CellulitisNCT00676130
Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
A study testing trimethoprim-sulfamethoxazole and Cephalexin in people with Cellulitis, run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
The primary aim of this study is to quantify the effectiveness of Bactrim as additional therapy for the treatment of uncomplicated cellulitis in adults, by comparing: standard therapy plus Bactrim, versus standard therapy plus placebo. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Cellulitis
- What is being tested?
- trimethoprim-sulfamethoxazole and Cephalexin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2007to May 2012
- 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 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must have cellulitis as defined here:
- Definition A (preferred definition):
- Recent onset of soft tissue erythema, considered by the treating clinician to be bacterial in origin, and associated with signs of infection that include at least two of the following: pain, swelling, warmth, fever, lymphangitis, induration, or ulceration.
- Definition B (ONLY for darkly-pigmented subjects who cannot use Definition A):
- Recent onset of soft tissue color change, pain, or swelling, considered by the treating clinician to be bacterial in origin, and at least one of the following: warmth, fever, induration, or ulceration
- Clinical (non-research) attending physician agrees with treatment with cephalexin until 3 days after all symptoms gone, using our weight-based dosing
Show all 10Show fewer
- Responsible clinical attending physician comfortable with adding trimethoprim-sulfamethoxazole vs. placebo to the above
- Subject understands the study and signs written informed consent.
- Subject agrees to drink at least 1 liter of fluid per day.
- Subject will commit to all follow-up appointments
Who cannot join
- Age < 12 months or weight <15 kg
- Current skin infection has already been treated
- Allergy to sulfa drugs
- History of severe allergic reaction to penicillin (defined as anaphylactoid reaction, angioedema, bronchospasm)
- Current use of any antibiotic (other than topicals)
- Diabetes mellitus
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- Cellulitis complicated by underlying peripheral vascular disease
- Renal insufficiency, defined as patient report, clinical suspicion, or creatinine>1.3 or EGFR<60 on the last-available set of chemistry results in our computer system
- Hospital admission required
- Presence of > 1 cc of purulent discharge at any time
- Cellulitis involving an indwelling vascular, enteric, or urinary catheter
- Immunocompromise of any etiology
- Pregnancy
- Breast feeding
- Facial cellulitis (infection is above the clavicles)
- Cellulitis associated with marine or freshwater injury, or animal or human bite. (Insect bites not excluded.)
- History of glucose-6-phosphate dehydrogenase deficiency
- Taking coumadin (warfarin), methotrexate, cisapride, phenytoin (dilantin), digoxin, or dofetilide
- Known megaloblastic anemia due to folate deficiency.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients
The primary aim of this study is to quantify the effectiveness of Bactrim as additional therapy for the treatment of uncomplicated cellulitis in adults, by comparing: standard therapy plus Bactrim, versus standard therapy plus placebo.
The primary hypothesis of this study is that, in light of increasing CA-MRSA prevalence, subjects treated with standard therapy plus Bactrim will have higher cure rates than those treated with standard therapy plus placebo.
- Conditions
- Cellulitis
- Being tested
- trimethoprim-sulfamethoxazole, Cephalexin
- Keywords
- Cellulitis, Bactrim, Trimethoprim Sulfamethoxazole, MRSA, Methicillin-resistant Staphylococcus aureus
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trimethoprim-sulfamethoxazoleDrug
Also called Bactrim, Co-trimoxazole, Septra
Weight-based dosing in capsule or suspension form according to the following scale:
15-19 kg (33-42 lbs): trimethoprim-sulfamethoxazole 40/200 mg four times daily
20-24 kg (42-53 lbs): trimethoprim-sulfamethoxazole 60/300 mg four times daily
25-29 kg (53-64 lbs): trimethoprim-sulfamethoxazole 72/360 mg four times daily
29-60 kg (64-132 lbs): trimethoprim-sulfamethoxazole 80/400 mg four times daily
60 kg (132 lbs): trimethoprim-sulfamethoxazole 80/400 mg four times daily
60-80 kg (132-176 lbs): trimethoprim-sulfamethoxazole 160/800 mg three times daily
> 80 kg (176 lbs): trimethoprim-sulfamethoxazole 160/800 mg four times daily
CephalexinDrug
Also called Keflex
Weight-based dosing in capsule or suspension form according to the following scale:
15-19 kg (33-42 lbs): Cephalexin 300 mg four times daily
20-24 kg (42-53 lbs): Cephalexin 400 mg four times daily
25-29 kg (53-64 lbs): Cephalexin 500 mg four times daily
29-60 kg (64-132 lbs): Cephalexin 500 mg four times daily
60-80 kg (132-176 lbs): Cephalexin 1000 mg three times daily
> 80 kg (176 lbs): Cephalexin 1000 mg four times daily
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy | Active comparator | cephalexin plus placebo Receives: Drug: Cephalexin |
| Standard plus anti-CA-MRSA | Experimental | cephalexin plus trimethoprim-sulfamethoxazole Receives: Drug: trimethoprim-sulfamethoxazole; Drug: Cephalexin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Efficacy
Proportion of subjects in each arm with successful treatment.
Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days.
Measured: 12 +/- 2 days; 30 +/- 2 days
Secondary outcomes (1)
Progression to Abscess
Proportion of subjects in each arm with progression from cellulitis to abscess.
