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

Study Overview
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Brief Summary
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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.

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

Conditions
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Clostridium Difficile

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clostridium difficile infection |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clostridium difficile infection |  | 90 days | 
| Antibiotics associated diarrhea |  | 90 days | 
| Bacterial diversity | Change from baseline to day 6 of bacterial diversity and composition of the intestinal microbiome | 6 days | 
| Urine sulfate levels | Change from baseline to day 6 of 3-indoxyl sulfate levels in urine (corrected for the urine creatinine levels) | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridium difficile, Clostridium difficile infection, antibiotics, antibiotics associated diarrhea, microbiome, microbiota