Last updated: 11/07/2018 03:11:07
Retapamulin versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus
Trial description: The purpose of this study is to provide further evidence of the clinical andbacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigodue to MRSA. Subjects aged 2 months and older will be treated with either topicalretapamulin for 5 days or oral linezolid for 10 days. The primary endpoint is the clinicalresponse at follow-up (7-9 days after the end of therapy) in subjects who have a MRSAinfection at baseline. The primary population is the per-protocol MRSA population. It isanticipated that approximately 500 subjects may be enrolled in order to obtainapproximately 105 subjects who have a baseline MRSA infection.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants achieving clinical response at follow-up who had methicillin-resistant Staphlococcus aureus (MRSA) as a baseline pathogen
Timeframe: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Secondary outcomes:
Number of participants achieving microbiological response (MR) at follow-up (FU) who had MRSA as a baseline pathogen (BP)
Timeframe: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of participants with clinical response at follow-up
Timeframe: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of participants who achieved microbiological response (MR) at follow-up (FU) who had a baseline pathogen (BP)
Timeframe: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of participants with the indicated clinical outcome at the end of therapy who had MRSA as a baseline pathogen
Timeframe: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of participants with the indicated microbiological outcome at the end of therapy who had MRSA as a baseline (BL) pathogen
Timeframe: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of participants with the indicated clinical outcome at the end of therapy
Timeframe: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of baseline pathogens with the indicated microbiological outcome at the end of therapy
Timeframe: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of participants with therapeutic response at follow-up
Timeframe: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Mean scores on the Skin Infection Rating Scale at Visits 1, 2, 3, 4, and 5
Timeframe: Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)
Mean wound size at Visits 1, 2, 3, 4, and 5
Timeframe: Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)
Interventions:
Enrollment:
410
Primary completion date:
2010-27-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Tonny Tanus, MD Nicole Scangarella-Oman, MS MaryBeth Dalessandro, BS Gang Li, PhD John Tomayko, MD John J Breton, PhD.A randomized, double-blind, comparative study to assess the safety and efficacy of topical retapamulin ointment, 1% versus oral linezolid in the treatment of secondarily-infected traumatic lesions and impetigo due to methicillin-resistant Staphylococcus aureus..Adv Skin Wound Care.2014;27(12):548-559
Medical condition
Skin Infections, Bacterial
Product
retapamulin
Collaborators
GSK
Study date(s)
April 2009 to September 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
2+ years
Accepts healthy volunteers
No
- 2 months of age or older
- diagnosis of secondarily-infected traumatic lesion (SITL) or impetigo (bullous or non-bullous)
- previous hypersensitivity to pleuromutilins or oxazolidinones
- phenylketonuria or known hypersensitivity to aspartame
Inclusion and exclusion criteria
Inclusion criteria:
- 2 months of age or older
- diagnosis of secondarily-infected traumatic lesion (SITL) or impetigo (bullous or non-bullous)
- negative urine pregnancy test (females of childbearing potential)
- total skin infection rating scale (SIRS) score of at least 8, which must include a pus/exudate score of at least 3
- subject or parent/legal guardian willing and able to comply with protocol
- written informed, dated consent, and written assent (if applicable)
Exclusion criteria:
- previous hypersensitivity to pleuromutilins or oxazolidinones
- phenylketonuria or known hypersensitivity to aspartame
- secondarily-infected animal/human bite, or puncture wound
- abscess
- chronic ulcerative lesion
- underlying skin disease (eg, eczematous dermatitis) with secondary infection
- systemic signs and symptoms of infection
- skin infection not appropriate for treatment by a topical antibiotic (eg, extensive cellulitis, furunculosis)
- subject requires surgical intervention for infection prior to study or likely will during the study
- receipt of systemic antibacterial or steroid, or application of any topical therapeutic agent directly to wound within 24 hours of entry into the study
- subject currently receiving adrenergic agents
- subject currently receiving serotonergic agents
- history of pseudomembranous colitis
- known, pre-existing myelosuppression, history of myelosuppression with linezolid use, or receiving a medication that produces bone marrow suppression
- history of siezures
- history of severe renal failure and undergoing dialysis
- serious underlying disease that could be imminently life-threatening
- pregnant, breast feeding or planning a pregnancy, or not using accepted method of contraception (females of childbearing potential or <1 year post-menopausal)
- use of another investigational drug within 30 days prior to entry into this study
- previously enrolled in this study
- fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency (for subjects <12 years of age receiving linezolid suspension)
Trial location(s)
Location
GSK Investigational Site
Bay Pines, Florida, United States, 33744
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75204
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ft. Lauderdale, Florida, United States, 33306
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Study Complete
Showing 1 - 6 of 53 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2010-27-09
Actual study completion date
2010-27-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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