Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection

NCT02086916 | Completed

• 2 other identifiers: 007512QMBarts and The London Charity
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Acquiring diarrhoea in hospital is a serious problem and most frequently occurs when susceptible patients receive antibiotics as part of their (often life-saving) care. The commonest cause is Clostridium difficile - a bacterium that normally lives in up to a third of us but causes no problems. Rates of infection had been falling with increased awareness and improved hygiene but they are starting to creep up again. Clostridium difficile can cause a range of disease from a short-lived mild diarrhoea to severe disease of the bowel with major effects on the whole body and even death. This study aims to identify substances in the stool and in the blood to enable doctors to predict how severe that individual's disease will be. These tests can easily be performed. If they prove accurate in identifying the subsequent severity of the patient's illness due to Clostridium difficile, patients predicted to develop the worst disease can receive the most intensive treatments before they become too unwell to benefit. On the other hand, patients whose disease is predicted by these markers to run its course without causing serious consequences can be spared the side effects and risks of more intensive treatment.

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficile; Prediction; Treatment; Failure

Outcome Measures

Primary Outcomes (1)

• Failure of primary treatment

  Failure of primary treatment Ongoing diarrhoea (day 5), treatment escalation (within 5 days), colectomy for CDI (on index admission), death (on index admission)

  1 week from diagnosis

Study Arms (1)

Inpatients who test positive for CDI

Observational study, hence no intervention will be administered

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Barts Health NHS Trust

You may qualify if:

• Test positive for CDI on stool analysis
• Inpatient at Barts Health NHS Trust at time of diagnosis

You may not qualify if:

• Nil specific

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts Health NHS Trust

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples from recruited participants are frozen and stored. They will be batch analysed after completion of recruitment.

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• David S Rampton, DPhil, FRCP

  Barts Health NHS Trust, The Royal London Hospital (Endoscopy department), London, E1 1BB, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 13, 2014
• Study Start: October 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)