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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02896244
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : May 11, 2018
Da Volterra
Universitätsklinikum Köln
Universiteit Antwerpen
Information provided by (Responsible Party):
MJM Bonten, UMC Utrecht

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.

Condition or disease Intervention/treatment
Clostridium Difficile Other: no intervention

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Study Type : Observational
Actual Enrollment : 1007 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
Actual Study Start Date : September 27, 2016
Actual Primary Completion Date : January 23, 2018
Actual Study Completion Date : March 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Primary Outcome Measures :
  1. Clostridium difficile infection [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Clostridium difficile infection [ Time Frame: 90 days ]
  2. Antibiotics associated diarrhea [ Time Frame: 90 days ]
  3. Bacterial diversity [ Time Frame: 6 days ]
    Change from baseline to day 6 of bacterial diversity and composition of the intestinal microbiome

  4. 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)

Biospecimen Retention:   Samples With DNA
Bacterial DNA from rectal swab samples

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02896244

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Sponsors and Collaborators
MJM Bonten
Da Volterra
Universitätsklinikum Köln
Universiteit Antwerpen
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Principal Investigator: Marc Bonten, MD, PhD UMC Utrecht
Additional Information:
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Responsible Party: MJM Bonten, Professor of molecular epidemiology of infectious diseases, head of department of medical microbiology, UMC Utrecht Identifier: NCT02896244    
Other Study ID Numbers: COMBACTE WP7
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by MJM Bonten, UMC Utrecht:
Clostridium difficile
Clostridium difficile infection
antibiotics associated diarrhea
Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections