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Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
This study has been completed.
First Received: November 6, 2007   Last Updated: May 15, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00555061
  Purpose

A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).


Condition Intervention Phase
Skin Diseases, Infectious
Skin Abnormalities
Dermatoses
Impetigo
Drug: Retapamulin Ointment, 1%
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title: An Open-Label, Non-Comparative Study to Assess the Pharmacokinetics, Safety and Efficacy of Topical Retapamulin (SB-275833) Ointment, 1%, Twice Daily for Five Days in the Treatment of Uncomplicated Skin and Skin Structure Infections in Pediatric Subjects Aged 2 to 24 Months

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Plasma concentrations of retapamulin at anytime during the window of 4 to 8 hours post-dose of the first dose on Visit 2 (day 3 or day 4) overall and by age groups (=2 to =6 months, >6 to =12 months, and >12 to =24 months).

Secondary Outcome Measures:
  • Collection of safety data (adverse events and abnormal laboratory values). Clinical response at Follow-up (Day 12-16; 7-11 days after end of treatment). Bacteriological response at Follow-up. Therapeutic response at Follow-up. [ Time Frame: 5 Days ]
  • Collection of safety data (including AEs and abnormal lab values)

Estimated Enrollment: 60
Study Start Date: September 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subject Age: The subject is ≥2 months to ≤24 months of age at study entry
  • Subject Diagnosis: The subject has a diagnosis of secondarily-infected traumatic lesion (SITL), secondarily-infected dermatoses (SID), or primary impetigo (bullous or non-bullous) that is suitable for treatment with topical antibacterial therapy:

The subject has a small laceration, sutured wound or abrasion, which has a secondary bacterial infection. The infected portion of the laceration or sutured wound should not exceed 10cm in length with surrounding erythema not extending more than 2cm from the edge of the wound. Abrasions should not exceed 2% of the total body surface area with surrounding erythema not extending more than 2cm from the edge of the abrasion.

The subject has a diagnosis of inflammatory skin disease (i.e., dermatosis), such as atopic dermatitis or contact dermatitis, which has a secondary bacterial infection. The infected portion of the lesion(s) should not exceed 2% of the total body surface area.

Impetigo: The subject has a lesion or group of £10 discrete localized lesions on otherwise healthy skin, characterized by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-colored crusts surrounded by an erythematous margin.

  • Subject SIRS Score: The subject has a total SIRS score of at least 8 (Appendix 1 Skin Infection Rating Scale)
  • Protocol Compliance: The parent/legal guardian is willing to comply with the protocol
  • Informed Consent: The parent/legal guardian has given written informed, dated consent for the subject to participate in the study
  • French Subjects: In France, a subject will be eligible for inclusion in this study if either affiliated to or a beneficiary of a social security category

Exclusion criteria:

  • The subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure for composition of Retapamulin ointment, 1%)
  • The subject was considered to be premature at birth (<37 weeks gestation)
  • The subject has a secondarily-infected animal/human bite, or a puncture wound
  • The subject has an abscess
  • The subject has a chronic ulcerative lesion that is unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent
  • The subject has systemic signs and symptoms of infection (such as fever; defined as a temperature equivalent to a rectal temperature greater than 101°F or 38.3°C)
  • The subject has a bacterial skin infection which, due to area, depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic
  • The subject has more than one type of infected lesion as defined in the protocol
  • The subject requires surgical intervention for treatment of the infection prior to enrollment in the study, or is likely to require such intervention during the course of the study
  • The subject has applied any topical therapeutic agent (including glucocorticoid steroids, antibacterials or antifungals) directly to the infected wound/lesion, within 24 hours prior to study entry
  • The subject has received one or more days of treatment with a systemic antibacterial within 72 hours of study entry
  • The subject is receiving systemic corticosteroids at a dose of >0.125mg/kg per day of prednisone (or the equivalent)
  • The subject has a known, pre-existing, serious underlying disease that could be imminently life-threatening
  • The subject has participated in any study using an investigational drug during the previous 30 days prior to entering the study
  • The subject has been previously enrolled in this study or in any other study involving Retapamulin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555061

Locations
United States, Alabama
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35401
United States, Arkansas
GSK Investigational Site
Bentonville, Arkansas, United States, 72712
United States, California
GSK Investigational Site
Orange, California, United States, 92868
United States, Massachusetts
GSK Investigational Site
Woburn, Massachusetts, United States, 01801
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44106
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77090
Argentina, Buenos Aires
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425BEA
Chile, Región Metro De Santiago
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Costa Rica
GSK Investigational Site
San Jose, Costa Rica
Germany, Nordrhein-Westfalen
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Mexico
GSK Investigational Site
Mexico, Mexico, 6720
Netherlands
GSK Investigational Site
ROTTERDAM, Netherlands, 3011 TD
GSK Investigational Site
ROELOFARENDSVEEN, Netherlands, 2371 RB
GSK Investigational Site
SOERENDONK, Netherlands, 6027 RN
GSK Investigational Site
WOERDEN, Netherlands, 3443 GG
GSK Investigational Site
ALPHEN A/D RIJN, Netherlands, 2403 JK
GSK Investigational Site
LOSSER, Netherlands, 7581 BV
South Africa
GSK Investigational Site
Benoni, South Africa, 1500
GSK Investigational Site
NEWTOWN, South Africa, 2113
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: TOC106489
Study First Received: November 6, 2007
Last Updated: May 15, 2009
ClinicalTrials.gov Identifier: NCT00555061     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
infection
pharmacokinetics
SITL
SID
impetigo
pediatric
Retapamulin ointment, 1%

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Skin Diseases
Skin Abnormalities
Impetigo
Staphylococcal Skin Infections
Infection
Staphylococcal Infections
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 30, 2009