A Phase 3 interventional study of Retpamulin Ointment, 1% and Linezolid in Skin Infections, Bacterial, sponsored by Stiefel, a GSK Company. Completed at 53 sites in United States. Open to participants aged 2 Months and older. Per ClinicalTrials.gov, last updated 2017-03-27.
Sponsored by Stiefel, a GSK Company · Phase 3, Interventional, and Treatment
The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA. Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up (7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The primary population is the per-protocol MRSA population. It is anticipated that approximately 500 subjects may be enrolled in order to obtain approximately 105 subjects who have a baseline MRSA infection.
This is a prospective, randomized, double-blind, double dummy, multicenter, comparative study in subjects 2 months of age and older with SITL (including secondarily-infected lacerations, sutured wounds and abrasions) or impetigo (bullous and non-bullous) due to MRSA. A laceration or sutured wound cannot exceed 10 cm in length with surrounding erythema not extending more than 2 cm from the edge of the lesion. Abrasions cannot exceed 100 cm2 in total area, or up to a maximum of 2% total body surface area for subjects \<18 years of age, with surrounding erythema not extending more than 2 cm from the edge of the abrasion. Subjects with impetigo can have up to 10 lesions and the infected lesion(s) must not be more than 100 cm2 in area (or up to a maximum of 2% total body surface area for subjects \<18 years of age), must not require surgical intervention and must be able to be appropriately treated with a topical antibiotic.
There are five study visits occurring over a 17-19 day period. At the baseline visit (Visit 1, day 1), subjects will be randomized to receive retapamulin (plus oral placebo) or linezolid (plus placebo ointment) in a 2:1 ratio. Retapamulin is applied twice daily for 5 days, and linezolid is dosed, depending on subject age, either twice or three times daily for 10 days. The on-therapy, end of therapy and follow-up visits are staggered due to the difference in duration of the treatment regimens. Subjects will be monitored and clinically evaluated at all postbaseline visits.
Randomization will be center-based and stratified by age (\<5 years, ≥5 to \<12 years, ≥12 years), performed using an appropriate Interactive Voice Response System (IVRS), an automated telephone system. The block size will remain confidential. Subjects are considered to have completed the study if they meet all inclusion/exclusion criteria, are considered compliant with study medication, and attend all study visits as defined by the protocol.
147 studies on the registry are indexed under Cellulitis; 14 are open to participants now.
This study's enrollment of 410 is above the median of 157 across 118 interventional studies indexed under Cellulitis.
Browse Cellulitis studies →Stiefel, a GSK Company is the lead sponsor of 55 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Retpamulin Ointment, 1%
Drug: Linezolid
Topical retapamulin (SB-275833) ointment, 1% (w/w), and placebo ointment, will be provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse-taper puncture-tip caps. Retapamulin or placebo ointment will be applied twice daily for 5 days.
Adult and adolescent (=\>12 years of age) subjects will receive one 600mg linezolid tablet (overencapsulated), or one placebo capsule, twice daily for 10 days. Pediatric subjects aged 5-11 years will receive 10mg/kg body weight of a 100mg/5mL oral linezolid suspension, or placebo suspension, twice daily for 10 days. Pediatric subjects \<5 years of age will receive 10mg/kg of a 100mg/5mL oral linezolid suspension, or placebo suspension, three times daily for 10 days.
Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen
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).
Time frame: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP)
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."
Time frame: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of Participants With Clinical Response at Follow-up
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).
Time frame: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP)
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."
Time frame: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen
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.
Time frame: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of Participants With the Indicated Microbiological Outcome at the End of Therapy Who Had MRSA as a Baseline (BL) Pathogen
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.
Time frame: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of Participants With the Indicated Clinical Outcome at the End of Therapy
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.
Time frame: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of Baseline Pathogens With the Indicated Microbiological Outcome at the End of Therapy
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.
Time frame: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of Participants With Therapeutic Response at Follow-up
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.
Time frame: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Mean Scores on the Skin Infection Rating Scale at Visits 1, 2, 3, 4, and 5
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.
Time frame: Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)
Mean Wound Size at Visits 1, 2, 3, 4, and 5
Lesion sized was measured in centimeters squared at Visits 1, 2, 3, 4, and 5.