Measured: 12 +/- 2 days, 30 days +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startMay 2007
- Primary completionMay 2012
- Study completionMay 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CellulitisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital
- Investigators
- Daniel J. Pallin, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676130
- Sponsor's protocol ID
- 2007P000414
- Other IDs
- F8349839
- Status last verified
- Aug 2012
- First submitted
- 28 Dec 2007
- Last updated
- 14 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pallin DJ, Binder WD, Allen MB, Lederman M, Parmar S, Filbin MR, Hooper DC, Camargo CA Jr. Clinical trial: comparative effectiveness of cephalexin plus trimethoprim-sulfamethoxazole versus cephalexin alone for treatment of uncomplicated cellulitis: a randomized controlled trial. Clin Infect Dis. 2013 Jun;56(12):1754-62. doi: 10.1093/cid/cit122. Epub 2013 Mar 1.
PubMed 23457080
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients
- ClinicalTrials.gov ID
- NCT00676130
- Acronym / sponsor ID
- 2007P000414
- Conditions
- Cellulitis
- Keywords
- Cellulitis, Bactrim, Trimethoprim Sulfamethoxazole, MRSA, Methicillin-resistant Staphylococcus aureus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Posted 14 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to quantify the effectiveness of Bactrim as additional therapy for the treatment of uncomplicated cellulitis in adults, by comparing: standard therapy plus Bactrim, versus standard therapy plus placebo.
The primary hypothesis of this study is that, in light of increasing CA-MRSA prevalence, subjects treated with standard therapy plus Bactrim will have higher cure rates than those treated with standard therapy plus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard therapy | Active comparator | Drug: Cephalexincephalexin plus placebo |
| Standard plus anti-CA-MRSA | Experimental | Drug: trimethoprim-sulfamethoxazole, Drug: Cephalexincephalexin plus trimethoprim-sulfamethoxazole |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Must have cellulitis as defined here:
- Recent onset of soft tissue erythema, considered by the treating clinician to be bacterial in origin, and associated with signs of infection that include at least two of the following: pain, swelling, warmth, fever, lymphangitis, induration, or ulceration.
- Recent onset of soft tissue color change, pain, or swelling, considered by the treating clinician to be bacterial in origin, and at least one of the following: warmth, fever, induration, or ulceration
- Clinical (non-research) attending physician agrees with treatment with cephalexin until 3 days after all symptoms gone, using our weight-based dosing
- Responsible clinical attending physician comfortable with adding trimethoprim-sulfamethoxazole vs. placebo to the above
Key exclusion criteria (19 listed)
- Age < 12 months or weight <15 kg
- Current skin infection has already been treated
- Allergy to sulfa drugs
- History of severe allergic reaction to penicillin (defined as anaphylactoid reaction, angioedema, bronchospasm)
- Current use of any antibiotic (other than topicals)
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 |
|---|---|---|
| trimethoprim-sulfamethoxazoleAlso: Bactrim, Co-trimoxazole, SeptraWeight-based dosing in capsule or suspension form according to the following scale: 15-19 kg (33-42 lbs): trimethoprim-sulfamethoxazole 40/200 mg four times daily 20-24 kg (42-53 lbs): trimethoprim-sulfamethoxazole 60/300 mg four times daily 25-29 kg (53-64 lbs): trimethoprim-sulfamethoxazole 72/360 mg four times daily 29-60 kg (64-132 lbs): trimethoprim-sulfamethoxazole 80/400 mg four times daily 60 kg (132 lbs): trimethoprim-sulfamethoxazole 80/400 mg four times daily 60-80 kg (132-176 lbs): trimethoprim-sulfamethoxazole 160/800 mg three times daily > 80 kg (176 lbs): trimethoprim-sulfamethoxazole 160/800 mg four times daily | Drug | Standard plus anti-CA-MRSA |
| CephalexinAlso: KeflexWeight-based dosing in capsule or suspension form according to the following scale: 15-19 kg (33-42 lbs): Cephalexin 300 mg four times daily 20-24 kg (42-53 lbs): Cephalexin 400 mg four times daily 25-29 kg (53-64 lbs): Cephalexin 500 mg four times daily 29-60 kg (64-132 lbs): Cephalexin 500 mg four times daily 60-80 kg (132-176 lbs): Cephalexin 1000 mg three times daily > 80 kg (176 lbs): Cephalexin 1000 mg four times daily | Drug | Standard plus anti-CA-MRSA, Standard therapy |
Primary outcome
Relative Efficacy
Time frame: 12 +/- 2 days; 30 +/- 2 days
Proportion of subjects in each arm with successful treatment. Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days.
1 secondary outcome
Progression to Abscess
Time frame: 12 +/- 2 days, 30 days +/- 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23457080Pallin DJ, Binder WD, Allen MB, Lederman M, Parmar S, Filbin MR, Hooper DC, Camargo CA Jr. Clinical trial: comparative effectiveness of cephalexin plus trimethoprim-sulfamethoxazole versus cephalexin alone for treatment of uncomplicated cellulitis: a randomized controlled trial. Clin Infect Dis. 2013 Jun;56(12):1754-62. doi: 10.1093/cid/cit122. Epub 2013 Mar 1.
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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.
Daniel J. Pallin, MD, MPH principal investigator
Brigham and Women's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trimethoprim-sulfamethoxazole and Cephalexin in people with Cellulitis, run by Brigham and Women's Hospital at 3 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 10 inclusion and 19 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 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 14 Aug 2012). 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?
Relative Efficacy (time frame: 12 +/- 2 days; 30 +/- 2 days). 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 NCT00676130, which also lists 1 linked publication.
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 14 Aug 2012.