ImpetigoPhase 4NCT01126268
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
A Phase 4 study testing Retapamulin (Altabax) in people with Impetigo and Folliculitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 months to 98 years
- Conditions the study is for
- Impetigo, Folliculitis, Secondarily Infected Eczema
- What is being tested?
- Retapamulin (Altabax)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Nov 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 98 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Medical Center Building
Houston, Texas, 77030
About this study
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.
- Being tested
- Retapamulin (Altabax)
- Keywords
- Eczema, Atopic dermatitis, Infection, Impetigo, Folliculitis
- Medical subject headings
- Impetigo, Folliculitis, Eczema, Dermatitis, Atopic, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retapamulin (Altabax)Drug
Also called Altabax
Retapamulin ointment, applied topically twice daily for five days
| Study group | Role | What they receive |
|---|---|---|
| Retapamulin ointment 1% | Experimental | Not described Receives: Drug: Retapamulin (Altabax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 to 8 days after treatment
Secondary outcomes (18)
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.
Measured: 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."
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 6 to 8 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImpetigoStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Adelaide Hebert, The University of Texas Health Science Center, Houston
- Investigators
- Adelaide A Hebert, M.D., Principal investigator, University of Texas Health Science Center at Houston Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126268
- Sponsor's protocol ID
- HSC-MS-09-0650
- Status last verified
- Jan 2016
- First submitted
- 19 Apr 2010
- Last updated
- 17 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28491950
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
- ClinicalTrials.gov ID
- NCT01126268
- Acronym / sponsor ID
- HSC-MS-09-0650
- Keywords
- Eczema, Atopic dermatitis, Infection, Impetigo, Folliculitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Posted 17 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retapamulin ointment 1% | Experimental | Drug: Retapamulin (Altabax) |
Who may qualify
- Ages
- 9 months to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retapamulin (Altabax)Also: AltabaxRetapamulin ointment, applied topically twice daily for five days | Drug | Retapamulin ointment 1% |
Primary outcome
Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit
Time frame: 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.
18 secondary outcomes
Clinical Response at Follow up as Assessed by a Rating Scale
Time frame: 6 to 8 days after treatment
Microbiologic Response at Follow up as Assessed by a Rating Scale
Time frame: 6 to 8 days after treatment
Number of Participants Who Were a Therapeutic Success
Time frame: 6 to 8 days after treatment
Erythema (Sign and Symptom of Infection) at Baseline
Time frame: baseline
Erythema (Sign and Symptom of Infection) at Follow up
Time frame: 6 to 8 days after treatment
Purulence (Sign and Symptom of Infection) at Baseline
Time frame: baseline
Purulence (Sign and Symptom of Infection) at Follow up
Time frame: 6 to 8 days after treatment
Crusting (Sign and Symptom of Infection) at Baseline
Time frame: baseline
Crusting (Sign and Symptom of Infection) at Follow up
Time frame: 6 to 8 days after treatment
Tissue Edema (Sign and Symptom of Infection) at Baseline
Time frame: baseline
Tissue Edema (Sign and Symptom of Infection) at Follow up
Time frame: 6 to 8 days after treatment
Tissue Warmth (Sign and Symptom of Infection) at Baseline
Time frame: baseline
Tissue Warmth (Sign and Symptom of Infection) at Follow up
Time frame: 6 to 8 days after treatment
Pain (Sign and Symptom of Infection) at Baseline
Time frame: baseline
Pain (Sign and Symptom of Infection) at Follow up
Time frame: 6 to 8 days after treatment
Wound Size at Baseline
Time frame: baseline
Wound Size at Follow up
Time frame: 6 to 8 days after treatment
Number of Participants Reporting Any Adverse Event (AE)
Time frame: baseline to 6 to 8 days after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28491950Bohaty 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.
Related trials for Impetigo
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Not yet recruitingObservational study
Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis
Atopic Dermatitis (AD), Scabies
Not yet recruitingObservational study
Comparative Study of Adherence to Antibiotic Therapy Among Pediatric Patients: Hospital Emergency Department vs. Primary Care Center
Tonsillitis Acute, Pneumonia - Bacterial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adelaide A Hebert, M.D. principal investigator
University of Texas Health Science Center at Houston Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Retapamulin (Altabax) in people with Impetigo and Folliculitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit (time frame: 6 to 8 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01126268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.