Secondarily-infected traumatic lesions (SITL), excluding those with abscesses.
Conditions
Interventions
Trade Name: Altargo,Altabax
Altargo,Altabax,Altarog
Pharmaceutical Form: Ointment
INN or Proposed INN: RETAPAMULIN
CAS Number: 224452-66-8
Current Sponsor code: RETAPAMULIN
Other descriptive name: RETAPAMULIN
Concentration unit:
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - subject is aged 2 months or older - subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion) - negative urine pregnancy test - subject has total skin infection rating scale score of at least 8, including pus/exudate score of at least 3 - subject and/or parent/legal guardian is willing and able to comply with protocol - subject or parent/legal guardian has given written informed consent or assent as applicable Are the trial subjects under 18? yes Number of subjects for this age range: 83 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 366 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: - previous hypersensitivity to pleuromutilin - secondarily-infected animal/human bite or puncture wound - subject has an abscess - chronic ulcerative lesion - underlying skin disease - systemic signs and symptoms of infection - infection not appropriately treated with topical antibiotic - infection requires surgical intervention prior to or during study - subject received systemic antibacterial or steroid, or topical therapeutic agent within 24 hours of entry into study - serious underlying disease - subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of contraception - other investigational drug within 30 days of study entry - subject previously enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was to demonstrate that topical retapamulin was clinically superior to placebo in the treatment of subjects with SITL.;Secondary Objective: The secondary objectives of this study were to evaluate the safety and bacteriological efficacy of retapamulin versus placebo in the treatment of SITL.;Primary end point(s): Clinical response at follow-up (Day 12-14)in the intent-to-treat clinical population. ;Timepoint(s) of evaluation of this end point: Time Frame: 12-14 days after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Microbiological response at follow-up (Day 12-14) Time Frame: 12-14 days after baseline •Microbiological outcome at end of therapy (Day 7-9) Time Frame: 7-9 days after baseline •Therapeutic response at follow-up (Day 12-14) Time Frame: 12-14 days after baseline •Clinical outcome at end of therapy (Day 7-9) Time Frame: 7-9 days after baseline ;Timepoint(s) of evaluation of this end point: •Microbiological response at follow-up (Day 12-14) Time Frame: 12-14 days after baseline •Microbiological outcome at end of therapy (Day 7-9) Time Frame: 7-9 days after baseline •Therapeutic response at follow-up (Day 12-14) Time Frame: 12-14 days after baseline •Clinical outcome at end of therapy (Day 7-9) Time Frame: 7-9 days after baseline | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmtihKline Research & Development Ltd.
Outcome results
None listed