Gemifloxacin Versus Ciprofloxacin Versus Rifampicin in Treatment of Rhinoscleroma
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- clinical examination., nasal crustation,
研究概览
简要总结
gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma
详细描述
Rhinoscleroma is a chronic specific granulomatous inflammation affecting nose in 95-100% but can affect any part of respiratory tract.(1)
It is an endemic disease in Egypt. It is endemic as well in sporadic areas worldwide including Central America, Chili, Central Africa, India, Indonesia and Middle East countries.(2) It is completely eradicated from the developed communities.
If not treated early, the disease progresses to the final sclerotic phase where permanent complications including nasal deformities, anosmia, dysphonia, dysphagia and stridor could happen.(3-5)
Of the wide treatments range (antibiotic combinations, cytostatic drugs, radiation, and laser), none is ideal. The causative organism is resistant to most antibiotics and, being intracellular, is not always exposed to sufficient concentrations of drug. A clinical cure is hard to identify because the end-stage is mucosal fibrosis which, even without active infection, interferes with normal function of the upper respiratory tract. The fibrosed mucosa, especially in crusts, can become secondarily infected with bacteria, which may include klebsiella.(6)
Rifampin (7), streptomycin (8), ciprofloxacin (5) and levofloxacin (9) have been used in treatment of rhinoscleroma.
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
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years
- •Active rhinoscleroma proved both clinically and histopathologically
排除标准
- •Patients younger than 18 years old.
- •inactive Rhinoscleroma
- •Contraindication to treatment severe renal or hepatic impairment
- •Refusal of enrollment in the research by the patient
研究组 & 干预措施
gemifloxacin and Rifampicin
first group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once dailygroup will be given the usual regimen given for free by the Ministry of Health in Egypt; Rifampicin 300 mg twice daily for three months..
干预措施: Gemifloxacin (Drug)
gemifloxacin and Rifampicin
first group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once dailygroup will be given the usual regimen given for free by the Ministry of Health in Egypt; Rifampicin 300 mg twice daily for three months..
干预措施: Ciprofloxacin (Drug)
gemifloxacin and Rifampicin
first group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once dailygroup will be given the usual regimen given for free by the Ministry of Health in Egypt; Rifampicin 300 mg twice daily for three months..
干预措施: Rifampicin (Drug)
gemifloxacin and ciprofloxacin
. group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily group will be given a short course (four weeks) of oral Ciprofloxacin 750 mg twice daily
干预措施: Gemifloxacin (Drug)
gemifloxacin and ciprofloxacin
. group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily group will be given a short course (four weeks) of oral Ciprofloxacin 750 mg twice daily
干预措施: Ciprofloxacin (Drug)
gemifloxacin and ciprofloxacin
. group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily group will be given a short course (four weeks) of oral Ciprofloxacin 750 mg twice daily
干预措施: Rifampicin (Drug)
gemifloxacin and placipo
.group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily
干预措施: Gemifloxacin (Drug)
gemifloxacin and placipo
.group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily
干预措施: Ciprofloxacin (Drug)
gemifloxacin and placipo
.group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily
干预措施: Rifampicin (Drug)
结局指标
主要结局
clinical examination., nasal crustation,
时间窗: monthly evaluation for 6 months
nasal crusting, O= no symptoms, 1 = present monthly 2= present weekly, 3 = present daily, 4 = always present, and 5 = incapacitating). (6)
clinical examination purulent secretions
时间窗: monthly evaluation for 6 months
purulent secretions (O= no symptoms, 1 = present monthly 2= present weekly, 3 = present daily, 4 = always present, and 5 = incapacitating). (6)
• Full ENT history
时间窗: monthly evaluation for 6 months
purulent rhinorrhea, postnasal discharge, nasal crustation, hyposmia, and nasal obstruction
次要结局
未报告次要终点
研究者
asmaa ahmed bekheit
Principal Investigator
Assiut University