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AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment (ANTICIPATE)

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ClinicalTrials.gov Identifier: NCT02896244
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : May 11, 2018
Sponsor:
Collaborators:
Da Volterra
Universitätsklinikum Köln
Universiteit Antwerpen
Information provided by (Responsible Party):
MJM Bonten, UMC Utrecht

Tracking Information
First Submitted Date September 6, 2016
First Posted Date September 12, 2016
Last Update Posted Date May 11, 2018
Actual Study Start Date September 27, 2016
Actual Primary Completion Date January 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2016)
Clostridium difficile infection [ Time Frame: 28 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 6, 2016)
  • Clostridium difficile infection [ Time Frame: 90 days ]
  • Antibiotics associated diarrhea [ Time Frame: 90 days ]
  • Bacterial diversity [ Time Frame: 6 days ]
    Change from baseline to day 6 of bacterial diversity and composition of the intestinal microbiome
  • Urine sulfate levels [ Time Frame: 6 days ]
    Change from baseline to day 6 of 3-indoxyl sulfate levels in urine (corrected for the urine creatinine levels)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
Official Title AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
Brief Summary

During or after antibiotic treatment, antibiotic residues impair the intestinal microbiota (gut flora) and lead to adverse effects such as the emergence of bacterial resistance or the occurrence antibiotic-associated diarrhoea (AAD) including antibiotic-induced C. difficile infection (CDI). The spread of resistant Gram-negative bacteria and the increasing number and severity of CDI are considered as worldwide public health threats.

Da Volterra is a biotechnology company developing a novel product, DAV132 (a medical device in Europe), intended to prevent these antibiotic adverse effects. Da Volterra is planning to carry out a phase 2-3 randomized controlled trial (RCT) of DAV132 in the prevention of antibiotic-induced CDI. The RCT will involve hospitalized patients aged ≥50 years old and treated with predefined antibiotic classes known to increase the risk of CDI. The incidence of CDI in this population is unknown, yet, incidence is an important determinant for the required sample size.

Therefore, the main objective of the current study is to assess CDI incidence in patients ≥50 years of age treated with predefined antibiotic classes.

In addition, to optimise the target population of the DAV132 RCT, the effect of the predefined antibiotic agents on the intestinal microbiota will be assessed. Furthermore, biomarkers predictive of CDI occurrence might help identify patients at high risk for the disease, which could further optimise the RCT. No validated biomarkers have been described in the literature yet. Assessment of potential biomarkers is another aim of the present study.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Bacterial DNA from rectal swab samples
Sampling Method Non-Probability Sample
Study Population Patients aged 50 or older receiving oral or intervenous antibiotic treatment with Third or fourth generation cephalosporins, Fluoroquinolones, Penicillins +beta-lactamase inhibitors, Clindamycin, or Carbapenems during hospitalization.
Condition Clostridium Difficile
Intervention Other: no intervention
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 4, 2018)
1007
Original Estimated Enrollment
 (submitted: September 6, 2016)
1000
Actual Study Completion Date March 8, 2018
Actual Primary Completion Date January 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Male or female hospitalized patient.
  2. Aged ≥ 50 years old.
  3. Initiation of intravenous or oral treatment with intended duration ≥5 days (≥1 day for clindamycin) with at least one of the following antibiotic classes, or treatment scheduled within the next 72 hours:

    • Third or fourth generation cephalosporins
    • Fluoroquinolones
    • Penicillins +beta-lactamase inhibitors
    • Clindamycin
    • Carbapenems
  4. Written informed consent provided prior to inclusion.

Exclusion Criteria:

  1. Ongoing antibiotic treatment with one of the above classes initiated >6 hours before inclusion into the study.
  2. ICU admission at the time of inclusion or anticipated admission within 48h.
  3. Suspected or diagnosed CDI, ongoing treatment for CDI, or diarrhoea at the time of inclusion.
  4. Patient with stoma.
  5. Subject has been included into this study previously.
  6. Patient treated with probiotics to prevent CDI.
  7. Patient with any social or logistical condition which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted after discharge.
  8. Subject is subject to legal protection.
  9. Subject deprived of liberty by judicial or administrative decision.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   Greece,   Netherlands,   Romania,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02896244
Other Study ID Numbers COMBACTE WP7
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party MJM Bonten, UMC Utrecht
Study Sponsor MJM Bonten
Collaborators
  • Da Volterra
  • Universitätsklinikum Köln
  • Universiteit Antwerpen
Investigators
Principal Investigator: Marc Bonten, MD, PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date May 2018