Folliculitis, Impetigo, Minor Soft Tissue Infections, Secondarily Infected Eczema
Conditions
Keywords
Eczema, Atopic dermatitis, Infection, Impetigo, Folliculitis
Brief summary
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.
Interventions
DRUGRetapamulin (Altabax)
Retapamulin ointment, applied topically twice daily for five days
Sponsors
GlaxoSmithKline
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 98 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients from 9 months of age up to 98 years of age. * Clinical diagnosis of impetigo, folliculitis, or minor soft tissue infection including secondarily infected eczema presumed to be caused by Staphylococcus aureus. * The patient, and if applicable the parent or guardian, is able to give informed consent * Females of child bearing potential have a negative urine pregnancy test. * Patient, and if applicable parent or guardian, are willing to and capable of complying with the study protocol.
Exclusion criteria
* Subject who has used a topical antibacterial medication to the area being treated within the last 48 hours. * Subject who has been enrolled in a clinical trial within the last 30 days. * Subject with signs of systemic infection (such as fever), or with evidence of abscess or cellulitis at the site to be treated. * Subject has a bacterial skin infection which would not be appropriately treated by a topical antibiotic in the opinion of the investigator * Subjects who have taken oral antibiotics within the last 7 days. * Subjects with known sensitivity to the study medication. * The subject is pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit | 6 to 8 days after treatment | Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiologic Response at Follow up as Assessed by a Rating Scale | 6 to 8 days after treatment | 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. |
| Number of Participants Who Were a Therapeutic Success | 6 to 8 days after treatment | 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. |
| Erythema (Sign and Symptom of Infection) at Baseline | baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
| Erythema (Sign and Symptom of Infection) at Follow up | 6 to 8 days after treatment | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
| Purulence (Sign and Symptom of Infection) at Baseline | baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
| Purulence (Sign and Symptom of Infection) at Follow up | 6 to 8 days after treatment | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
| Crusting (Sign and Symptom of Infection) at Baseline | baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
| Crusting (Sign and Symptom of Infection) at Follow up | 6 to 8 days after treatment | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
| Clinical Response at Follow up as Assessed by a Rating Scale | 6 to 8 days after treatment | 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. |
| Tissue Edema (Sign and Symptom of Infection) at Follow up | 6 to 8 days after treatment | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
| Tissue Warmth (Sign and Symptom of Infection) at Baseline | baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
| Tissue Warmth (Sign and Symptom of Infection) at Follow up | 6 to 8 days after treatment | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
| Pain (Sign and Symptom of Infection) at Baseline | baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
| Pain (Sign and Symptom of Infection) at Follow up | 6 to 8 days after treatment | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
| Wound Size at Baseline | 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. |
| Wound Size at Follow up | 6 to 8 days after treatment | 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. |
| Number of Participants Reporting Any Adverse Event (AE) | baseline to 6 to 8 days after treatment | 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. |
| Tissue Edema (Sign and Symptom of Infection) at Baseline | baseline | Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Retapamulin Ointment 1% Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Retapamulin Ointment 1% |
|---|---|
| Age, Categorical <=18 years | 28 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 18.5 years STANDARD_DEVIATION 25.66 |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
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.
Time frame: 6 to 8 days after treatment
Population: Participants whose wound cultures were positive for MRSA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retapamulin Ointment 1% | Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit | 5 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.
Time frame: 6 to 8 days after treatment
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Clinical Response at Follow up as Assessed by a Rating Scale | 2. Clinical improvement | 11 participants |
| Retapamulin Ointment 1% | Clinical Response at Follow up as Assessed by a Rating Scale | 3. No change | 0 participants |
| Retapamulin Ointment 1% | Clinical Response at Follow up as Assessed by a Rating Scale | 1. Clinical success | 23 participants |
| Retapamulin Ointment 1% | Clinical Response at Follow up as Assessed by a Rating Scale | 4. Clinical failure | 1 participants |
| Retapamulin Ointment 1% | Clinical Response at Follow up as Assessed by a Rating Scale | 5. Unable to determine | 0 participants |
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.
