Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus
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ClinicalTrials.gov Identifier: NCT00730028 |
Recruitment Status :
Completed
First Posted : August 8, 2008
Results First Posted : March 17, 2016
Last Update Posted : March 17, 2016
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Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Staphylococcal Infection |
Interventions |
Drug: Trimethoprim-sulfamethoxazole Other: Placebo Drug: Clindamycin |
Enrollment | 1310 |
Participant Flow
Recruitment Details | Participants were non-immunocompromised out-patients age 6 months to 85 years with SSTIs not requiring hospital admission were recruited across 6 sites from communities with an anticipated prevalence of community-associated MRSA. Participants were enrolled between April 13, 2009 and January 13, 2015 |
Pre-assignment Details |
Arm/Group Title | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
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Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children. | Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with 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. | Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children. | Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with 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. | Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily. |
Period Title: Overall Study | |||||
Started | 264 | 260 | 266 | 263 | 257 |
Completed | 204 | 194 | 221 | 207 | 175 |
Not Completed | 60 | 66 | 45 | 56 | 82 |
Reason Not Completed | |||||
Adverse Event | 23 | 26 | 16 | 20 | 43 |
Lost to Follow-up | 13 | 26 | 22 | 26 | 25 |
Protocol Violation | 6 | 1 | 1 | 2 | 0 |
Withdrawal by Subject | 9 | 5 | 4 | 5 | 9 |
Physician Decision | 3 | 3 | 2 | 3 | 2 |
Treatment Failure | 5 | 5 | 0 | 0 | 1 |
Randomization Error | 1 | 0 | 0 | 0 | 2 |
Baseline Characteristics
Arm/Group Title | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo | Total | |
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Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children. | Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with 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. | Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children. | Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with 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. | Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily. | Total of all reporting groups | |
Overall Number of Baseline Participants | 264 | 260 | 266 | 263 | 257 | 1310 | |
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All participants enrolled in the protocol are included in the baseline analysis population.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 264 participants | 260 participants | 266 participants | 263 participants | 257 participants | 1310 participants | |
<=18 years |
81 30.7%
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74 28.5%
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101 38.0%
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91 34.6%
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89 34.6%
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436 33.3%
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Between 18 and 65 years |
181 68.6%
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184 70.8%
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164 61.7%
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169 64.3%
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166 64.6%
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864 66.0%
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>=65 years |
2 0.8%
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2 0.8%
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1 0.4%
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3 1.1%
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2 0.8%
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10 0.8%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 264 participants | 260 participants | 266 participants | 263 participants | 257 participants | 1310 participants | |
26.8 (17.2) | 27.5 (16.9) | 24.8 (17.8) | 25.6 (18.1) | 26.2 (18.7) | 27.1 (17.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 264 participants | 260 participants | 266 participants | 263 participants | 257 participants | 1310 participants | |
Female |
129 48.9%
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121 46.5%
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126 47.4%
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111 42.2%
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101 39.3%
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588 44.9%
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Male |
135 51.1%
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139 53.5%
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140 52.6%
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152 57.8%
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156 60.7%
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722 55.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 264 participants | 260 participants | 266 participants | 263 participants | 257 participants | 1310 participants |
264 | 260 | 266 | 263 | 257 | 1310 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Henry F. Chambers, MD |
Organization: | San Francisco General Hospital, UCSF |
Phone: | (415) 206 - 5437 |
EMail: | hchambers@medsfgh.ucsf.edu |
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 |
Other Study ID Numbers: |
07-0051 UCSF CA-MRSA |
First Submitted: | August 7, 2008 |
First Posted: | August 8, 2008 |
Results First Submitted: | February 18, 2016 |
Results First Posted: | March 17, 2016 |
Last Update Posted: | March 17, 2016 |