Trial · NCT00852540
Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
NCT00852540, Phase 3, Completed, Stiefel, a GSK Company; results first posted 2011-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA. Trials, record NCT00852540. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00852540
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
- NCT number
- NCT00852540
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 410 participants, actual
- Lead sponsor
- Stiefel, a GSK Company
- Conditions
- Skin Infections, Bacterial
- Interventions
- Retpamulin Ointment, 1%, Linezolid
- First posted
- 2009-02-27
- Last updated
- 2017-03-27
- Results first posted
- 2011-08-26
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen | 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid | Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of "0." The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe). |
| Secondary | Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP) | 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid | MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was "clinical success (CS)/improvement," the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a "CS" such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a "CS." |
| Secondary | Number of Participants With Clinical Response at Follow-up | 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid | Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of "0." The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe). |
| Secondary | Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP) | 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid | MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was "clinical success (CS)/improvement," the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a "CS" such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a "CS." |
| Secondary | Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen | 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid | Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are "CF"/"Unable to Determine" at end of therapy are considered such at follow-up as well. |
| Secondary | Number of Participants With the Indicated Microbiological Outcome at the End of Therapy Who Had MRSA as a Baseline (BL) Pathogen | 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid | Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. "Unable to determine" was used if no determination of BL pathogen microbiological response could be made. |
| Secondary | Number of Participants With the Indicated Clinical Outcome at the End of Therapy | 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid | Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are "CF"/"Unable to Determine" at end of therapy are considered such at follow-up as well. |
| Secondary | Number of Baseline Pathogens With the Indicated Microbiological Outcome at the End of Therapy | 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid | Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. "Unable to determine" was used if no determination of BL pathogen microbiological response could be made. |
| Secondary | Number of Participants With Therapeutic Response at Follow-up | 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid | Therapeutic response is defined as the combined clinical and microbiological response. Therapeutic response iss a measure of the overall efficacy response, and a therapeutic success refers to participants who had been deemed both a "clinical success" and a "microbiological success." All other combinations (other than "clinical success" + "microbiological success") were deemed failures for therapeutic response. |
| Secondary | Mean Scores on the Skin Infection Rating Scale at Visits 1, 2, 3, 4, and 5 | Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19) | The investigator evaluated skin infections by grading the infected lesion for exudate (a fluid that leaks out of blood vessels into surrounding tissue)/pus, crusting, erythema (redness of the skin)/ inflammation (E/I), tissue warmth, tissue edema (swelling), itching, and pain, according to the Skin Infection Rating Scale. All parameters were graded on a scale of 0 (absent) to 6 (severe). The total score is calculated by summing the individual scores from the 7 parameters; the total score ranges from 0 to 42. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen | 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid | Intent-to-Treat MRSA (ITTMRSA) Population: all randomized participants who took at least one dose of study medication and who had an MRSA isolated at baseline. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP) | 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid | Intent-to-Treat MRSA (ITTMRSA) Population: all randomized participants who took at least one dose of study medication and who had an MRSA isolated at baseline. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Response at Follow-up | 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid | Intent-to-Treat Clinical (ITTC) Population: all randomized participants (par.) who took at least one dose of study medication. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables. | participants | NUMBER |
| SECONDARY | Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP) | 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid | Intent-to-Treat Bacteriology (ITTB) Population: all randomized participants who took at least one dose of study medication and who had a pathogen isolated at baseline. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen | 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid | ITTMRSA Population | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Microbiological Outcome at the End of Therapy Who Had MRSA as a Baseline (BL) Pathogen | 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid | ITTMRSA Population | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Clinical Outcome at the End of Therapy | 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid | ITTC Population. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables. | participants | NUMBER |
| SECONDARY | Number of Baseline Pathogens With the Indicated Microbiological Outcome at the End of Therapy | 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid | ITTB Population | pathogens | NUMBER |
| SECONDARY | Number of Participants With Therapeutic Response at Follow-up | 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid | ITTB Population | participants | NUMBER |
| SECONDARY | Mean Scores on the Skin Infection Rating Scale at Visits 1, 2, 3, 4, and 5 | Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19) | ITTC Population. Only participants with non-missing Skin Infection Rating Scale scores were included in this analysis. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables. | scores on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 41 | participants | ||
| Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen | Linezolid Plus Placebo Ointment | 32 | participants | ||
| Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP) | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 41 | participants | ||
| Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP) | Linezolid Plus Placebo Ointment | 32 | participants | ||
| Number of Participants With Clinical Response at Follow-up | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 161 | participants | ||
| Number of Participants With Clinical Response at Follow-up | Linezolid Plus Placebo Ointment | 112 | participants | ||
| Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP) | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 100 | participants | ||
| Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP) | Linezolid Plus Placebo Ointment | 65 | participants | ||
| Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Clinical success | 20 | participants | |
| Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen | Linezolid Plus Placebo Ointment | Clinical success | 28 | participants |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 270 | |
| Overall Study | STARTED | Linezolid Plus Placebo Ointment | 140 | |
| Overall Study | COMPLETED | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 234 | |
| Overall Study | COMPLETED | Linezolid Plus Placebo Ointment | 122 | |
| Overall Study | NOT COMPLETED | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 36 | |
| Overall Study | NOT COMPLETED | Linezolid Plus Placebo Ointment | 18 |
Source ClinicalTrials.gov
Adverse events14
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 | Diarrhea | Gastrointestinal disorders | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 8 | 267 | |
| other | Diarrhea | Gastrointestinal disorders | Linezolid Plus Placebo Ointment | 16 | 137 | |
| other | Nausea | Gastrointestinal disorders | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 6 | 267 | |
| other | Nausea | Gastrointestinal disorders | Linezolid Plus Placebo Ointment | 10 | 137 | |
| serious | Cellulitis | Infections and infestations | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 2 | 267 | |
| serious | Cellulitis | Infections and infestations | Linezolid Plus Placebo Ointment | 1 | 137 | |
| serious | Staphylococcal infection | Infections and infestations | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 1 | 267 | |
| serious | Staphylococcal infection | Infections and infestations | Linezolid Plus Placebo Ointment | 0 | 137 | |
| serious | Hypoglycaemia | Metabolism and nutrition disorders | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 0 | 267 | |
| serious | Hypoglycaemia | Metabolism and nutrition disorders | Linezolid Plus Placebo Ointment | 1 | 137 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | ||
| Total, all-cause mortality | Linezolid Plus Placebo Ointment | ||
| Total, other adverse events | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 13 | 267 |
| Total, other adverse events | Linezolid Plus Placebo Ointment | 22 | 137 |
| Total, serious adverse events | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | 3 | 267 |
| Total, serious adverse events | Linezolid Plus Placebo Ointment | 3 | 137 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25396674 | DERIVED |
Source PubMed
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo vs Linezolid Plus Placebo Ointment: Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP) | Trial comparisons |
| Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo vs Linezolid Plus Placebo Ointment: Number of Participants With Therapeutic Response at Follow-up | Trial comparisons |
Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo vs Linezolid Plus Placebo Ointment: Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen | Trial comparisons |
| Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo vs Linezolid Plus Placebo Ointment: Number of Participants With Clinical Response at Follow-up | Trial comparisons |
Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo vs Linezolid Plus Placebo Ointment: Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP) | Trial comparisons |
| Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo vs Linezolid Plus Placebo Ointment: serious adverse events | Trial comparisons |
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.
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GET https://conductscience.org/api/trials/v1/NCT00852540/results?page=2