Time frame: baseline
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Crusting (Sign and Symptom of Infection) at Baseline | Absent | 2 participants |
| Retapamulin Ointment 1% | Crusting (Sign and Symptom of Infection) at Baseline | Minimal | 8 participants |
| Retapamulin Ointment 1% | Crusting (Sign and Symptom of Infection) at Baseline | Moderate | 23 participants |
| Retapamulin Ointment 1% | Crusting (Sign and Symptom of Infection) at Baseline | Severe | 2 participants |
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.
Time frame: 6 to 8 days after treatment
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Crusting (Sign and Symptom of Infection) at Follow up | Absent | 25 participants |
| Retapamulin Ointment 1% | Crusting (Sign and Symptom of Infection) at Follow up | Minimal | 9 participants |
| Retapamulin Ointment 1% | Crusting (Sign and Symptom of Infection) at Follow up | Moderate | 1 participants |
| Retapamulin Ointment 1% | Crusting (Sign and Symptom of Infection) at Follow up | Severe | 0 participants |
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.
Time frame: baseline
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Erythema (Sign and Symptom of Infection) at Baseline | Absent | 0 participants |
| Retapamulin Ointment 1% | Erythema (Sign and Symptom of Infection) at Baseline | Minimal | 10 participants |
| Retapamulin Ointment 1% | Erythema (Sign and Symptom of Infection) at Baseline | Moderate | 25 participants |
| Retapamulin Ointment 1% | Erythema (Sign and Symptom of Infection) at Baseline | Severe | 0 participants |
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.
Time frame: 6 to 8 days after treatment
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Erythema (Sign and Symptom of Infection) at Follow up | Absent | 9 participants |
| Retapamulin Ointment 1% | Erythema (Sign and Symptom of Infection) at Follow up | Minimal | 24 participants |
| Retapamulin Ointment 1% | Erythema (Sign and Symptom of Infection) at Follow up | Moderate | 2 participants |
| Retapamulin Ointment 1% | Erythema (Sign and Symptom of Infection) at Follow up | Severe | 0 participants |
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.
Time frame: 6 to 8 days after treatment
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Microbiologic Response at Follow up as Assessed by a Rating Scale | 1. Microbiological eradication | 1 participants |
| Retapamulin Ointment 1% | Microbiologic Response at Follow up as Assessed by a Rating Scale | 2. Presumed microbiological eradication | 23 participants |
| Retapamulin Ointment 1% | Microbiologic Response at Follow up as Assessed by a Rating Scale | 3. Presumed microbiological improvement | 10 participants |
| Retapamulin Ointment 1% | Microbiologic Response at Follow up as Assessed by a Rating Scale | 4. Microbiological persistence | 1 participants |
| Retapamulin Ointment 1% | Microbiologic Response at Follow up as Assessed by a Rating Scale | 5. Presumed microbiological persistence | 0 participants |
| Retapamulin Ointment 1% | Microbiologic Response at Follow up as Assessed by a Rating Scale | 6. Unable to determine | 0 participants |
| Retapamulin Ointment 1% | Microbiologic Response at Follow up as Assessed by a Rating Scale | 7. New pathogen | 0 participants |
| Retapamulin Ointment 1% | Microbiologic Response at Follow up as Assessed by a Rating Scale | 8. Colonization | 0 participants |
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.
Time frame: baseline to 6 to 8 days after treatment
Population: All participants who received at least 1 dose of Retapamulin (Altabax)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retapamulin Ointment 1% | Number of Participants Reporting Any Adverse Event (AE) | 4 participants |
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.
Time frame: 6 to 8 days after treatment
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retapamulin Ointment 1% | Number of Participants Who Were a Therapeutic Success | 23 participants |
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.
Time frame: baseline
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Pain (Sign and Symptom of Infection) at Baseline | Severe | 0 participants |
| Retapamulin Ointment 1% | Pain (Sign and Symptom of Infection) at Baseline | Absent | 8 participants |
| Retapamulin Ointment 1% | Pain (Sign and Symptom of Infection) at Baseline | Minimal | 19 participants |
| Retapamulin Ointment 1% | Pain (Sign and Symptom of Infection) at Baseline | Moderate | 8 participants |
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.
