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Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections. | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.

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

NCT00555061•GlaxoSmithKline

View on ClinicalTrials.gov

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).

Eligibility

Age

0 - 2 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (25)

GSK Investigational Site

Tuscaloosa, Alabama, United States

GSK Investigational Site

Bentonville, Arkansas, United States

GSK Investigational Site

Orange, California, United States

GSK Investigational Site

Woburn, Massachusetts, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

San José, Costa Rica

Key Dates

Start Date

September 1, 2007

Primary Completion Date

August 1, 2008

Completion Date

August 1, 2008

Last Updated

December 28, 2016

Enrollment

ACTUAL participants

Conditions

Skin Infections, Bacterial

Interventions

Retapamulin Ointment, 1%

DRUG

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Skin Infections, Bacterial

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COMPLETEDPHASE3

Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA

NCT00852540

Skin Infections, Bacterial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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