secondarily-infected traumatic lesions (SITL
Conditions
Interventions
Product Name: Retapamulin
Pharmaceutical Form: Ointment
INN or Proposed INN: RETAPAMULIN
CAS Number: 224452-66-8
Concentration unit: % percent
Concentration type: equal
Concentration number: 1-
Pharma
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is aged 2 months or older. 2. The subject has a secondarily infected traumatic lesion (SITL) or impetigo (bullous or non-bullous). 3. The subject has had a negative urine pregnancy test prior to enrolment (if of childbearing potential). 4. The subject has a Total Skin Infection Rating Scale (SIRS) Score of at least 8, which must include a pus/exudate score of at least 3 (see Appendix 1). 5. The subject and/or parent/legal guardian is willing and able to comply with the study protocol. 6. The subject or parent/legal guardian, as applicable, has given written informed, dated consent; and the subject has given written assent, if applicable, to participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 116 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 256 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: 1. The subject has demonstrated a previous hypersensitivity reaction to pleuromutilins or any component of the retapamulin ointment, or to oxazolidinones. 2. The subject has phenylketonuria (PKU) or known hypersensitivity to aspartame. 3. The subject has a secondarily infected animal/human bite, or a puncture wound. 4. The subject has an abscess; defined as a localized collection of pus caused by suppuration buried in tissues. 5. The subject has a chronic ulcerative lesion that is likely to be polymicrobial and unlikely to have Staphylococcus aureus as the causative agent. 6. The subject has an underlying skin disease, such as pre-existing eczematous dermatitis, with clinical evidence of secondary infection. 7. The subject has systemic signs and symptoms of infection (e.g., a fever; defined as a rectal temperature greater than 101° F or 38.3° C). 8. The subject has a bacterial skin infection which, due to extent, depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic (e.g., extensive cellulitis, furunculosis). 9. The subject requires surgical intervention including, but not limited to, incision and drainage, for treatment of the infection prior to enrollment in the study, or is likely to require such intervention during the course of the study. This includes subjects who have infected surgical wounds from an amputation. 10. The subject has received a systemic antibacterial or steroid, or has applied any topical therapeutic agent (including glucocorticoid steroids, antibacterials and antifungals) directly to the wound, within 24 hours of entry into the study. 11. The subject is currently receiving adrenergic agents (e.g., pseudoephedrine). 12. The subject is currently receiving serotonergic agents (i.e., antidepressants). 13. The subject has a clinical history of pseudomembranous colitis. 14. The subject has known, pre-existing myelosuppression, or a history of myelosuppression with prior linezolid use, or is currently receiving a medication that produces bone marrow suppression. 15. The subject has a history of seizures. 16. The subject has a history of severe renal failure and is undergoing dialysis. 17. The subject has a serious underlying disease that could be imminently lifethreatening. 18. The subject is pregnant, breast feeding or planning a pregnancy during the study, or of childbearing potential or less than one year post-menopausal and not using an accepted method of contraception (i.e., surgical sterilization, intra-uterine contraceptive device, oral contraception plus barrier contraception, other hormone delivery systems plus barrier contraception, diaphragm or condom in combination with contraceptive cream, jelly or foam). 19. The subject has used an investigational drug within 30 days prior to entering the study. 20. The subject has been previously enrolled in this study 21. The subject has fructose intolerance, glucose-galactose malabsorption, or sucraseisomaltase insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the clinical and bacteriological efficacy of topical retapamulin ointment, 1%, versus oral linezolid, in the treatment of subjects with secondarily-infected traumatic lesions (SITL; excluding abscesses) or impetigo due to methicillin-resistant Staphylococcus aureus (MRSA).;Secondary Objective: To evaluate the safety of topical retapamulin ointment, 1%, versus linezolid, in the treatment of subjects with SITL (excluding abscesses) or impetigo due to MRSA. To evaluate the efficacy and safety of topical retapamulin ointment, 1%, versus linezolid, in the treatment of subjects with SITL (excluding abscesses) or impetigo, without regard to pathogen.;Primary end point(s): The primary endpoint is the clinical response at follow-up (7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid) in subjects with MRSA as the baseline pathogen.;Timepoint(s) of evaluation of this end point: (7 to 9 days post-therapy; ie. Day 12 to 14 for retapamulin and Day 17 to 19 for linezolid) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Microbiological response at follow-up in subjects with MRSA as the baseline pathogen • Clinical response at follow-up in all subjects • Microbiological response at follow-up in all subjects with a baseline pathogen • Clinical outcome at end of therapy (2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid) in subjects with MRSA as the baseline pathogen • Microbiological outcome at end of therapy in subjects with MRSA as the baseline pathogen • Clinical outcome at end of therapy in all subjects • Microbiological outcome at end of therapy in all subjects with a baseline pathogen • Therapeutic response (combined clinical and microbiological response) at follow-up;Timepoint(s) of evaluation of this end point: end of therapy (2 to 4 days post-therapy; ie. Day 7 to 9 for retapamulin and Day 12 to14 for linezolid) or at follow up (7 to 9 days post-therapy ie. Day 12 to 14 for retapamulin and Day 17 to 19 for linezolid) | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research and Development Ltd
Outcome results
None listed