Time frame: Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)
| Milestone | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Started | 270 | 140 |
| Completed | 234 | 122 |
| Not completed | 36 | 18 |
| Withdrew: Adverse event | 10 | 3 |
| Withdrew: Lack of efficacy | 15 | 3 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Lost to follow-up | 2 | 3 |
| Withdrew: Investigator discretion | 2 | 3 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Did not receive study drug | 3 | 3 |
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).
| participants | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen | 41 | 32 |
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."
| participants | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP) | 41 | 32 |
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).
| participants | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Number of Participants With Clinical Response at Follow-up | 161 | 112 |
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."
| participants | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP) | 100 | 65 |
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.
| participants | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Clinical success | 20 | 28 |
| Clinical improvement | 42 | 9 |
| Clinical failure | 8 | 1 |
| Unable to determine | 2 | 0 |
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.
| participants | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Eradication | 1 | 0 |
| Presumed eradication | 20 | 28 |
| Presumed improvement | 42 | 9 |
| Persistence | 4 | 1 |
| Presumed persistence | 4 | 0 |
| Unable to determine | 1 | 0 |
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.
| participants | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Clinical success | 92 | 96 |
| Clinical improvement | 155 | 34 |
| Clinical failure | 16 | 4 |
| Unable to determine | 5 | 2 |
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.
| pathogens | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Eradication | 2 | 1 |
| Presumed eradication | 63 | 70 |
| Presumed improvement | 120 | 21 |
| Persistence | 7 | 1 |
| Presumed persistence | 9 | 1 |
| Unable to determine | 1 | 0 |
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.
| participants | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Number of Participants With Therapeutic Response at Follow-up | 100 | 65 |
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.
| scores on a scale | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Pus/exudate, Visit 1, n=268, 136 | 3.6 ± 0.82 | 3.6 ± 0.8 |
| Pus/exudate, Visit 2, n=265, 135 | 1.7 ± 1.37 | 1.4 ± 1.25 |
| Pus/exudate, Visit 3, n=255, 130 | 0.6 ± 1.05 | 0.4 ± 0.74 |
| Pus/exudate, Visit 4, n=237, 125 | 0.2 ± 0.59 | 0.1 ± 0.34 |
| Pus/exudate, Visit 5, n=238, 122 | 0.1 ± 0.39 | 0.0 ± 0.29 |
| Crusting, Visit 1, n=268, 136 | 2.2 ± 1.48 | 2.1 ± 1.49 |
| Crusting, Visit 2, n=265, 135 | 1.3 ± 1.21 | 1.2 ± 1.15 |
| Crusting, Visit 3, n=255, 130 | 0.9 ± 1.08 | 0.8 ± 0.91 |
| Crusting, Visit 4, n=237, 125 | 0.6 ± 0.95 | 0.5 ± 0.83 |
| Crusting, Visit 5, n=238, 122 | 0.3 ± 0.59 | 0.3 ± 0.73 |
| E/I, Visit 1, n=268, 136 | 3.4 ± 1.09 | 3.4 ± 1.08 |
| E/I, Visit 2, n=265, 135 | 2.2 ± 1.19 | 2.2 ± 1.26 |
| E/I, Visit 3, n=255, 130 | 1.1 ± 1.15 | 1.0 ± 0.93 |
| E/I, Visit 4, n=237, 125 | 0.5 ± 0.69 | 0.5 ± 0.73 |
| E/I, Visit 5, n=238, 122 | 0.2 ± 0.54 | 0.2 ± 0.54 |
| Tissue warmth, Visit 1, n=268, 136 | 2.8 ± 1.33 | 2.6 ± 1.29 |
| Tissue warmth, Visit 2, n=265, 135 | 1.4 ± 1.22 | 1.3 ± 1.22 |
