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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to document the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with bacterial infections, including impetigo, folliculitis, and minor soft tissue infections including secondarily infected eczema presumed to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to 98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound cultures will be collected, and then subjects will apply topical retapamulin twice daily for five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus aureus (MRSA) infection based on clinical presentation and physical exam, as well as bacteriological efficacy based on culture results. It is anticipated that approximately 75 patients will be enrolled, with expectation that approximately 50 of these patients will have MRSA infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retapamulin ointment 1% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retapamulin (Altabax) | Drug | Retapamulin ointment, applied topically twice daily for five days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit | Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain. | 6 to 8 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response at Follow up as Assessed by a Rating Scale | Clinical response was based on clinical evaluation by the investigator at the follow-up visit using a predefined scale with the following categories: (1) clinical success, (2) clinical improvement, (3) no change, (4) clinical failure, and (5) unable to determine. Patients who were designated as clinical success as defined in number 1 above were considered a true "clinical success" while all others were considered a "clinical failure." Patients were classified with an outcome of "unable to determine" if they missed their follow-up visit or refused clinical examination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adelaide A Hebert, M.D. | University of Texas Health Science Center at Houston Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Medical Center Building | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28491950 | Result | Bohaty BR, Choi S, Cai C, Hebert AA. Clinical and bacteriological efficacy of twice daily topical retapamulin ointment 1% in the management of impetigo and other uncomplicated superficial skin infections. Int J Womens Dermatol. 2015 Mar 2;1(1):13-20. doi: 10.1016/j.ijwd.2014.12.002. eCollection 2015 Feb. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Retapamulin Ointment 1% Group | Subjects with clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic were screened, and if qualified, they received topical retapamulin ointment 1% twice daily for 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Retapamulin Ointment 1% | Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit | Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain. | Participants whose wound cultures were positive for MRSA | Posted | Number | participants | 6 to 8 days after treatment |
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|
5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retapamulin Ointment 1% | Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning at Retapamulin (Altabax) application site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adelaide A Hebert | The University of Texas Health Science Center at Houston | (713) 500-8339 | Adelaide.A.Hebert@uth.tmc.edu |
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| ID | Term |
|---|---|
| D007169 | Impetigo |
| D005499 | Folliculitis |
| D004485 | Eczema |
| D003876 | Dermatitis, Atopic |
| D007239 | Infections |
| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C508887 | retapamulin |
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| 6 to 8 days after treatment |
| Microbiologic Response at Follow up as Assessed by a Rating Scale | Microbiological response was determined by the investigator at the follow-up visit using the following microbiological outcomes: (1) microbological eradication, (2) presumed microbiological eradication, (3) presumed microbiological improvement, (4) microbiological persistence, (5) presumed microbiological persistence, (6) unable to determine, (7) new pathogen, and (8) colonization. Patients who were designated microbiological eradication, presumed microbiological eradication, presumed microbiological improvement, or colonization as defined in numbers 1, 2, 3, and 8 above were considered a "microbiological success" while all others were considered "microbiological failure." | 6 to 8 days after treatment |
| Number of Participants Who Were a Therapeutic Success | Therapeutic response was determined from the clinical response and the microbiological response. Patients who qualified as both a "clinical success" and a "microbiological success" were deemed a "therapeutic success," and all others were deemed "therapeutic failures." | 6 to 8 days after treatment |
| Erythema (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | baseline |
| Erythema (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | 6 to 8 days after treatment |
| Purulence (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | baseline |
| Purulence (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | 6 to 8 days after treatment |
| Crusting (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | baseline |
| Crusting (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | 6 to 8 days after treatment |
| Tissue Edema (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | baseline |
| Tissue Edema (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | 6 to 8 days after treatment |
| Tissue Warmth (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | baseline |
| Tissue Warmth (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | 6 to 8 days after treatment |
| Pain (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | baseline |
