Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00237653
Status:
TERMINATED
Last Update Posted:
2009-04-03
First Post:
2005-10-11
Brief Title:
MICI-CMVValganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Relevance of Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus
Status:
TERMINATED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty to include patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
A third hypothesis is that infection by CMV aggravates inflammatory bowel diseases acting as an exacerbating factor
In all cases people suffering from CIBD are highly-exposed to infection by CMV due to immunosuppressive treatment corticoids cyclosporine azathioprin and methotrexate and the inflammation itself which is supposed to be a proning factor
CMV AND POUCHITIS
Pouchitis is the most common long-term complication after total proctocolectomy Usually it can be cured by antibiotic therapy but in 15 of cases it becomes chronic and turns onto refractory pouchitis which is difficult to cure
Infection by CMV can imitate a chronic pouchitis from a clinical and endoscopic view In such cases it had been shown that Valganciclovir treatment 10mgkgday led to significant improvement over a 21 day treatment period
CONCLUSION
Infection by CMV seems to play an important role and has to be taken into account in CIBD physiopathogeny Probably underestimated since it is not necessarily searched it could be a triggering factor or a treatment resistance factor Immunosuppressive drugs used towards recurrent bouts in particularly cyclosporine favors viral reactivation Then recurrent bouts of CIBD may be complicated by CMV infection That is why it could be interesting to establish relevance of antiviral treatment on recurrent bouts of CIBD with infection by CMV
The main objective of this study is to demonstrate relevance of Valganciclovir on recurrent bouts of Cryptogenic Inflammatory Bowel Diseases with infection by Cytomegalovirus The goal is to obtain 90 for Valganciclovir treated patients versus 50 for placebo treated patients of 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
Secondary objectives are
Reversal of CMV immunoglobulin G serology and PCR results on colonic biopsies
Improvement in appearance of histological lesions
Reduction in the number of colectomies
Evaluation of Valganciclovir tolerance and its side effects
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
A third hypothesis is that infection by CMV aggravates inflammatory bowel diseases acting as an exacerbating factor
In all cases people suffering from CIBD are highly-exposed to infection by CMV due to immunosuppressive treatment corticoids cyclosporine azathioprin and methotrexate and the inflammation itself which is supposed to be a proning factor
CMV AND POUCHITIS
Pouchitis is the most common long-term complication after total proctocolectomy Usually it can be cured by antibiotic therapy but in 15 of cases it becomes chronic and turns onto refractory pouchitis which is difficult to cure
Infection by CMV can imitate a chronic pouchitis from a clinical and endoscopic view In such cases it had been shown that Valganciclovir treatment 10mgkgday led to significant improvement over a 21 day treatment period
CONCLUSION
Infection by CMV seems to play an important role and has to be taken into account in CIBD physiopathogeny Probably underestimated since it is not necessarily searched it could be a triggering factor or a treatment resistance factor Immunosuppressive drugs used towards recurrent bouts in particularly cyclosporine favors viral reactivation Then recurrent bouts of CIBD may be complicated by CMV infection That is why it could be interesting to establish relevance of antiviral treatment on recurrent bouts of CIBD with infection by CMV
The main objective of this study is to demonstrate relevance of Valganciclovir on recurrent bouts of Cryptogenic Inflammatory Bowel Diseases with infection by Cytomegalovirus The goal is to obtain 90 for Valganciclovir treated patients versus 50 for placebo treated patients of 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
Secondary objectives are
Reversal of CMV immunoglobulin G serology and PCR results on colonic biopsies
Improvement in appearance of histological lesions
Reduction in the number of colectomies
Evaluation of Valganciclovir tolerance and its side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None