Skin Diseases, BacterialNCT01619410
Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections
A study testing Linezolid and Clindamycin in people with Skin Diseases, Bacterial and Abscess, run by University of Chicago at 2 sites in United States.
Trial summary
In this pilot study, the objective is to determine the prevalence of asymptomatic carriage of S. aureus in patients with ABSSSIs and minor cutaneous abscesses after therapy with either linezolid or clindamycin at 40 days after the completion of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Diseases, Bacterial, Abscess
- What is being tested?
- Linezolid and Clindamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- having an ABSSSI or a minor cutaneous abscess treated in the ED
- age 18 years or older
- any one or more of the following co-morbidities:
- diagnosis of diabetes mellitus
- obesity with a BMI >35
- chronic kidney disease
- coronary artery disease
- peripheral vascular disease
Who cannot join
- known history of or current thrombocytopenia
- Currently taking anti-depression medication
- Current or recent hospitalization
- Known current alcohol or drug abuse
- Known or suspected hypersensitivity to any ingredient of the study drugs
- Irregular heart rate and blood pressure measurements
Show all 13Show fewer
- Fevers or low body temperature
- Known psychiatric condition
- Superficial skin infection
- Skin infection caused from an animal bite
- Recent treatment with antibacterials
- Pregnancy
- Other protocol related inclusion/exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute S. Aureus Skin and Skin Structure Infections in Patients With Comorbid Conditions: A Randomized Trial
In this pilot study, the objective is to determine the prevalence of asymptomatic carriage of S. aureus in patients with ABSSSIs and minor cutaneous abscesses after therapy with either linezolid or clindamycin at 40 days after the completion of therapy. Secondarily, the investigators will assess the efficacy of linezolid vs. clindamycin in the empiric therapy of ABSSSIs and minor cutaneous abscesses, as well as the genotypic spectrum of S. aureus isolates causing ABSSSIs or minor cutaneous abscesses and colonization in the target patient population before and after therapy. Given the results of a recent study on linezolid and vancomycin and the investigator's own experience, it is hypothesized that persistent MRSA carriage will be less common after therapy with linezolid for ABSSSIs and minor cutaneous abscesses than it is with oral clindamycin.
- Conditions
- Skin Diseases, Bacterial, Abscess
- Being tested
- Linezolid, Clindamycin
- Medical subject headings
- Skin Diseases, Bacterial, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinezolidBiological
Linezolid 600 mg every 12 hours for 7 days
ClindamycinBiological
Clindamycin 300 mg po every 6 hours for 7 days
| Study group | Role | What they receive |
|---|---|---|
| linezolid | Active comparator | Not described Receives: Biological: Linezolid |
| Clindamycin | Active comparator | Not described Receives: Biological: Clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin
Asymptomatic carriage of Staphylococcus aureus at the 40-day visit will be compared in the patients assigned to receive linezolid to the patients assigned to receive clindamycin.
Measured: 40 days after completion of treatment
Secondary outcomes (3)
Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days
The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.
Measured: 7 days after completion of treatment
Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days
The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.
Measured: 40 days after completion of treatment
The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment
The genotype of Staphylococcus aureus which is found to be the cause of the skin infection will be be compared to the genotype of Staphylococcus aureus present after treatment. Comparisons will will be made between the linezolid and clindamycin treatment groups.
Measured: 40 days after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin Diseases, BacterialStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Michael Z David, MD, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619410
- Sponsor's protocol ID
- 11-0550
- Status last verified
- Oct 2019
- First submitted
- 12 Jun 2012
- Last updated
- 8 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute S. Aureus Skin and Skin Structure Infections in Patients With Comorbid Conditions: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01619410
- Acronym / sponsor ID
- 11-0550
- Conditions
- Skin Diseases, Bacterial, Abscess
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this pilot study, the objective is to determine the prevalence of asymptomatic carriage of S. aureus in patients with ABSSSIs and minor cutaneous abscesses after therapy with either linezolid or clindamycin at 40 days after the completion of therapy. Secondarily, the investigators will assess the efficacy of linezolid vs. clindamycin in the empiric therapy of ABSSSIs and minor cutaneous abscesses, as well as the genotypic spectrum of S. aureus isolates causing ABSSSIs or minor cutaneous abscesses and colonization in the target patient population before and after therapy. Given the results of a recent study on linezolid and vancomycin and the investigator's own experience, it is hypothesized that persistent MRSA carriage will be less common after therapy with linezolid for ABSSSIs and minor cutaneous abscesses than it is with oral clindamycin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| linezolid | Active comparator | Biological: Linezolid |
| Clindamycin | Active comparator | Biological: Clindamycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- having an ABSSSI or a minor cutaneous abscess treated in the ED
- age 18 years or older
- any one or more of the following co-morbidities:
Key exclusion criteria (13 listed)
- known history of or current thrombocytopenia
- Currently taking anti-depression medication
- Current or recent hospitalization
- Known current alcohol or drug abuse
- Known or suspected hypersensitivity to any ingredient of the study 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 |
|---|---|---|
| LinezolidLinezolid 600 mg every 12 hours for 7 days | Biological | linezolid |
| ClindamycinClindamycin 300 mg po every 6 hours for 7 days | Biological | Clindamycin |
Primary outcome
Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin
Time frame: 40 days after completion of treatment
Asymptomatic carriage of Staphylococcus aureus at the 40-day visit will be compared in the patients assigned to receive linezolid to the patients assigned to receive clindamycin.
3 secondary outcomes
Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days
Time frame: 7 days after completion of treatment
Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days
Time frame: 40 days after completion of treatment
The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment
Time frame: 40 days after completion of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Z David, MD, PhD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linezolid and Clindamycin in people with Skin Diseases, Bacterial and Abscess, run by University of Chicago at 2 sites in United States.
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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 8 Nov 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin (time frame: 40 days after completion of treatment). 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 8 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.