Abscess Soft TissueNCT01498744
Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Abscess
A study testing Oral Clindamycin in people with Abscess Soft Tissue and Methicillin-resistant Staphylococcus Aureus (MRSA) Infection, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to better understand why children develop methicillin-resistant Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether antibiotics are helpful after the infection is drained in the operating room. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Abscess Soft Tissue, Methicillin-resistant Staphylococcus Aureus (MRSA) Infection, Skin Abscess
- What is being tested?
- Oral Clindamycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2013
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 1 month and 17 years of age who undergo Incision and Drainage of a skin and soft tissue abscess by a member of the Children's Memorial Hospital pediatric surgery faculty.
Who cannot join
- Children who developed their infection while hospitalized or within 2 weeks of unrelated hospital discharge will be excluded.
- Children with surgical site infections will be excluded.
- Children with inherent or acquired immunodeficiency, including but not limited to transplant patients and patients on chemotherapy or systemic corticosteroids will be excluded.
- Patients admitted to the Infectious Disease service may be excluded at the discretion of the ID attending.
- Patients who are found to have no discreet fluid collections at the time of attempted incision and drainage will be excluded.
- Patients allergic or intolerant to both bactrim and clindamycin will be excluded.
- Patients with cellulitis greater than 5 cm beyond the lateral margin of the abscess (as determined by intraoperative measurements) will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann and Robert H Lurie Children's Hospital
Chicago, Illinois, 60611
About this study
Official title: Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage
The purpose of this study is to better understand why children develop methicillin-resistant Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether antibiotics are helpful after the infection is drained in the operating room.
Read the detailed description
The emergence of community acquired methicillin-resistant Staphylococcus aureus (MRSA) as a pervasive cause of skin and soft tissue infections has increased the number of children requiring incision and drainage (I\&D) procedures and heightened concerns about the optimal treatment strategy. Data on patients with methicillin-sensitive Staphylococcus aureus (MSSA) abscesses, as well as emerging data on children with minor MRSA skin and soft tissue abscesses suggest that I\&D alone is sufficient therapy. However, given concerns about the pathogenicity of MRSA infections, many patients who require hospital admission and I\&D in the operating room receive postoperative antibiotics. The primary objective of this randomized controlled trial is to compare the effect of 5 days versus 1 day of postoperative antibiotics on the rate of treatment failure following I\&D of abscesses in children in the era of pervasive MRSA infection. Secondary outcomes to be measured include incidence of additional skin and soft tissue infections in other body sites and incidence of these infections in family members and household contacts. Prospective data will be collected from wound cultures, as well as from nasal, rectal and skin cultures sent at the time of initial I\&D to assess for MRSA carrier status. Finally, survey data will be used to assess epidemiologic risk factors.
- Conditions
- Abscess Soft Tissue, Methicillin-resistant Staphylococcus Aureus (MRSA) Infection, Skin Abscess
- Being tested
- Oral Clindamycin
- Keywords
- Skin and Soft Tissue Abscess, Methicillin-resistant Staphylococcus aureus (MRSA), Incision and Drainage, Clindamycin, Trimethoprim-sulfamethoxazole, Skin Infection
- Medical subject headings
- Infections, Surgical Wound, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ClindamycinDrug
Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
| Study group | Role | What they receive |
|---|---|---|
| 5 days postoperative antibiotic | Experimental | Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours). Receives: Drug: Oral Clindamycin |
| 1 day postoperative antibiotic | Experimental | Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours). Receives: Drug: Oral Clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.
Measured: At office visit 10-14 days post operation
Secondary outcomes (3)
Additional Skin and Soft Tissue Infections in Patient
The outcome measure was reported by responding to a yes/no
Measured: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Additional Skin or Soft Tissue Infections in Household Contacts
Measured: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Complication to Antibiotic Regime
Measured: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startFeb 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: The study was closed due to poor enrollment and lack of interest.
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 Abscess Soft TissueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Barsness, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Katherine A Barsness, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498744
- Sponsor's protocol ID
- IRB # 2010-14118
- Status last verified
- Jan 2016
- First submitted
- 20 Dec 2011
- Last updated
- 25 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage
- ClinicalTrials.gov ID
- NCT01498744
- Acronym / sponsor ID
- IRB # 2010-14118
- Conditions
- Abscess Soft Tissue, Methicillin-resistant Staphylococcus Aureus (MRSA) Infection, Skin Abscess
- Keywords
- Skin and Soft Tissue Abscess, Methicillin-resistant Staphylococcus aureus (MRSA), Incision and Drainage, Clindamycin, Trimethoprim-sulfamethoxazole, Skin Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed due to poor enrollment and lack of interest.
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Posted 25 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand why children develop methicillin-resistant Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether antibiotics are helpful after the infection is drained in the operating room.
Detailed description
The emergence of community acquired methicillin-resistant Staphylococcus aureus (MRSA) as a pervasive cause of skin and soft tissue infections has increased the number of children requiring incision and drainage (I\&D) procedures and heightened concerns about the optimal treatment strategy. Data on patients with methicillin-sensitive Staphylococcus aureus (MSSA) abscesses, as well as emerging data on children with minor MRSA skin and soft tissue abscesses suggest that I\&D alone is sufficient therapy. However, given concerns about the pathogenicity of MRSA infections, many patients who require hospital admission and I\&D in the operating room receive postoperative antibiotics. The primary objective of this randomized controlled trial is to compare the effect of 5 days versus 1 day of postoperative antibiotics on the rate of treatment failure following I\&D of abscesses in children in the era of pervasive MRSA infection. Secondary outcomes to be measured include incidence of additional skin and soft tissue infections in other body sites and incidence of these infections in family members and household contacts. Prospective data will be collected from wound cultures, as well as from nasal, rectal and skin cultures sent at the time of initial I\&D to assess for MRSA carrier status. Finally, survey data will be used to assess epidemiologic risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 days postoperative antibiotic | Experimental | Drug: Oral ClindamycinBased on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours). |
| 1 day postoperative antibiotic | Experimental | Drug: Oral ClindamycinBased on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours). |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between 1 month and 17 years of age who undergo Incision and Drainage of a skin and soft tissue abscess by a member of the Children's Memorial Hospital pediatric surgery faculty.
Key exclusion criteria (7 listed)
- Children who developed their infection while hospitalized or within 2 weeks of unrelated hospital discharge will be excluded.
- Children with surgical site infections will be excluded.
- Children with inherent or acquired immunodeficiency, including but not limited to transplant patients and patients on chemotherapy or systemic corticosteroids will be excluded.
- Patients admitted to the Infectious Disease service may be excluded at the discretion of the ID attending.
- Patients who are found to have no discreet fluid collections at the time of attempted incision and drainage will be excluded.
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 |
|---|---|---|
| Oral ClindamycinBased on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours). | Drug | 1 day postoperative antibiotic, 5 days postoperative antibiotic |
Primary outcome
Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.
Time frame: At office visit 10-14 days post operation
3 secondary outcomes
Additional Skin and Soft Tissue Infections in Patient
Time frame: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Additional Skin or Soft Tissue Infections in Household Contacts
Time frame: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Complication to Antibiotic Regime
Time frame: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Katherine A Barsness, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Clindamycin in people with Abscess Soft Tissue and Methicillin-resistant Staphylococcus Aureus (MRSA) Infection, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site 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 1 inclusion and 7 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 25 Feb 2016. 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 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 25 Feb 2016). 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?
Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation. (time frame: At office visit 10-14 days post operation). 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 25 Feb 2016.