None listed
Conditions
Interventions
Group 1 Type of group
Twice a day the topical retapamulin ointment for 5 days. The ointment will be applied on infected lesions in approximate doses of 10 mg per cm2.
Group name:Group 2 Type of group
Twice a day the topical placebo ointment for 5 days. The placebo ointment will be applied on infected lesions in approximate doses of 10 mg per cm2.
Sponsors
GlaxoSmithKline,
Eligibility
Sex/Gender
All
Age
No minimum to 100 Years
Inclusion criteria
Inclusion criteria: • The subject is 2 months old or older. • Attention: this study does not require a pre-established number of pediatric patients. Therefore, the minimum age for inclusion in this study will be 2 months or any age greater than 2 months, as stipulated by the Institutional Review Committee, the Ethics Committee or the GSK National Medical Department. • The subject has a secondaryly infected traumatic injury, be it a laceration, sutured wound or small abrasion. The infected sector of laceration or sutured wound should not exceed 10 cm. in length and the surrounding erythema should not extend more than 2 cm. from the edge of the lesion. The infected sector of the abrasion should not exceed 100 cm2 of total area or up to a maximum of 2% of the total body surface in subjects <18 years of age and the surrounding erythema should not extend more than 2 cm. from the edge of abrasion. • The patient has had a negative pregnancy test before enrollment (if she is of childbearing age). • The subject has a Total Score on the Skin Infection Score Score of at least 8, which should include a pus / exudate score of at least 1 (Appendix 1). • The subject and / or parents or legal representative accept and are able to comply with the study protocol. • The subject or his parents or his legal representative, as appropriate, has given written consent and dated the consent; and the subject has given written consent, if applicable, to participate in the study.
Exclusion criteria
Exclusion criteria: • The subject has a history of hypersensitivity to pleuromutilin or any of the ointment components. • The subject has an animal / human bite or a secondaryly infected puncture wound. • The subject has an abscess; defined as a localized collection of pus caused by deep tissue suppuration. • The subject has a chronic ulcerative lesion probably polymicrobial and unlikely caused by agents such as Staphylococcus aureus or Streptococcus pyogenes. • The subject has an underlying skin disease, such as a preexisting eczematous dermatitis, with clinical evidence of secondary infection. • The subject has systemic signs and symptoms of infection (eg, fever; defined by a rectal temperature / temperature greater than 101® F or 38.3® C). • The subject has a bacterial skin infection that, due to its depth or severity and at the discretion of the investigator, cannot be properly treated with a topical antibiotic. • The subject requires a surgical intervention to treat the infection before being enrolled in the study or will likely require such intervention during the study. • The subject has received systemic antibacterials or steroids or has applied any topical therapeutic agent (including but not limited to glucocorticoids, antibacterials and antifungals) directly on the wound within 24 hours prior to admission to the study. • The subject has a serious underlying disease that could be at imminent risk of death. • The patient is pregnant, breastfeeding or plans to become pregnant during the study or is at her fertile age or is less than one year postmenopausal and does not use accepted contraceptive methods (ie surgical sterilization, intrauterine contraceptive device, oral contraceptive plus one barrier) , diaphragm or condom combined with cream, gel or contraceptive foam). • The patient has used an investigational drug within 30 days prior to admission to the study. • The subject has been previously enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical Success at follow-up was defined as Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of 0. Clinical response at follow-up was classified as Clinical Failure for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items. Measure:Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population Timepoints:Days 12-14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical Success at follow-up was defined as Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of 0. Clinical response at follow-up was classified as Clinical Failure for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items. Measure:Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Intent-to-Treat Bacteriology (ITTB) Subset of the Primary Efficacy Population Timepoints:Days 12-14 ; Outcome name:The by pathogen microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The by subject microbiological response was Microbiological Success if the microbiological outcomes for all baseline pathogens (bps) belong to Eradication (elimination of bps), Presumed Eradication (clinical outcome was success; no culture was obtained due to lack of culturable material), or Colonization (previously unidentified pathogen is identified at end of therapy in participant who is resolved/improved); otherwise, response was Microbiological Failure. Measure:Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy) Timepoints:Days 12-14 ; Outcome name:Clinical outcome is determined by the investigator based on signs and symptoms (S/S) at the end of therapy evaluation. The 4 clincal outcome categories are: clinical success, resolution of clinically meaningful S/S of infection recorded at baseline (BL), including a pus/exudates score of 0; clinical improvement, improvement of S/S of infection recorded at BL to such an extent that no further antimicrobial therapy is necessary; cli | — |
Countries
Argentina, Brazil, India, Peru, Philippines, South Africa, United States
Outcome results
None listed