Trial · NCT00729937
Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"
NCT00729937, Phase 2, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2014-05-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA". Trials, record NCT00729937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00729937
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"
- NCT number
- NCT00729937
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 2,265 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Staphylococcal Infection
- Interventions
- Cephalexin, Clindamycin, Placebo, Trimethoprim-sulfamethoxazole
- First posted
- 2008-08-08
- Last updated
- 2015-02-18
- Results first posted
- 2014-05-28
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Days 14-21 | Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. |
| Secondary | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Days 14-21 | Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. |
| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | Day 1 to Day 3-4 | The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | Day 1 to Day 3-4 | The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | Day 1 to Day 8-10 | The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | Day 1 to Day 8-10 | The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | Day 1 to Day 14-21 | The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | Day 1 to Day 14-21 | The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Secondary | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Day 14-21 | Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary. |
| Secondary | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Day 14-21 | Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Days 14-21 | All subjects who took at least one dose of study medication were included in the intent to treat population. | participants | NUMBER |
| PRIMARY | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Days 14-21 | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | participants | NUMBER |
| SECONDARY | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | Day 1 to Day 3-4 | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | participants | NUMBER |
| SECONDARY | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | Day 1 to Day 3-4 | All subjects who took at least one dose of study medication were included in the intent to treat population. | participants | NUMBER |
| SECONDARY | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | Day 1 to Day 8-10 | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | participants | NUMBER |
| SECONDARY | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | Day 1 to Day 8-10 | All subjects who took at least one dose of study medication were included in the intent to treat population. | participants | NUMBER |
| SECONDARY | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | Day 1 to Day 14-21 | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | participants | NUMBER |
| SECONDARY | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | Day 1 to Day 14-21 | All subjects who took at least one dose of study medication were included in the intent to treat population. | participants | NUMBER |
| SECONDARY | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Day 14-21 | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | participants | NUMBER |
| SECONDARY | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Day 14-21 | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | participants | NUMBER |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group1,200
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Abscess, Placebo | Clinical Cure | 454 | participants | |
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Abscess, TMP/SMX | Clinical Cure | 507 | participants | |
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Infected Wound, TMP/SMX | Clinical Cure | 197 | participants | |
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Infected Wound, Clindamycin | Clinical Cure | 198 | participants | |
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Cellulitis, Cephalexin and TMP/SMX | Clinical Cure | 189 | participants | |
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Cellulitis, Cephalexin | Clinical Cure | 171 | participants | |
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Abscess, Placebo | Clinical Failure | 163 | participants | |
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Abscess, TMP/SMX | Clinical Failure | 123 | participants | |
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Infected Wound, TMP/SMX | Clinical Failure | 53 | participants | |
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Infected Wound, Clindamycin | Clinical Failure | 51 | participants |
1 to 10 of 1,200Source ClinicalTrials.gov
See all 1,200 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abscess, Placebo | 629 | |
| Overall Study | STARTED | Abscess, TMP/SMX | 636 | |
| Overall Study | STARTED | Infected Wound, TMP/SMX | 251 | |
| Overall Study | STARTED | Infected Wound, Clindamycin | 249 | |
| Overall Study | STARTED | Cellulitis, Cephalexin and TMP/SMX | 249 | |
| Overall Study | STARTED | Cellulitis, Cephalexin | 251 | |
| Overall Study | COMPLETED | Abscess, Placebo | 555 | |
| Overall Study | COMPLETED | Abscess, TMP/SMX | 548 | |
| Overall Study | COMPLETED | Infected Wound, TMP/SMX | 222 | |
| Overall Study | COMPLETED | Infected Wound, Clindamycin | 215 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events372
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 | Abdominal pain upper | Gastrointestinal disorders | Abscess, Placebo | 26 | 617 | 27 |
| other | Abdominal pain upper | Gastrointestinal disorders | Abscess, TMP/SMX | 38 | 630 | 40 |
| other | Abdominal pain upper | Gastrointestinal disorders | Infected Wound, TMP/SMX | 17 | 250 | 17 |
| other | Abdominal pain upper | Gastrointestinal disorders | Infected Wound, Clindamycin | 15 | 249 | 20 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cellulitis, Cephalexin and TMP/SMX | 19 | 248 | 20 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cellulitis, Cephalexin | 11 | 248 | 11 |
| other | Abscess | Infections and infestations | Abscess, Placebo | 130 | 617 | 152 |
| other | Abscess | Infections and infestations | Abscess, TMP/SMX | 88 | 630 | 100 |
| other | Abscess | Infections and infestations | Infected Wound, TMP/SMX | 20 | 250 | 26 |
| other | Abscess | Infections and infestations | Infected Wound, Clindamycin | 12 | 249 | 13 |
1 to 10 of 372Source ClinicalTrials.gov
See all 372 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abscess, Placebo | ||
| Total, all-cause mortality | Abscess, TMP/SMX | ||
| Total, all-cause mortality | Infected Wound, TMP/SMX | ||
| Total, all-cause mortality | Infected Wound, Clindamycin | ||
| Total, all-cause mortality | Cellulitis, Cephalexin and TMP/SMX | ||
| Total, all-cause mortality | Cellulitis, Cephalexin | ||
| Total, other adverse events | Abscess, Placebo | 331 | 617 |
| Total, other adverse events | Abscess, TMP/SMX | 345 | 630 |
| Total, other adverse events | Infected Wound, TMP/SMX | 138 | 250 |
| Total, other adverse events | Infected Wound, Clindamycin | 127 | 249 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers5
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00729937
GET https://conductscience.org/api/trials/v1/NCT00729937/registered?page=2