Time frame: 6 to 8 days after treatment
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Pain (Sign and Symptom of Infection) at Follow up | Absent | 26 participants |
| Retapamulin Ointment 1% | Pain (Sign and Symptom of Infection) at Follow up | Minimal | 9 participants |
| Retapamulin Ointment 1% | Pain (Sign and Symptom of Infection) at Follow up | Moderate | 0 participants |
| Retapamulin Ointment 1% | Pain (Sign and Symptom of Infection) at Follow up | Severe | 0 participants |
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.
Time frame: baseline
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Purulence (Sign and Symptom of Infection) at Baseline | Absent | 10 participants |
| Retapamulin Ointment 1% | Purulence (Sign and Symptom of Infection) at Baseline | Minimal | 14 participants |
| Retapamulin Ointment 1% | Purulence (Sign and Symptom of Infection) at Baseline | Moderate | 10 participants |
| Retapamulin Ointment 1% | Purulence (Sign and Symptom of Infection) at Baseline | Severe | 1 participants |
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.
Time frame: 6 to 8 days after treatment
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Purulence (Sign and Symptom of Infection) at Follow up | Absent | 34 participants |
| Retapamulin Ointment 1% | Purulence (Sign and Symptom of Infection) at Follow up | Minimal | 1 participants |
| Retapamulin Ointment 1% | Purulence (Sign and Symptom of Infection) at Follow up | Moderate | 0 participants |
| Retapamulin Ointment 1% | Purulence (Sign and Symptom of Infection) at Follow up | Severe | 0 participants |
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.
Time frame: baseline
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Tissue Edema (Sign and Symptom of Infection) at Baseline | Absent | 3 participants |
| Retapamulin Ointment 1% | Tissue Edema (Sign and Symptom of Infection) at Baseline | Minimal | 19 participants |
| Retapamulin Ointment 1% | Tissue Edema (Sign and Symptom of Infection) at Baseline | Moderate | 13 participants |
| Retapamulin Ointment 1% | Tissue Edema (Sign and Symptom of Infection) at Baseline | Severe | 0 participants |
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.
Time frame: 6 to 8 days after treatment
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Tissue Edema (Sign and Symptom of Infection) at Follow up | Absent | 19 participants |
| Retapamulin Ointment 1% | Tissue Edema (Sign and Symptom of Infection) at Follow up | Minimal | 16 participants |
| Retapamulin Ointment 1% | Tissue Edema (Sign and Symptom of Infection) at Follow up | Moderate | 0 participants |
| Retapamulin Ointment 1% | Tissue Edema (Sign and Symptom of Infection) at Follow up | Severe | 0 participants |
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.
Time frame: baseline
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Tissue Warmth (Sign and Symptom of Infection) at Baseline | Absent | 9 participants |
| Retapamulin Ointment 1% | Tissue Warmth (Sign and Symptom of Infection) at Baseline | Minimal | 20 participants |
| Retapamulin Ointment 1% | Tissue Warmth (Sign and Symptom of Infection) at Baseline | Moderate | 6 participants |
| Retapamulin Ointment 1% | Tissue Warmth (Sign and Symptom of Infection) at Baseline | Severe | 0 participants |
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.
Time frame: 6 to 8 days after treatment
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retapamulin Ointment 1% | Tissue Warmth (Sign and Symptom of Infection) at Follow up | Absent | 21 participants |
| Retapamulin Ointment 1% | Tissue Warmth (Sign and Symptom of Infection) at Follow up | Minimal | 14 participants |
| Retapamulin Ointment 1% | Tissue Warmth (Sign and Symptom of Infection) at Follow up | Moderate | 0 participants |
| Retapamulin Ointment 1% | Tissue Warmth (Sign and Symptom of Infection) at Follow up | Severe | 0 participants |
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.
Time frame: baseline
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retapamulin Ointment 1% | Wound Size at Baseline | 14.43 cm^2 | Standard Deviation 25.38 |
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.
Time frame: 6 to 8 days after treatment
Population: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retapamulin Ointment 1% | Wound Size at Follow up | 4.31 cm^2 | Standard Deviation 17.71 |