Phase 4 Study of Azitromicin in the Treatment of PID
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- to compare two oral antibiotic protocols in terms of side effects and efficacy.
研究概览
简要总结
Objective: To compare two oral treatments: Ofloxacin + Metronidazole, and Azitromycin +Metronidazole in outpatients with Pelvic Inflammatory Disease.
Materials and Methods: Two hundred patients divided to two groups( A , B). Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy
详细描述
Two hundred patients divided to two groups( A , B). Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria were having three out of five following symptoms: a-lower abdominal pain, b-vaginal discharges, c- adnexal tenderness, d-cervical motion tenderness (CMT), e-cervisitis.
排除标准
- •Excluding criteria were as follows: a-unmarried women, b-pregnant women, c-women with infection during menstruation, d- history of abortion or miscarriage during the last month, e-underlying diseases such as diabetes, f-used antibiotics in the last month, or allergy to the antibiotics used in the study, g-history of Pelvic Inflammatory Disease within the last year, and h- suspicion of being multi partner.
研究组 & 干预措施
azitromicin,PID treatment,ofluxacin
干预措施: Ofloxacin group A, Azitromycin group B (Drug)
azitromicin,PID treatment,ofluxacin
干预措施: azitromycin (Drug)
结局指标
主要结局
to compare two oral antibiotic protocols in terms of side effects and efficacy.
时间窗: Jan 2010- Aug 2010
side effects- and efficacy
次要结局
- single oral dose of Azitromicine could be the drug of choice in the outpatient treatment of Pelvic Inflammatory Disease(Jan 2010- Aug 2010)