Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.

NCT00555061 | Completed Phase 4 Results

• 1 other identifier: TOC106489
• Study Type: interventional
• Target: 60
• Locations: 9 countries
• Sites: 25

Brief 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).

Conditions

Skin Infections, Bacterial

Keywords

SID; impetigo; pharmacokinetics; Retapamulin ointment, 1%; Skin abnormalities; Dermatoses; pediatric; infection; SITL

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age

  Follow-up, Days 12 to 16

• Bacteriological Success Rate at Follow-up, by Baseline Pathogen

  Follow-up, Days 12 to 16

• Number of Participants by Age With Therapeutic Response of Success

  Follow-up, Days 12 to 16

Study Arms (1)

Arm 1

EXPERIMENTAL

Single Arm Retapamulin 1% Ointment

Drug: Retapamulin Ointment, 1%

Interventions

Retapamulin Ointment, 1% DRUG

1% Ointment

Also known as: Retapamulin Ointment, 1%

Arm 1

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (25)

GSK Investigational Site

Tuscaloosa, Alabama, 35401, United States

Location

GSK Investigational Site

Bentonville, Arkansas, 72712, United States

Location

GSK Investigational Site

Orange, California, 92868, United States

Location

GSK Investigational Site

Woburn, Massachusetts, 01801, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44106, United States

Location

GSK Investigational Site

Houston, Texas, 77090, United States

Location

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425BEA, Argentina

Location

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7580206, Chile

Location

GSK Investigational Site

San José, Costa Rica

Location

GSK Investigational Site

Nördlingen, Bavaria, 86720, Germany

Location

GSK Investigational Site

Bochum, North Rhine-Westphalia, 44791, Germany

Location

GSK Investigational Site

Erkrath, North Rhine-Westphalia, 40699, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, 47533, Germany

Location

GSK Investigational Site

México, 6720, Mexico

Location

GSK Investigational Site

Alphen aan den Rijn, 2403 JK, Netherlands

Location

GSK Investigational Site

Losser, 7581 BV, Netherlands

Location

GSK Investigational Site

Roelofarendsveen, 2371 RB, Netherlands

Location

GSK Investigational Site

Rotterdam, 3011 TD, Netherlands

Location

GSK Investigational Site

Soerendonk, 6027 RN, Netherlands

Location

GSK Investigational Site

Woerden, 3443 GG, Netherlands

Location

GSK Investigational Site

Benoni, 1501, South Africa

Location

GSK Investigational Site

Newtown, 2113, South Africa

Location

GSK Investigational Site

Taipei, 112, Taiwan

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Cellulitis; Sudden Infant Death; Impetigo; Skin Abnormalities; Skin Diseases; Infections

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death, Sudden; Death; Infant Death; Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Skin Diseases, Bacterial; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 7, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 28, 2016
• Results First Posted: April 30, 2010

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

CO (1); TW (1); US (6); NL (6); ZA (2); ME (1); CL (1); DE (5); AR (2)