Accuracy of fecal cytomegalovirus (CMV) polymerase chain reaction in diagnosis of CMV colitis

Phase 2

Recruiting

• Conditions: CMV colitis; Stool CMV PCR, dignostic test of CMV colitis, tissue CMV PCR, cytomegalovirus

• Registration Number: TCTR20201120002
• Lead Sponsor: Faculty of Medicine Siriraj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-20
• Study Completion: 2022-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

1. Age > 18 year old
2. Patients who meet one of criteria in both 2.1 and 2.2
2.1)Patients at risk of CMV infection
- HIV infection
- Post organ transplant
- Hematologic malignancy
- Immunosuppressive agents
- Chemotherapeutic agents
- Advanced age with multiple co-morbidities
- Critically ill-patients
2.2) Patients present with symptoms suspicious CMV clolitis
- Abdominal pain
- Diarrhea
- LGIH
- Ileus
- Bowel perforation

Exclusion Criteria

Patients who cannot proceed colonoscopy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of stool CMV PCR in diagnosis of CMV colitis compared with tissue pathology at dignosis of CMV colitits Senstovity, specificity, accuracy of stool CMV PCR

Secondary Outcome Measures

Name	Time	Method
Correlation of quantitative stool CMV PCR and serum CMV viral load with tissue pathology at diagnosis of CMV colitis quantitative stool CMV PCR, serum CMV viral load,Association of quantitative stool CMV PCR to mortality rate, surgical rate, curative rate after diagnosis of CMV colitis to complete treatment quantitative stool CMV PCR, mortality rate, surgical rate, curative rate