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Completed

NCT Number: NCT01126268

Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection

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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Key information

Conditions

Impetigo Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Folliculitis Genetic Diseases, Inborn Gram-Positive Bacterial Infections Hair Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Minor Soft Tissue Infections Secondarily Infected Eczema Skin Diseases Skin Diseases, Bacterial Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Streptococcal Infections

Age range

9 month–98 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Houston Medical Center Building

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retapamulin (Altabax)

Drug

Retapamulin ointment, applied topically twice daily for five days

Other names: Altabax

Primary outcomes

  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

    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.

Secondary outcomes

  1. Clinical Response at Follow up as Assessed by a Rating Scale

    Time frame: 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.

  2. Microbiologic Response at Follow up as Assessed by a Rating Scale

    Time frame: 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."

  3. Number of Participants Who Were a Therapeutic Success

    Time frame: 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."

  4. Erythema (Sign and Symptom of Infection) at Baseline

    Time frame: baseline

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  5. Erythema (Sign and Symptom of Infection) at Follow up

    Time frame: 6 to 8 days after treatment

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  6. Purulence (Sign and Symptom of Infection) at Baseline

    Time frame: baseline

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  7. Purulence (Sign and Symptom of Infection) at Follow up

    Time frame: 6 to 8 days after treatment

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  8. Crusting (Sign and Symptom of Infection) at Baseline

    Time frame: baseline

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  9. Crusting (Sign and Symptom of Infection) at Follow up

    Time frame: 6 to 8 days after treatment

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  10. Tissue Edema (Sign and Symptom of Infection) at Baseline

    Time frame: baseline

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  11. Tissue Edema (Sign and Symptom of Infection) at Follow up

    Time frame: 6 to 8 days after treatment

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  12. Tissue Warmth (Sign and Symptom of Infection) at Baseline

    Time frame: baseline

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  13. Tissue Warmth (Sign and Symptom of Infection) at Follow up

    Time frame: 6 to 8 days after treatment

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  14. Pain (Sign and Symptom of Infection) at Baseline

    Time frame: baseline

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  15. Pain (Sign and Symptom of Infection) at Follow up

    Time frame: 6 to 8 days after treatment

    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  16. Wound Size at Baseline

    Time frame: 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.

  17. Wound Size at Follow up

    Time frame: 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.

  18. Number of Participants Reporting Any Adverse Event (AE)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 19, 2010
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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