| Pain (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | 6 to 8 days after treatment |
| Wound Size at Baseline | Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement. | baseline |
| Wound Size at Follow up | Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement. | 6 to 8 days after treatment |
| Number of Participants Reporting Any Adverse Event (AE) | AEs included burning at application site, upper respiratory infection, furuncle, cough, and a rash at a site other than the application site. See the Adverse Events section for more detailed information. | baseline to 6 to 8 days after treatment |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Clinical Response at Follow up as Assessed by a Rating Scale | Clinical response was based on clinical evaluation by the investigator at the follow-up visit using a predefined scale with the following categories: (1) clinical success, (2) clinical improvement, (3) no change, (4) clinical failure, and (5) unable to determine. Patients who were designated as clinical success as defined in number 1 above were considered a true "clinical success" while all others were considered a "clinical failure." Patients were classified with an outcome of "unable to determine" if they missed their follow-up visit or refused clinical examination. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | 6 to 8 days after treatment |
|
|
|
| Secondary | Microbiologic Response at Follow up as Assessed by a Rating Scale | Microbiological response was determined by the investigator at the follow-up visit using the following microbiological outcomes: (1) microbological eradication, (2) presumed microbiological eradication, (3) presumed microbiological improvement, (4) microbiological persistence, (5) presumed microbiological persistence, (6) unable to determine, (7) new pathogen, and (8) colonization. Patients who were designated microbiological eradication, presumed microbiological eradication, presumed microbiological improvement, or colonization as defined in numbers 1, 2, 3, and 8 above were considered a "microbiological success" while all others were considered "microbiological failure." | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | 6 to 8 days after treatment |
|
|
|
| Secondary | Number of Participants Who Were a Therapeutic Success | Therapeutic response was determined from the clinical response and the microbiological response. Patients who qualified as both a "clinical success" and a "microbiological success" were deemed a "therapeutic success," and all others were deemed "therapeutic failures." | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | 6 to 8 days after treatment |
|
|
|
| Secondary | Erythema (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | baseline |
|
|
|
| Secondary | Erythema (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | 6 to 8 days after treatment |
|
|
|
| Secondary | Purulence (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | baseline |
|
|
|
| Secondary | Purulence (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | 6 to 8 days after treatment |
|
|
|
| Secondary | Crusting (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | baseline |
|
|
|
| Secondary | Crusting (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | 6 to 8 days after treatment |
|
|
|
| Secondary | Tissue Edema (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | baseline |
|
|
|
| Secondary | Tissue Edema (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | 6 to 8 days after treatment |
|
|
|
| Secondary | Tissue Warmth (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | baseline |
|
|
|
| Secondary | Tissue Warmth (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | 6 to 8 days after treatment |
|
|
|
| Secondary | Pain (Sign and Symptom of Infection) at Baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | baseline |
|
|
|
| Secondary | Pain (Sign and Symptom of Infection) at Follow up | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Number | participants | 6 to 8 days after treatment |
|
|
|
| Secondary | Wound Size at Baseline | Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Mean | Standard Deviation | cm^2 | baseline |
|
|
|
| Secondary | Wound Size at Follow up | Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement. | All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing | Posted | Mean | Standard Deviation | cm^2 | 6 to 8 days after treatment |
|
|
|
| Secondary | Number of Participants Reporting Any Adverse Event (AE) | AEs included burning at application site, upper respiratory infection, furuncle, cough, and a rash at a site other than the application site. See the Adverse Events section for more detailed information. | All participants who received at least 1 dose of Retapamulin (Altabax) | Posted | Number | participants | baseline to 6 to 8 days after treatment |
|
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|
| 0 |
| 38 |
| 4 |
| 38 |
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
|
| Furuncle | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cough | General disorders | Non-systematic Assessment |
|
| Rash at site other than the Retapamulin (Altabax) application site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D001423 | Bacterial Infections and Mycoses |
| D013290 | Streptococcal Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006201 | Hair Diseases |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
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| 4. Clinical failure |
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| 5. Unable to determine |
|
| Title | Measurements |
|---|---|
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| 4. Microbiological persistence |
|
| 5. Presumed microbiological persistence |
|
| 6. Unable to determine |
|
| 7. New pathogen |
|
| 8. Colonization |
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