration of the antibiotic in the site of infection may improve the outcome of infections compared to using only the standard procedures.
- Being tested
- Implemented procedure
- Keywords
- Bacterial infection of skin or soft tissues
- Medical subject headings
- Cellulitis, Skin Diseases, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implemented procedureBehavioural
Also called MIC/Breakpoint ratio and tissue penetration for available antibiotics e.g., - Semisynthetic Penicillins, - Cephalosporins, - Linezolid
Prescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection.
| Study group | Role | What they receive |
|---|---|---|
| Standard Procedure (phase I) | No intervention | Antibiotic prescription following in vitro sensitivity test according to each surgeon's will. |
| Implemented procedure | Experimental | Prescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection, according to each surgeon's will. Receives: Behavioral: Implemented procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete recovery rate from infection
Complete resolution of fever, leukocytosis, and any local signs of infection
Measured: At the end of treatment (an expected average of 10 days)
Secondary outcomes (3)
Time to recovery from infection.
Days to recovery completely from infection.
Measured: At the end of treatment (an expected average of 10 days)
Partial response
Improvement of fever, leukocytosis, and any local signs of infection
Measured: At the end of treatment (an expected average of 10 days)
Rate of non responders
Treatment failure, relapse and death. Failure is defined as no improvement or even worsening of the signs and symptoms of infection.
Relapse is defined as the resumption of infection with the same organism at any body part within one month after completion of treatment
Measured: At the end of treatment (an expected average of 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection of Skin and/or Subcutaneous TissueStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Guglielmo Borgia, Federico II University
- Investigators
- Guglielmo Borgia, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551719
- Sponsor's protocol ID
- 52/11
- Status last verified
- Dec 2012
- First submitted
- 29 Feb 2012
- Last updated
- 31 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation
- ClinicalTrials.gov ID
- NCT01551719
- Acronym / sponsor ID
- 52/11
- Keywords
- Bacterial infection of skin or soft tissues
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 13 Mar 2012 (estimated)
- 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 general objective of the study is to assess whether the implementation of the antibiotic essay with the Breakpoint/MIC ratio and data on penetration of the antibiotic in the site of infection may improve the outcome of infections compared to using only the standard procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Procedure (phase I) | No intervention | –Antibiotic prescription following in vitro sensitivity test according to each surgeon's will. |
| Implemented procedure | Experimental | Behavioral: Implemented procedurePrescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection, according to each surgeon's will. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent
- Bacterial infections, with microbiological isolation, in one of the following tissues: skin, soft tissue or surgical wound infections
Key exclusion criteria (2 listed)
- Age < 18 years
- Inability to sign informed consent
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 |
|---|---|---|
| Implemented procedureAlso: MIC/Breakpoint ratio and tissue penetration for available antibiotics e.g., - Semisynthetic Penicillins, - Cephalosporins, - LinezolidPrescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection. | Behavioural | Implemented procedure |
Primary outcome
Complete recovery rate from infection
Time frame: At the end of treatment (an expected average of 10 days)
Complete resolution of fever, leukocytosis, and any local signs of infection
3 secondary outcomes
Time to recovery from infection.
Time frame: At the end of treatment (an expected average of 10 days)
Partial response
Time frame: At the end of treatment (an expected average of 10 days)
Rate of non responders
Time frame: At the end of treatment (an expected average of 10 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2012.
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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.
Guglielmo Borgia principal investigator
Federico II University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implemented procedure in people with Infection of Skin and/or Subcutaneous Tissue, run by Federico II University at 2 sites in Italy.
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 2 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: withdrawn, as of the sponsor's last update on 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 was withdrawn before enrolling participants, so there are no results.
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?
Complete recovery rate from infection (time frame: At the end of treatment (an expected average of 10 days)). 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 31 Dec 2012.