| Tissue warmth, Visit 3, n=255, 130 | 0.6 ± 0.97 | 0.4 ± 0.69 |
| Tissue warmth, Visit 4, n=237, 125 | 0.1 ± 0.41 | 0.1 ± 0.34 |
| Tissue warmth, Visit 5, n=238, 122 | 0.1 ± 0.38 | 0.0 ± 0.20 |
| Tissue edema, Visit 1, n=268, 136 | 2.8 ± 1.24 | 2.7 ± 1.30 |
| Tissue edema, Visit 2, n=265, 135 | 1.6 ± 1.23 | 1.5 ± 1.19 |
| Tissue edema, Visit 3, n=255, 130 | 0.7 ± 1.02 | 0.7 ± 0.86 |
| Tissue edema, Visit 4, n=237, 125 | 0.3 ± 0.60 | 0.2 ± 0.55 |
| Tissue edema, Visit 5, n=238, 122 | 0.1 ± 0.35 | 0.1 ± 0.36 |
| Itching, Visit 1, n=268, 136 | 1.6 ± 1.51 | 1.8 ± 1.51 |
| Itching, Visit 2, n=265, 135 | 1.0 ± 1.27 | 0.9 ± 1.11 |
| Itching, Visit 3, n=255, 130 | 0.7 ± 1.24 | 0.6 ± 1.08 |
| Itching, Visit 4, n=237, 125 | 0.3 ± 0.79 | 0.4 ± 0.76 |
| Itching, Visit 5, n=238, 122 | 0.1 ± 0.42 | 0.2 ± 0.66 |
| Pain, Visit 1, n=268, 136 | 3.2 ± 1.57 | 3.0 ± 1.65 |
| Pain, Visit 2, n=265, 135 | 1.5 ± 1.56 | 1.2 ± 1.39 |
| Pain, Visit 3, n=255, 130 | 0.6 ± 1.14 | 0.4 ± 0.96 |
| Pain, Visit 4, n=237, 125 | 0.2 ± 0.60 | 0.1 ± 0.56 |
| Pain, Visit 5, n=238, 122 | 0.1 ± 0.39 | 0.1 ± 0.45 |
| Total score, Visit 1, n=268, 136 | 19.5 ± 5.69 | 19.2 ± 5.56 |
| Total score, Visit 2, n=265, 135 | 10.7 ± 6.78 | 9.7 ± 6.32 |
| Total score, Visit 3, n=255, 130 | 5.2 ± 5.83 | 4.1 ± 4.16 |
| Total score, Visit 4, n=237, 125 | 3.6 ± 6.13 | 2.5 ± 4.13 |
| Total score, Visit 5, n=238, 122 | 2.5 ± 6.14 | 1.6 ± 3.92 |
Lesion sized was measured in centimeters squared at Visits 1, 2, 3, 4, and 5.
| centimeters squared (cm^2) | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| Visit 1, n=268, 136 | 7.942 ± 13.3124 | 5.620 ± 9.6215 |
| Visit 2, n=265, 135 | 4.963 ± 8.5492 | 4.115 ± 9.4305 |
| Visit 3, n=255, 130 | 3.270 ± 10.8663 | 1.776 ± 6.7537 |
| Visit 4, n=237, 125 | 1.556 ± 5.2201 | 0.812 ± 3.4217 |
| Visit 5, n=237, 122 | 0.741 ± 3.5977 | 0.588 ± 3.3623 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | — | 3/267 (1.1%) | 13/267 (4.9%) |
| Linezolid Plus Placebo Ointment | — | 3/137 (2.2%) | 22/137 (16.1%) |
| Event | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| CellulitisInfections and infestations | 2/267 | 1/137 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/267 | 1/137 |
| HyponatraemiaMetabolism and nutrition disorders | 0/267 | 1/137 |
| Hip fractureInjury, poisoning and procedural complications | 0/267 | 1/137 |
| Staphylococcal infectionInfections and infestations | 1/267 | 0/137 |
| Event | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment |
|---|---|---|
| DiarrheaGastrointestinal disorders | 8/267 | 16/137 |
| NauseaGastrointestinal disorders | 6/267 | 10/137 |
| Age, Continuous(Years) | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment | Total |
|---|---|---|---|
| Mean | 34.6 ± 21.37 | 33.8 ± 22.38 | 34.3 ± 21.69 |
| Sex: Female, Male(Participants) | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment | Total |
|---|---|---|---|
| Female | 108 | 49 | 157 |
| Male | 159 | 88 | 247 |
| Race/Ethnicity, Customized(participants) | Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo | Linezolid Plus Placebo Ointment | Total |
|---|---|---|---|
| African American/African Heritage | 16 | 10 | 26 |
| American Indian or Alaska Native | 5 | 0 | 5 |
| Central/South Asian Heritage | 1 | 1 | 2 |
| East Asian Heritage | 0 | 1 | 1 |
| Japanese Heritage | 5 | 2 | 7 |
| South East Asian Heritage | 3 | 0 | 3 |
| Native Hawaiian or other Pacific Islander | 5 | 1 | 6 |
| Arabic/North African Heritage | 0 | 3 | 3 |
| White/Caucasian/European | 222 | 118 | 340 |
| White - Mixed Race | 10 | 1 | 11 |
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