Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit
研究概览
简要总结
The purpose of this study is to document the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with bacterial infections, including impetigo, folliculitis, and minor soft tissue infections including secondarily infected eczema presumed to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to 98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound cultures will be collected, and then subjects will apply topical retapamulin twice daily for five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus aureus (MRSA) infection based on clinical presentation and physical exam, as well as bacteriological efficacy based on culture results. It is anticipated that approximately 75 patients will be enrolled, with expectation that approximately 50 of these patients will have MRSA infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 98 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients from 9 months of age up to 98 years of age.
- •Clinical diagnosis of impetigo, folliculitis, or minor soft tissue infection including secondarily infected eczema presumed to be caused by Staphylococcus aureus.
- •The patient, and if applicable the parent or guardian, is able to give informed consent
- •Females of child bearing potential have a negative urine pregnancy test.
- •Patient, and if applicable parent or guardian, are willing to and capable of complying with the study protocol.
排除标准
- •Subject who has used a topical antibacterial medication to the area being treated within the last 48 hours.
- •Subject who has been enrolled in a clinical trial within the last 30 days.
- •Subject with signs of systemic infection (such as fever), or with evidence of abscess or cellulitis at the site to be treated.
- •Subject has a bacterial skin infection which would not be appropriately treated by a topical antibiotic in the opinion of the investigator
- •Subjects who have taken oral antibiotics within the last 7 days.
- •Subjects with known sensitivity to the study medication.
- •The subject is pregnant or breastfeeding
研究组 & 干预措施
Retapamulin ointment 1%
干预措施: Retapamulin (Altabax) (Drug)
结局指标
主要结局
Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit
时间窗: 6 to 8 days after treatment
Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.
次要结局
- Clinical Response at Follow up as Assessed by a Rating Scale(6 to 8 days after treatment)
- Microbiologic Response at Follow up as Assessed by a Rating Scale(6 to 8 days after treatment)
- Number of Participants Who Were a Therapeutic Success(6 to 8 days after treatment)
- Erythema (Sign and Symptom of Infection) at Baseline(baseline)
- Erythema (Sign and Symptom of Infection) at Follow up(6 to 8 days after treatment)
- Purulence (Sign and Symptom of Infection) at Baseline(baseline)
- Purulence (Sign and Symptom of Infection) at Follow up(6 to 8 days after treatment)
- Crusting (Sign and Symptom of Infection) at Baseline(baseline)
- Crusting (Sign and Symptom of Infection) at Follow up(6 to 8 days after treatment)
- Tissue Edema (Sign and Symptom of Infection) at Baseline(baseline)
- Tissue Edema (Sign and Symptom of Infection) at Follow up(6 to 8 days after treatment)
- Tissue Warmth (Sign and Symptom of Infection) at Baseline(baseline)
- Tissue Warmth (Sign and Symptom of Infection) at Follow up(6 to 8 days after treatment)
- Pain (Sign and Symptom of Infection) at Baseline(baseline)
- Pain (Sign and Symptom of Infection) at Follow up(6 to 8 days after treatment)
- Wound Size at Baseline(baseline)
- Wound Size at Follow up(6 to 8 days after treatment)
- Number of Participants Reporting Any Adverse Event (AE)(baseline to 6 to 8 days after treatment)
研究者
Adelaide Hebert
Professor of Dermatology and Pediatrics
The University of Texas Health Science Center, Houston