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

Clostridium Difficile Clinical Trial

— ANTICIPATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896244
• Other study ID #: COMBACTE WP7
• Status: Completed
• Start date: September 27, 2016
• Est. completion date: March 8, 2018

Study information

• Verified date: May 2021
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1007
• Est. completion date: March 8, 2018
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Difficile
• Clostridium Infections
• Infection

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
France	CHD Vendee	La Roche-sur-Yon
France	CHU Dupuytren	Limoges
France	APHP Beaujon	Paris
France	APHP Bichat	Paris
France	APHP Hôpital Cochin	Paris
France	Hôpital St Louis	Paris
France	CH de Cornouaille	Quimper
France	Centre Hospitalier Universitaire de Tours	Tours
Germany	Uniklinik der RWTH	Aachen
Germany	Uniklinik Köln	Cologne
Germany	Universitätsklinikum Essen	Essen
Germany	Universitatsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Jena	Jena
Germany	UK Leipzig	Leipzig
Germany	Universitätsklinikum Schleswig-Holstein, Lübeck	Lübeck
Germany	Klinikum der Universität München	Munchen
Greece	Evangelismos General Hospital of Athens	Athens
Greece	Ippokratio Hospital of Athens	Athens
Greece	Laiko General Hospital	Athens
Greece	University General Hospital ATTIKON	Athens
Greece	University Hospital of Heraklion	Iráklion
Netherlands	University Medical Center	Utrecht
Romania	Infectious and Tropical Diseases Hospital "Dr. Victor Babes"	Bucharest
Romania	The National Institute of Infectious Diseases Matei Bals	Bucharest
Romania	Cluj Napoca Infectious disease Clinical Hospital	Cluj Napoca
Romania	Oncology Institute Ion Chiricuta Cluj Napoca	Cluj Napoca
Romania	Clinical Hospital Of Infectious Diseases Of Iasi	Iasi
Spain	Bellvitge Hospital	Barcelona
Spain	Hospital Universitari Vall d´Hebrón	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (4)

Lead Sponsor	Collaborator
MJM Bonten	Da Volterra, Universitätsklinikum Köln, Universiteit Antwerpen

Countries where clinical trial is conducted

France,  Germany,  Greece,  Netherlands,  Romania,  Spain, 

References & Publications (2)

Berkell 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 dif — View Citation

van Werkhoven CH, Ducher A, Berkell M, Mysara M, Lammens C, Torre-Cisneros J, Rodríguez-Baño 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, Mentré F, Malhotra-Kum — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clostridium difficile infection		28 days
Secondary	Clostridium difficile infection		90 days
Secondary	Antibiotics associated diarrhea		90 days
Secondary	Bacterial diversity	Change from baseline to day 6 of bacterial diversity and composition of the intestinal microbiome	6 days
Secondary	Urine sulfate levels	Change from baseline to day 6 of 3-indoxyl sulfate levels in urine (corrected for the urine creatinine levels)	6 days

External Links

•   COMBACTE consortium website: ANTICIPATE is WP7 of COMBACTE