Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus
![]() |
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: NCT00730028 |
Recruitment Status
:
Completed
First Posted
: August 8, 2008
Results First Posted
: March 17, 2016
Last Update Posted
: March 17, 2016
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Staphylococcal Infection | Drug: Trimethoprim-sulfamethoxazole Other: Placebo Drug: Clindamycin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1310 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Double-Blind Trial of Clindamycin, Trimethoprim-Sulfamethoxazole, or Placebo for Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | February 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Limited Abscess
Limited abscess with or without cellulitis less than or equal to 5 cm in diameter will be randomized to receive a 10-day course a) TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children; or b) CLINDA 300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children; or c) placebo two capsules three times daily.
|
Drug: Trimethoprim-sulfamethoxazole
Trimethoprim-sulfamethoxazole (TMP-SMX) will be administered orally at a dose of 160 mg TMP and 800 mg SMX (as 2 single strength over encapsulated tablets) twice daily (adult or child > 40 kg dose) or 8-10 mg TMP, 40-50 mg SMX per kg daily, divided into 2 daily doses (child < 40 kg dose). Study drug will be administered for 10 days.
Other: Placebo
Placebo capsules will be identical in appearance to the CLINDA and TMP-SMX. Administered 3 times daily for 10 days.
Drug: Clindamycin
CLINDA (adult dose of 300 mg three times daily; pediatric dose of 25-30 mg/kg/day divided three times daily up to a maximum dose of 900 mg/day). Study drug will be administered for 10 days.
|
Experimental: Cellulitis or Larger Abscess
Subjects with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection will be randomized to receive a 10-day course a) TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children; or b) CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Drug: Trimethoprim-sulfamethoxazole
Trimethoprim-sulfamethoxazole (TMP-SMX) will be administered orally at a dose of 160 mg TMP and 800 mg SMX (as 2 single strength over encapsulated tablets) twice daily (adult or child > 40 kg dose) or 8-10 mg TMP, 40-50 mg SMX per kg daily, divided into 2 daily doses (child < 40 kg dose). Study drug will be administered for 10 days.
Drug: Clindamycin
CLINDA (adult dose of 300 mg three times daily; pediatric dose of 25-30 mg/kg/day divided three times daily up to a maximum dose of 900 mg/day). Study drug will be administered for 10 days.
|
- Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population. [ Time Frame: Test of cure (TOC) (7-10 days after completion of therapy) ]
Clinical failure is defined as the occurence of any of the following:
- Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.
- Occurrence of a SSTI at another site other than the site(s) under study.
- Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.
- Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.
- Unplanned surgical procedure for the infection under study at any time through the TOC visit.
- Hospitalization for treatment of active or invasive infection at any time through the TOC visit.
- Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population. [ Time Frame: Test of cure (TOC) (7-10 days after completion of therapy) ]
Clinical failure is defined as the occurence of any of the following:
- Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.
- Occurrence of a SSTI at another site other than the site(s) under study.
- Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.
- Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.
- Unplanned surgical procedure for the infection under study at any time through the TOC visit.
- Hospitalization for treatment of active or invasive infection at any time through the TOC visit.
- Number of Participants Reporting Adverse Events. [ Time Frame: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU) ]Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.
- Number of Participants Reporting Adverse Events That Are Treatment Limiting. [ Time Frame: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU) ]Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.
- Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population. [ Time Frame: EOT visit within 48 hours of completion of therapy ]Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
- Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population. [ Time Frame: EOT visit within 48 hours of completion of therapy ]Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
- Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population. [ Time Frame: OMFU visit ]Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.
- Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population. [ Time Frame: OMFU visit ]Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.

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: | 6 Months to 85 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 6 months to 85 years.
- Able to complete the informed consent process or, if a minor, a parent or guardian who is able to complete the informed consent process; an assent form also will be completed for children age 7 and older.
- Willing and able to complete the study protocol, study-related activities, and visits.
-
Diagnosis of uncomplicated skin and soft tissue infection (uSSTI), either cellulitis (defined as an inflammation of skin and associated skin structures) or abscess (defined as a circumscribed collection of pus), evidenced by at least 2 of the following localized signs or symptoms on the skin for at least 24 hours:
- Erythema
- Swelling or induration
- Local warmth
- Purulent drainage
- Tenderness to palpation or pain
- Able to take oral antibiotic therapy, either in pill or suspension form.
Exclusion Criteria:
- Hospital in-patient.
- Hospitalization within the prior 14 days.
- Residence in a long-term skilled nursing facility.
- Requirement for hospitalization for skin infection or other condition.
- Previous enrollment in this protocol.
- Participation in another clinical trial within the previous 30 days.
-
Superficial skin infection only, including:
- Impetigo
- Ecthyma
- Folliculitis
- Infections that have a high cure rate after surgical incision alone (such as isolated furunculosis) or after topical or local measures
- Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete study requirements.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with the adherence or subject compliance with study requirements.
- Systolic blood pressure > 180 mm Hg.
-
Systolic blood pressure (SBP) less than an age-specific critical value:
- Age 6 - 11 months: < 70 mm Hg
- Age 1 to 8 years: < 80 mm Hg
- Age 9 to 17 years: < 90 mm Hg
- Age greater than or equal to 18 years: < 90 mm Hg
- Heart rate less than 45 beats per minute (BPM).
