Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection (BEYOND)
Clostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome
About this trial
This is an interventional treatment trial for Clostridioides Difficile Infection focused on measuring Bezlotoxumab
Eligibility Criteria
Inclusion Criteria:
- Age equal to or above18 years.
- Both genders.
- Written informed consent provided by the patient or by their legal representative in case of patients unable to consent.
- In case of non-menopausal women, unwillingness to become pregnant during the study period. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study.
- Diarrhea defined as at least 3 episodes of unformed stool in the past 24hours.
- Positive stool for C.difficile. This is defined as any stool sample positive for the presence of glutamate dehydrogenase (GDH) and for the presence of toxin A and/or B.
- Positive BEYOND score i.e. meeting any of the following:
Gene score for susceptibility to CDI more than 53. The score is provided by the following equation:
(Carriage of C allele of rs12148744 x 27) - (carriage of C allele of rs714024 x 27) - (carriage of C allele of rs721059 x 29) + (carriage of T allele of rs4311028 x 33) - (carriage of A allele of rs62183547 x 25) + (carriage of C allele of rs1128266 x 12) - (carriage of T allele of rs4279595 x 17) + (carriage of G allele of rs175006 x 11) + (carriage of T allele of rs3859214 x 17) + (carriage of G allele of rs7222870 x 15) - (carriage of G allele of rs5086600 x 9) + (carriage of T allele of rs7240534 x 12) + (carriage of G allele of rs20911172 x 11) - (carriage of C allele of rs17680671 x 17) OR
Score provided by the following equation more than 9:
[Hemoglobin <9.5 g/dl x 10] + [serum urea >64.5 mg/dl x 14] + [serum interleukin-8 >227 pg/ml x 19] - [carriage of G allele of rs2091172 x 17] OR More than 3log10 of gammaproteobacteria or Enterobacteriaceae or Enterobacteriales in the stool
Exclusion Criteria:
- Age below 18 years
- Denial for written informed consent
- Known allergy to bezlotoxumab
- Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
Sites / Locations
- 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
- 1st Department of Internal Medicine, THRIASIO General Hospital of Eleusis
- 2nd Department of Internal Medicine, Thriasio General Hospital
- 1st Department of Internal Medicine, G. GENNIMATAS General Hospital of Athens,
- 1st University Department of Internal Medicine, LAIKO General Hospital of Athens,
- 1st University Department of Propaedeutic Surgery, IPPOKRATEION General Hospital
- 3rd University Department of Internal Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
- 2nd Department of Propaedeutic Internal Medicine, ATTIKON University General Hospital,
- 3rd Department of Surgery, ATTIKON University General Hospital
- 4th Department of Internal Medicine, Attikon University Hospital
- 1st Department of Internal Medicine, General University Hospital of Ioannina
- Department of Internal Medicine, Larissa University Hospital
- Department of Internal Medicine, University General Hospital of Patras PANAGIA I VOITHIA
- 2nd Department of Internal Medicine, Tzanneion General Hospital
- 1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
- 2nd Department of Surgery, G. GENNIMATAS General Hospital of Thessaloniki
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Bezlotoxumab
Patients will be treated with 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
Patients will be treated with bezlotoxumab at a dose of 10mg per kg of body weight (up to maximum of 1000mg) dissolved in 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.