Clostridium DifficileANTICIPATENCT02896244
AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
An observational study of Clostridium Difficile, run by MJM Bonten at 34 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Clostridium Difficile
- How many people
- 1,007 participants
- Where
- 34 sitesin 6 countries
- Study dates
- 27 Sep 2016to 8 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- Clindamycin
- Carbapenems
- Written informed consent provided prior to inclusion.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
34 sites in 6 countries.
34 sites in 6 countries
France8 sites
CHD Vendee
La Roche-sur-Yon
CHU Dupuytren
Limoges
APHP Beaujon
Paris
APHP Bichat
Paris
APHP Hôpital Cochin
Paris
Hôpital St Louis
Paris
CH de Cornouaille
Quimper
Centre Hospitalier Universitaire de Tours
Tours
Germany8 sites
Uniklinik der RWTH
Aachen
Uniklinik Köln
Cologne
Universitätsklinikum Essen
Essen
Universitatsklinikum Heidelberg
Heidelberg
Universitätsklinikum Jena
Jena
UK Leipzig
Leipzig
Universitätsklinikum Schleswig-Holstein, Lübeck
Lübeck
Klinikum der Universität München
München
Spain7 sites
Bellvitge Hospital
Barcelona
Hospital Universitari Vall d´Hebrón
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Gregorio Marañon
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Virgen Macarena
Seville
Greece5 sites
Evangelismos General Hospital of Athens
Athens
Ippokratio Hospital of Athens
Athens
Laiko General Hospital
Athens
University General Hospital ATTIKON
Athens
University Hospital of Heraklion
Irakleio
Romania5 sites
Infectious and Tropical Diseases Hospital "Dr. Victor Babes"
Bucharest
The National Institute of Infectious Diseases Matei Bals
Bucharest
Cluj Napoca Infectious disease Clinical Hospital
Cluj-Napoca
Oncology Institute Ion Chiricuta Cluj Napoca
Cluj-Napoca
Clinical Hospital Of Infectious Diseases Of Iasi
Iași
About this study
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.
Read more
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.
- Conditions
- Clostridium Difficile
- Being tested
- no intervention
- Keywords
- Clostridium difficile, Clostridium difficile infection, antibiotics, antibiotics associated diarrhea, microbiome, microbiota
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Clostridium difficile infection
Measured: 28 days
Secondary outcomes (4)
Clostridium difficile infection
Measured: 90 days
Antibiotics associated diarrhea
Measured: 90 days
Bacterial diversity
Change from baseline to day 6 of bacterial diversity and composition of the intestinal microbiome
Measured: 6 days
Urine sulfate levels
Change from baseline to day 6 of 3-indoxyl sulfate levels in urine (corrected for the urine creatinine levels)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start27 Sep 2016
- Primary completion23 Jan 2018
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- MJM Bonten
- Sponsor type
- University, hospital or other
- Collaborators
- Da Volterra, Universitätsklinikum Köln, Universiteit Antwerpen
- Responsible party
- Sponsor-investigator, MJM Bonten, UMC Utrecht
- Investigators
- Marc Bonten, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896244
- Sponsor's protocol ID
- COMBACTE WP7
- Acronym
- ANTICIPATE
- Status last verified
- May 2021
- First submitted
- 6 Sep 2016
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 16S rRNA and shotgun metagenomic sequence data generated and analyzed in this study have been deposited in the NCBI Sequence Read Archive with the accession code PRJNA685914. Human reads were identified and removed prior to shotgun metagenomics data upload. Access to clinical data is restricted as the informed consent provided does not allow for use of clinical data outside the research institution. Data are available from the corresponding author upon reasonable requests.
Publications
van Werkhoven CH, Ducher A, Berkell M, Mysara M, Lammens C, Torre-Cisneros J, Rodriguez-Bano J, Herghea D, Cornely OA, Biehl LM, Bernard L, Dominguez-Luzon MA, Maraki S, Barraud O, Nica M, Jazmati N, Sablier-Gallis F, de Gunzburg J, Mentre F, Malhotra-Kumar S, Bonten MJM, Vehreschild MJGT; ANTICIPATE Study Group. Incidence and predictive biomarkers of Clostridioides difficile infection in hospitalized patients receiving broad-spectrum antibiotics. Nat Commun. 2021 Apr 14;12(1):2240. doi: 10.1038/s41467-021-22269-y.
PubMed 33854064Berkell M, Mysara M, Xavier BB, van Werkhoven CH, Monsieurs P, Lammens C, Ducher A, Vehreschild MJGT, Goossens H, de Gunzburg J, Bonten MJM, Malhotra-Kumar S; ANTICIPATE study group. Microbiota-based markers predictive of development of Clostridioides difficile infection. Nat Commun. 2021 Apr 14;12(1):2241. doi: 10.1038/s41467-021-22302-0.
PubMed 33854066
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
- ClinicalTrials.gov ID
- NCT02896244
- Acronym / sponsor ID
- ANTICIPATE / COMBACTE WP7
- Conditions
- Clostridium Difficile
- Keywords
- Clostridium difficile, Clostridium difficile infection, antibiotics, antibiotics associated diarrhea, microbiome, microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- MJM BontenUniversity, hospital or other
- Collaborators
- Da Volterra, Universitätsklinikum Köln, Universiteit Antwerpen
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- Written informed consent provided prior to inclusion.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | – |
Primary outcome
Clostridium difficile infection
Time frame: 28 days
4 secondary outcomes
Clostridium difficile infection
Time frame: 90 days
Antibiotics associated diarrhea
Time frame: 90 days
Bacterial diversity
Time frame: 6 days
Urine sulfate levels
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Results publication: PubMed 33854064van Werkhoven CH, Ducher A, Berkell M, Mysara M, Lammens C, Torre-Cisneros J, Rodriguez-Bano J, Herghea D, Cornely OA, Biehl LM, Bernard L, Dominguez-Luzon MA, Maraki S, Barraud O, Nica M, Jazmati N, Sablier-Gallis F, de Gunzburg J, Mentre F, Malhotra-Kumar S, Bonten MJM, Vehreschild MJGT; ANTICIPATE Study Group. Incidence and predictive biomarkers of Clostridioides difficile infection in hospitalized patients receiving broad-spectrum antibiotics. Nat Commun. 2021 Apr 14;12(1):2240. doi: 10.1038/s41467-021-22269-y.
- Results publication: PubMed 33854066Berkell M, Mysara M, Xavier BB, van Werkhoven CH, Monsieurs P, Lammens C, Ducher A, Vehreschild MJGT, Goossens H, de Gunzburg J, Bonten MJM, Malhotra-Kumar S; ANTICIPATE study group. Microbiota-based markers predictive of development of Clostridioides difficile infection. Nat Commun. 2021 Apr 14;12(1):2241. doi: 10.1038/s41467-021-22302-0.
- COMBACTE consortium website: ANTICIPATE is WP7 of COMBACTELink provided by the sponsor.
- Individual participant dataSharing planned: No. 16S rRNA and shotgun metagenomic sequence data generated and analyzed in this study have been deposited in the NCBI Sequence Read Archive with the accession code PRJNA685914. Human reads were identified and removed prior to shotgun metagenomics data upload. Access to clinical data is restricted as the informed consent provided does not allow for use of clinical data outside the research institution. Data are available from the corresponding author upon reasonable requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Bonten, MD, PhD principal investigator
UMC Utrecht
34 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile, run by MJM Bonten at 34 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in France, Germany, Spain, Greece, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clostridium difficile infection (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02896244, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.