-
Heart rate greater than an age-specific critical value:
- Age 6 - 11 months: > 140 BPM
- Age 1 to 8 years: > 120 BPM
- Age 9 to 17 years: > 120 BPM
- Age greater than or equal to 18 years: > 120 BPM.
- Oral temperature (or equivalent rectal, tympanic membrane, axillary) less than 35.5 degrees Celsius (95.9 degrees Fahrenheit).
-
Oral temperature (or equivalent rectal, tympanic membrane, axillary) greater than age-specific critical value:
- Age 6 - 11 months: > 38.0 degrees Celsius (100.4 degrees Fahrenheit)
- Age 1 to 8 years: > 38.5 degrees Celsius (101.3 degrees Fahrenheit)
- Age 9 to 17 years: > 38.5 degrees Celsius (101.3 degrees Fahrenheit)
- Age greater than or equal to 18 years: > 38.5 degrees Celsius (101.3 degrees Fahrenheit).
- Documented human or witnessed animal bite in the past 30 days at the site of infection.
- Systemic antibacterial therapy with antistaphylococcal activity within the prior 14 days.
- The following concomitant medications: warfarin, phenytoin, methotrexate, rosiglitazone or sulfonylureas and systemically administered antibacterial agents with activity against staphylococci.
- Diagnosed or suspected disseminated or severe Staphylococcus aureus or group A streptococcal (GAS) infection, including lymphangitic spread of skin infection, septicemia, bacteremia, pneumonia, endocarditis, osteomyelitis, septic arthritis, gangrene, necrotizing fasciitis, myositis, or other serious infections.
-
Infection at an anatomical skin site requiring specialized management or specialized antimicrobial therapy, including:
- Periauricular or orbital infection
- Perirectal infection
- Suspected deep space infection of the hand or foot
- Genital infection
- Mastitis
- Bursitis
- Radiographic evidence or suspicion of gas in the tissue or foreign body infection (note: radiography is not required for screening and can be performed at the discretion of the treating physician).
- Gastrointestinal symptoms such as nausea, vomiting, or diarrhea of a severity that would preclude consumption of oral antibiotics.
- Hypersensitivity or history of allergic reaction to study drug.
- History of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Third trimester pregnancy: pregnant women must have gestational age estimated by an objective means, e.g. ultrasound, fundal height, and women who are within 4 weeks of the third trimester of pregnancy, defined as week 27 of pregnancy, are not eligible.
- Currently breast feeding.
- Severe or morbid obesity with a body mass index (BMI) >40 kg/m^2.
-
Complicated skin or soft tissue infection, such as:
- Catheter or catheter site infection within 30 days of placement
- Surgical site infection
- Known or suspected prosthetic device infection
- Suspected Gram-negative or anaerobic pathogen
- Unusual exposure history (e.g., underwater injury, fish-tank exposure, heavy soil exposure, etc)
- Infection at the site of an area of underlying skin disease such as chronic eczema, psoriasis, atopic dermatitis, or chronic venous stasis
-
History of underlying immunocompromising condition or immunodeficiency, for example:
- Diabetes mellitus
- Chronic renal failure, creatinine clearance <30 ml/min
- Renal dialysis within the past 180 days
- Human immunodeficiency virus (HIV)-positive with either cluster of differentiation (CD)4 count <200 or <4 percent CD4 in the past 180 days or HIV-positive and no documented CD4 count in the past 4 months
- Organ or bone marrow transplantation (ever), immunosuppressive therapy within the past 180 days, severe liver disease
- Other serious underlying disease, as determined by the treating physician or the investigator

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): NCT00730028
United States, California | |
San Francisco General Hospital - Infectious Diseases | |
San Francisco, California, United States, 94110-3518 | |
Harbor UCLA Medical Center - Medicine - Infectious Diseases | |
Torrance, California, United States, 90502-2006 | |
United States, Georgia | |
Morehouse School of Medicine - Morehouse Medical Associates - Atlanta | |
Atlanta, Georgia, United States, 30303-2544 | |
United States, Illinois | |
The University of Chicago - Comer Children's Hospital - Infectious Diseases | |
Chicago, Illinois, United States, 60637-1425 | |
United States, Missouri | |
Washington University School of Medicine in St. Louis - Infectious Diseases | |
Saint Louis, Missouri, United States, 63110-1010 | |
United States, Tennessee | |
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | |
Nashville, Tennessee, United States, 37232-2573 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00730028 History of Changes |
Other Study ID Numbers: |
07-0051 UCSF CA-MRSA |
First Posted: | August 8, 2008 Key Record Dates |
Results First Posted: | March 17, 2016 |
Last Update Posted: | March 17, 2016 |
Last Verified: | April 2015 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Methicillin-resistant Staphylococcus aureus (MRSA), cellulitis, abscess, children, elderly |
Additional relevant MeSH terms:
Infection Communicable Diseases Staphylococcal Infections Soft Tissue Infections Gram-Positive Bacterial Infections Bacterial Infections Clindamycin Clindamycin palmitate Clindamycin phosphate Methicillin Trimethoprim, Sulfamethoxazole Drug Combination Trimethoprim Sulfamethoxazole |
Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors |