Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm in the Pediatric Population.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Participants With Abscess Resolution
研究概览
简要总结
The purpose of the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus non-antibiotic treatment after incision and drainage.
详细描述
This study is a randomized controlled trial of antibiotic treatment versus placebo after incision and drainage of skin and soft tissue abscesses less than 5 cm in pediatric patients. Eligible patients whose parents/guardians consented them to enrollment were randomized to receive one of two interventions: oral trimethoprim/sulfamethoxazole (TMP/SMX) or placebo after incision and drainage. Every attempt was made to make the placebo capsules and suspensions appear in all aspects like the true drug (was done by the investigational pharmacy department at our institution). Equal numbers of subjects were randomized at the outset to both study groups. Randomization, also done by our investigational pharmacy department, was done in blocks of 20. Patients were followed up in our emergency center at 24 to 48 hours to have any packing removed and to have their clinical/wound status assessed. They were not charged for this visit, and their valet parking was validated. If an individual patient, or an individual patient's wound, was felt to be not improving adequately, that patient was started on formal antibiotic therapy at the treating attending physician's discretion.
Primary outcome:
- Abscess resolution by parental report 7-10 days after incision and drainage
Secondary outcomes:
- Admission to the hospital because of worsening infection
- Receipt of antibiotics (placebo arm) or change in antibiotics (antibiotic arm)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 90 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.) Abscess < 5 cm (< 5 cm of induration and fluctuance) requiring incision and drainage 2.) Age > 90 days and < 18 years 3.) Abscess on the trunk, scalp, extremities, or axillae
排除标准
- •Multiple abscesses
- •Abscess located on the hands, face, or perineum
- •Abscess as a result of a bite wound
- •Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (> 10 days), etc.
- •Previously failed 48 hours or greater therapy on any antibiotic regimen 6.) Drug allergy to TMP/SMX
- •7.) Fever > or = 102.2 degrees Fahrenheit in the previous 24 hours 8.) Systemic symptoms on presentation - i.e., nausea , vomiting, persistent tachycardia, hypotension, diaphoresis, etc.
- •9.) Signs /symptoms of another infection or illness - i.e., influenza, croup, etc.
研究组 & 干预措施
oral trimethoprim/sulfamethoxazole
subjects with abscesses less than 5cm will be randomized to either study med or placebo
干预措施: oral trimethoprim/sulfamethoxazole (Drug)
placebo
Placebo after incision and drainage of abscess less than 5 cm.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Abscess Resolution
时间窗: 10 days
Outcomes will be measured by resolution of size, tenderness, and induration with erythema by parental report 7 - 10 days after initial visit to the Emergency Center
次要结局
- Number of Participants Requiring Admission for Failure of Abscess Resolution(10 days)
- Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve(10 days)
研究者
Andrea Cruz
Principal Investigator
Baylor College of Medicine