Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection

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.

Study Overview

• Status: Unknown
• Conditions: Clostridium Difficile Infection

Detailed Description

Clostridium difficile infection (CDI), which is often a consequence of antibiotic therapy, is the most common and one of the most serious hospital-acquired illnesses. It causes a range of intestinal upset from mild diarrhoea to a life-threatening severe colitis. The incidence, recurrence and mortality rates of CDI have increased dramatically in recent years. Metronidazole is the recommended first-line antibiotic, with vancomycin and colectomy reserved for severe cases.

Although risk factors for developing CDI are well known, factors that predict outcome and/or recurrence of CDI are uncertain and lack specificity for intestinal inflammation. We wish to investigate if careful prospective monitoring of standard clinical and biochemical measures will be able to identify patients who will go on to fail primary treatment.

If one or more of these factors proves able to predict outcome, they could ultimately be used for early escalation of therapy with the aim of reducing morbidity, mortality and length of hospital stay.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Barts Health NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Barts Health NHS Trust

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Nil specific

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Inpatients who test positive for CDI; Observational study, hence no intervention will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure of primary treatment	Measures included in primary outcome: Ongoing diarrhoea (day 5), treatment escalation (within 5 days), colectomy for CDI (on index admission), death (on index admission)	within 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death, CDI recurrence and hospital re-admission with diarrhoea	Data will be collected for up to 3 months after completion of patient recruitment	Within 3 months of the initial diagnosis of CDI

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Investigators: Principal Investigator: David S Rampton, DPhil, FRCP, Barts Health NHS Trust, The Royal London Hospital (Endoscopy department), London, E1 1BB, United Kingdom

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: March 12, 2014
• First Submitted That Met QC Criteria: March 12, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Estimate): July 9, 2015
• Last Update Submitted That Met QC Criteria: July 8, 2015
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Treatment; Clostridium difficile; Prediction; Failure
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Clostridium Infections
• Other Study ID Numbers: 007512QM; Barts and The London Charity (Other Grant/Funding Number: 723/1309)