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
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|
|Study Type :||Observational|
|Actual Enrollment :||1007 participants|
|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|
- Clostridium difficile infection [ Time Frame: 28 days ]
- 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)
Biospecimen Retention: Samples With DNA
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 ClinicalTrials.gov identifier (NCT number): NCT02896244
|Principal Investigator:||Marc Bonten, MD, PhD||UMC Utrecht|