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Completed

NCT Number: NCT02896244

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

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.

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Key information

Conditions

Clostridium Difficile Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHD Vendee, La Roche-sur-Yon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female hospitalized patient.
  • Aged ≥ 50 years old.
  • 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
  • Written informed consent provided prior to inclusion.

Exclusion criteria

  • Ongoing antibiotic treatment with one of the above classes initiated >6 hours before inclusion into the study.
  • ICU admission at the time of inclusion or anticipated admission within 48h.
  • Suspected or diagnosed CDI, ongoing treatment for CDI, or diarrhoea at the time of inclusion.
  • Patient with stoma.
  • Subject has been included into this study previously.
  • Patient treated with probiotics to prevent CDI.
  • 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.
  • Subject is subject to legal protection.
  • Subject deprived of liberty by judicial or administrative decision.

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Clostridium difficile infection

    Time frame: 28 days

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

MJM Bonten

Other

Collaborators

  • Da Volterra
  • Universiteit Antwerpen
  • Universitätsklinikum Köln

Registry information

Acronym: ANTICIPATE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2016
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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