Relevance of Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement of Crohns disease activity index score
研究概览
简要总结
The main objective of this study is to demonstrate the relevance of Valganciclovir on recurrent bouts of cryptogenic inflammatory bowel diseases with infection by cytomegalovirus (CMV). The goal is to obtain 90% (for Valganciclovir treated patients) versus 50% (for placebo treated patients) remission at 3 months (including the discontinuation of corticoids or reducing their dose to under 20 mg of prednisone equivalence), without any relapse over the 6 following months.
详细描述
The cytomegalovirus (CMV) is a DNA virus from the herpes virus family. It is passed on between humans and even if infection is widespread (50 to 80% of people older than 35 are CMV immunoglobulin G positive) it is often asymptomatic for immunocompetent people. However, for immunocompromised people, such an infection takes on particular frequency, expression and seriousness, with a high frequency of attack to the digestive track (CMV colitis).
For immunocompetent people, colitis causes feverish bloody diarrhea associated with abdominal pain. Colitis diagnosis is often late and cases with complications have been reported (digestive bleeding, toxic giant colon and perforation). The endoscopic aspect of colitis is not specific and diagnosis is based on serology, anatomopathology or immunochemistry. Recently, PCR approaches have allowed more sensitive diagnosis.
CMV INVOLVEMENT IN CIBD PHYSIOPATHOLOGY:
Even though CMV involvement in colitis is rare but sure for immunocompetent people, its involvement in CIBD triggering and morbidity has not been solved yet.
Some authors think infection by CMV may act on CIBD as a trigger factor; since 2 cases of CMV colitis coinciding with the onset of a CIBD have been reported. For other authors, infection by CMV acts by direct pathogenicity causing ulcerative lesions of colonic mucosa and just imitates a CIBD without triggering it.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from Crohn's disease, ulcerative colitis, unclassifiable colitis or pouchitis.
- •Disease needing to be treated by corticoids and/or immunosuppressive drugs.
- •Infection by cytomegalovirus.
- •New attack during the three previous months.
排除标准
- •Serious or complicated attack, needing to be operated.
- •Patient suffering from a psychiatric disease or is uncooperative.
- •Patient suffering from another serious disease.
- •Patient already participating in another clinical trial.
结局指标
主要结局
Improvement of Crohns disease activity index score
Anatomopathology: disappearance of viral infection criteria
Endoscopy: improvement in appearance of lesions, or healing
Anatomopathology: improvement of histological criteria, or total regression
Virology: reversal of CMV IgG serology and PCR results
Diminution or disappearance of gravity criteria
次要结局
未报告次要终点
