PERFORMANCE OF STOOL AND SERUM CYTOMEGALOVIRUS REAL-TIME POLYMERASE CHAIN REACTION AND THEIR COMBINATION IN DIAGNOSING CMV COLITIS

Completed

• Registration Number: TCTR20220828001
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

The combination of stool and serum CMV-PCR could be beneficial in diagnosing CMV colitis. Positive results of both might be used for ruling in, while negative results of both may rule out CMV colitis.

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-10-31
• Study Start: 2022-08-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Patients older than 18 years with clinical suspicion of CMV colitis were enrolled. The criteria for clinically suspicious of CMV colitis included:
i) presence of at least one of the risk factors, including human immunodeficiency virus infection, solid organ or hematologic stem cell transplantations, hematologic malignancy, inflammatory bowel disease, taking immunosuppressive agents or chemotherapy, and critically ill with multiple comorbidities, and
ii) presenting with gastrointestinal tract symptoms, including abdominal pain, gastrointestinal bleeding, diarrhea, and bowel ileus.

Exclusion Criteria

Patients who cannot undergo colonoscopy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performance After colonoscopy Sensitivity, Specificity

Secondary Outcome Measures

Name	Time	Method
Correlation between stool, serum, tissue CMV-PCR At diagnosis Pearson correlation