NCT02951481

Brief Summary

The purpose of this study is to determine whether a bundle of measures specifically designed for patients with ICD and applied by and Infectious Diseases expert during a year period (2017) will improve the prognosis and reduce the rate of recurrence, compared with the baseline phase (2015) in which no intervention was made.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

October 29, 2020

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

October 28, 2016

Results QC Date

July 28, 2020

Last Update Submit

March 30, 2022

Conditions

Clostridium DifficileEnterocolitis, Pseudomembranous

Keywords

Clostridium difficile.Antimicrobial Stewardship.Enterocolitis, Pseudomembranous

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clostridium Difficile Infection Recurrence.

    Number of patients with a Clostridium difficile infection recurrence in each group within the following 8 weeks after the end of specific treatment for the initial Clostridium difficile infection episode.

    Within 8 weeks after the end of treatment.

Secondary Outcomes (7)

  • Number of Participants Experiencing More Than One Clostridium Difficile Infection Recurrence.

    8 weeks after the end of specific treatment for the first recurrence of Clostridium difficile infection.

  • Number of Participants With The Right Choice Anti-Clostridium Difficile Infection Treatment (According to the Current Guidelines for Treatment of C. Difficile Infection).

    In the following 48 hours to the positive diagnostic result.

  • Number of Participants With a Clostridium Difficile Infection That Received an Inappropriate Prescription by Overuse.

    In the following 48 hours to the positive diagnostic result.

  • Number of Participants With a Clostridium Difficile Infection That Received an Inappropriate Prescription by Underuse.

    In the following 48 hours to the positive diagnostic result.

  • Number of Participants With Antimicrobial Adjustment.

    In the following 2 weeks to the positive diagnostic result.

  • +2 more secondary outcomes

Study Arms (2)

Systematic evaluation by an ID expert.

Patients diagnosed with CDI during 2017 in the University Hospital 12 de Octubre will be systematically evaluated by an Infectious Disease expert to ensure compliance with clinical practice guidelines about specific treatment for CDI, depending on the severity of the episode and the existence of previous episodes. This group of patients will also receive a close follow up during the period of greatest risk of relapse (8 weeks after completion of antibiotic treatment for CDI) in order to reduce as far as possible, the number of relapses.

Behavioral: Systematic evaluation by an ID expert.

Retrospective historic cohort.

Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.

Interventions

Systematic evaluation by an ID expert.BEHAVIORAL

Specific "bundle" of measures: 1. Systematic evaluation of all patients diagnosed with CDI by an Infectious Disease expert To ensure compliance with clinical practice guidelines about specific treatment for CDI, depending on the severity of the episode and the existence of previous episodes and to optimize concomitant antibiotic therapy ("antimicrobial stewardship"). 2. To ensure appropriate monitoring during the period of greatest risk of relapse in order to reduce as far as possible, the number of relapses. Personalized assistance by telephone or by email for early consultation in case of recurrence of symptoms or need for a new antibiotic course.

Systematic evaluation by an ID expert.

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre (retrospective historic cohort) or adult patients diagnosed with CDI during 2017 in the University Hospital 12 de Octubre (prospective cohort in which intervention was made).

You may qualify if:

  • Patients diagnosed with CDI in the University Hospital "12 de Octubre", Madrid, Spain, requiring hospitalization or emergency room admission longer than 48 hours, from the beginning of the study on (estimated start date: January 2017).
  • Patient or his/her representative sign the inform consent

You may not qualify if:

  • Patients younger than 18 years of age.
  • Patients with the diagnosis of inflammatory bowel disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad de Enfermedades Infecciosas. Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Related Publications (5)

  • Debast SB, Bauer MP, Kuijper EJ; European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014 Mar;20 Suppl 2:1-26. doi: 10.1111/1469-0691.12418.

    PMID: 24118601BACKGROUND

  • Srigley JA, Brooks A, Sung M, Yamamura D, Haider S, Mertz D. Inappropriate use of antibiotics and Clostridium difficile infection. Am J Infect Control. 2013 Nov;41(11):1116-8. doi: 10.1016/j.ajic.2013.04.017. Epub 2013 Aug 7.

    PMID: 23932828BACKGROUND

  • Vonberg RP, Kuijper EJ, Wilcox MH, Barbut F, Tull P, Gastmeier P; European C difficile-Infection Control Group; European Centre for Disease Prevention and Control (ECDC); van den Broek PJ, Colville A, Coignard B, Daha T, Debast S, Duerden BI, van den Hof S, van der Kooi T, Maarleveld HJ, Nagy E, Notermans DW, O'Driscoll J, Patel B, Stone S, Wiuff C. Infection control measures to limit the spread of Clostridium difficile. Clin Microbiol Infect. 2008 May;14 Suppl 5:2-20. doi: 10.1111/j.1469-0691.2008.01992.x.

    PMID: 18412710BACKGROUND

  • Aldeyab MA, Kearney MP, Scott MG, Aldiab MA, Alahmadi YM, Darwish Elhajji FW, Magee FA, McElnay JC. An evaluation of the impact of antibiotic stewardship on reducing the use of high-risk antibiotics and its effect on the incidence of Clostridium difficile infection in hospital settings. J Antimicrob Chemother. 2012 Dec;67(12):2988-96. doi: 10.1093/jac/dks330. Epub 2012 Aug 16.

    PMID: 22899806BACKGROUND

  • Slayton RB, Scott RD, Baggs J, Lessa FC, McDonald LC, Jernigan JA. The cost-benefit of federal investment in preventing Clostridium difficile infections through the use of a multifaceted infection control and antimicrobial stewardship program. Infect Control Hosp Epidemiol. 2015 Jun;36(6):681-7. doi: 10.1017/ice.2015.43. Epub 2015 Mar 18.

    PMID: 25783204BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

As patients with CDI are going to be prospectively followed, apart from the routine hematology and biochemistry analysis, serum immunoglobulin levels, serum complement levels (C3 and C4) and peripheral blood lymphocyte subpopulations will be measured at the end of CDI treatment. The levels of these immunological parameters will be tested as markers for relapse by retrospectively comparing them between patients with and without recurrence. A stool sample will be collected at the end of treatment to evaluate predictors of bad outcome or recurrence: Inflammatory markers (lactoferrin, calprotectin) We will retrospectively compare these parameters between patients with and without recurrence.

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Limitations and Caveats

The main limitation could be that both populations (retrospective group and group of intervention) are not totally comparable and the change in recommendations over time between the 2 periods.

Results Point of Contact

Title
MD, PhD José María Aguado García
Organization
Fundación de investigación Hospital Universitario 12 de Octubre
jaguadog1@gmail.com
913908000

Study Officials

  • Jose María Aguado, MD. PhD

    University Hospital 12 de Octubre. Head of Infectious Disease Unit.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
José María Aguado García, MD, PhD

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 1, 2016

Study Start

February 15, 2017

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

April 1, 2022

Results First Posted

October 29, 2020

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)