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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02086916
Other study ID # 007512QM
Secondary ID Barts and The Lo
Status Active, not recruiting
Phase N/A
First received March 12, 2014
Last updated July 8, 2015
Start date October 2011
Est. completion date December 2015

Study information

Verified date March 2014
Source Barts & The London NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Test positive for CDI on stool analysis

- Inpatient at Barts Health NHS Trust at time of diagnosis

Exclusion Criteria:

- Nil specific

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Barts Health NHS Trust London

Sponsors (1)

Lead Sponsor Collaborator
Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
See also
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Recruiting NCT05192148 - Seroprevalence of Antibodies to Surface Antigens and Toxins of Clostridioides Difficile N/A
Completed NCT03250104 - Antibiotic Stewardship and Infection Control in Patients at High Risk of Developing Infection by Clostridium Difficile, Vancomycin-Resistant Enterococci or Multi-Resistant Gram-Negatives

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