Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.

Skin Infections, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555061
• Other study ID #: TOC106489
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2007
• Last updated: November 1, 2012
• Start date: September 2007
• Est. completion date: August 2008

Study information

• Verified date: October 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 24 Months

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Skin Diseases, Infectious
• Skin Infections, Bacterial

Intervention

Drug:
• Retapamulin Ointment, 1%
1% Ointment

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Costa Rica	GSK Investigational Site	San Jose
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Netherlands	GSK Investigational Site	Alphen A/d Rijn
Netherlands	GSK Investigational Site	Losser
Netherlands	GSK Investigational Site	Roelofarendsveen
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Woerden
South Africa	GSK Investigational Site	Benoni
South Africa	GSK Investigational Site	Newtown
United States	GSK Investigational Site	Bentonville	Arkansas
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Tuscaloosa	Alabama
United States	GSK Investigational Site	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Costa Rica,  Germany,  Netherlands,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Measurable Plasma Concentrations, by Age Group	Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL.	Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day	No
Secondary	Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age	SID = Secondarily Infected Dermatoses; SITL = Secondarily Infected Traumatic Lesions. Clinical Success is the number of participants with resolution of signs/symptoms of infection or improvement such that no additional antibiotic therapy was needed.	Follow-up, Days 12 to 16	No
Secondary	Bacteriological Success Rate at Follow-up, by Baseline Pathogen	Bacteriological success is defined as: (1) Bacteriological Eradication, elimination of the baseline pathogen via culture results; (2) Presumed Bacteriological Eradication, clinical success plus no culturable material from the wound; or (3) Colonization, new pathogen identified at Follow-up in a non-symptomatic participant who does not require additional antibiotic therapy. The number of pathogens eradicated out of the number isolated (shown as "n" in the category title) for each respective category is shown.	Follow-up, Days 12 to 16	No
Secondary	Number of Participants by Age With Therapeutic Response of Success	Therapeutic response is a measure of the overall efficacy response; a response of "therapeutic success" was based on both clinical success and bacteriological success in a given participant.	Follow-up, Days 12 to 16	No