Trial · NCT00730028
Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus
NCT00730028, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2016-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus. Trials, record NCT00730028. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00730028
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus
- NCT number
- NCT00730028
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,310 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Staphylococcal Infection
- Interventions
- Trimethoprim-sulfamethoxazole, Placebo, Clindamycin
- First posted
- 2008-08-08
- Last updated
- 2016-03-17
- Results first posted
- 2016-03-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population. | Test of cure (TOC) (7-10 days after completion of therapy) | Clinical failure is defined as the occurence of any of the following: 1. 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. 2. Occurrence of a SSTI at another site other than the site(s) under study. 3. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours. 4. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit. 5. Unplanned surgical procedure for the infection under study at any time through the TOC visit. 6. Hospitalization for treatment of active or invasive infection at any time through the TOC visit. |
| Primary | Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population. | Test of cure (TOC) (7-10 days after completion of therapy) | Clinical failure is defined as the occurence of any of the following: 1. 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. 2. Occurrence of a SSTI at another site other than the site(s) under study. 3. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours. 4. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit. 5. Unplanned surgical procedure for the infection under study at any time through the TOC visit. 6. Hospitalization for treatment of active or invasive infection at any time through the TOC visit. |
| Secondary | Number of Participants Reporting Adverse Events. | 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. |
| Secondary | Number of Participants Reporting Adverse Events That Are Treatment Limiting. | 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. |
| Secondary | Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population. | 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. |
| Secondary | Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population. | 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. |
| Secondary | Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population. | 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. |
| Secondary | Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population. | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population. | Test of cure (TOC) (7-10 days after completion of therapy) | The efficacy evaluable population was comprised of all participants who had outcomes determined at the Test of Cure (TOC) visit. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Reporting Adverse Events. | 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 who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group. | participants | NUMBER |
| SECONDARY | Number of Participants Reporting Adverse Events That Are Treatment Limiting. | 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 who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group. | participants | NUMBER |
| PRIMARY | Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population. | Test of cure (TOC) (7-10 days after completion of therapy) | The ITT population was comprised of all participants enrolled in the trial. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population. | EOT visit within 48 hours of completion of therapy | The efficacy evaluable population was comprised of all participants who had outcomes determined at the EOT visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population. | EOT visit within 48 hours of completion of therapy | All participants enrolled in the trial. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population. | OMFU visit | The efficacy evaluable population was comprised of all participants who had outcomes determined at the OMFU visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population. | OMFU visit | All participants enrolled in the trial. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population. | Cellulitis or Larger Abscess - Clindamycin | 89.5 | 95% Confidence Interval 85.2 to 93.7 | percentage of participants | |
| Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population. | Cellulitis or Larger Abscess - TMP-SMX | 88.2 | 95% Confidence Interval 83.7 to 92.7 | percentage of participants | |
| Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population. | Limited Abscess - Clindamycin | 92.9 | 95% Confidence Interval 89.3 to 96.4 | percentage of participants | |
| Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population. | Limited Abscess - TMP-SMX | 92.7 | 95% Confidence Interval 89.0 to 96.3 | percentage of participants | |
| Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population. | Limited Abscess - Placebo | 80.5 | 95% Confidence Interval 74.8 to 86.1 | percentage of participants | |
| Number of Participants Reporting Adverse Events. | Cellulitis or Larger Abscess - Clindamycin | 116 | participants | ||
| Number of Participants Reporting Adverse Events. | Cellulitis or Larger Abscess - TMP-SMX | 132 | participants | ||
| Number of Participants Reporting Adverse Events. | Limited Abscess - Clindamycin | 119 | participants | ||
| Number of Participants Reporting Adverse Events. | Limited Abscess - TMP-SMX | 94 | participants | ||
| Number of Participants Reporting Adverse Events. | Limited Abscess - Placebo | 119 | participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cellulitis or Larger Abscess - Clindamycin | 264 | |
| Overall Study | STARTED | Cellulitis or Larger Abscess - TMP-SMX | 260 | |
| Overall Study | STARTED | Limited Abscess - Clindamycin | 266 | |
| Overall Study | STARTED | Limited Abscess - TMP-SMX | 263 | |
| Overall Study | STARTED | Limited Abscess - Placebo | 257 | |
| Overall Study | COMPLETED | Cellulitis or Larger Abscess - Clindamycin | 204 | |
| Overall Study | COMPLETED | Cellulitis or Larger Abscess - TMP-SMX | 194 | |
| Overall Study | COMPLETED | Limited Abscess - Clindamycin | 221 | |
| Overall Study | COMPLETED | Limited Abscess - TMP-SMX | 207 | |
| Overall Study | COMPLETED | Limited Abscess - Placebo | 175 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events75
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abscess | Infections and infestations | Cellulitis or Larger Abscess - Clindamycin | 21 | 264 | 23 |
| other | Abscess | Infections and infestations | Cellulitis or Larger Abscess - TMP-SMX | 39 | 260 | 43 |
| other | Abscess | Infections and infestations | Limited Abscess - Clindamycin | 13 | 266 | 13 |
| other | Abscess | Infections and infestations | Limited Abscess - TMP-SMX | 29 | 263 | 30 |
| other | Abscess | Infections and infestations | Limited Abscess - Placebo | 35 | 257 | 36 |
| other | Cellulitis | Infections and infestations | Cellulitis or Larger Abscess - Clindamycin | 16 | 264 | 19 |
| other | Cellulitis | Infections and infestations | Cellulitis or Larger Abscess - TMP-SMX | 23 | 260 | 26 |
| other | Cellulitis | Infections and infestations | Limited Abscess - Clindamycin | 3 | 266 | 3 |
| other | Cellulitis | Infections and infestations | Limited Abscess - TMP-SMX | 6 | 263 | 6 |
| other | Cellulitis | Infections and infestations | Limited Abscess - Placebo | 9 | 257 | 12 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cellulitis or Larger Abscess - Clindamycin | ||
| Total, all-cause mortality | Cellulitis or Larger Abscess - TMP-SMX | ||
| Total, all-cause mortality | Limited Abscess - Clindamycin | ||
| Total, all-cause mortality | Limited Abscess - TMP-SMX | ||
| Total, all-cause mortality | Limited Abscess - Placebo | ||
| Total, other adverse events | Cellulitis or Larger Abscess - Clindamycin | 59 | 264 |
| Total, other adverse events | Cellulitis or Larger Abscess - TMP-SMX | 72 | 260 |
| Total, other adverse events | Limited Abscess - Clindamycin | 61 | 266 |
| Total, other adverse events | Limited Abscess - TMP-SMX | 52 | 263 |
| Total, other adverse events | Limited Abscess - Placebo | 60 | 257 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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