Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00676130 |
|
Recruitment Status :
Completed
First Posted : May 12, 2008
Results First Posted : August 14, 2012
Last Update Posted : August 14, 2012
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cellulitis | Drug: trimethoprim-sulfamethoxazole Drug: Cephalexin | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 153 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients |
| Study Start Date : | May 2007 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 2012 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Standard therapy
cephalexin plus placebo
|
Drug: Cephalexin
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 Other Name: Keflex |
|
Experimental: Standard plus anti-CA-MRSA
cephalexin plus trimethoprim-sulfamethoxazole
|
Drug: trimethoprim-sulfamethoxazole
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 Other Names:
Drug: Cephalexin 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 Other Name: Keflex |
- 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.
- Progression to Abscess [ Time Frame: 12 +/- 2 days, 30 days +/- 2 days ]Proportion of subjects in each arm with progression from cellulitis to abscess.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Months and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
-
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
- 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
Exclusion Criteria:
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676130
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Children's Hospital Boston | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Daniel J. Pallin, MD, MPH | Brigham and Women's Hospital |
| Responsible Party: | Daniel Jay Pallin, MD, MPH, Associate Research Director, Department of Emergency Medicine, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00676130 |
| Other Study ID Numbers: |
2007P000414 F8349839 |
| First Posted: | May 12, 2008 Key Record Dates |
| Results First Posted: | August 14, 2012 |
| Last Update Posted: | August 14, 2012 |
| Last Verified: | August 2012 |
|
Cellulitis Bactrim Trimethoprim Sulfamethoxazole MRSA Methicillin-resistant Staphylococcus aureus |
|
Cellulitis Emergencies Disease Attributes Pathologic Processes Skin Diseases, Infectious Infections Suppuration Connective Tissue Diseases Inflammation Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination Sulfamethoxazole Cephalexin |
Anti-Infective Agents, Urinary Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Bacterial Agents |