Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Previous data have shown that integrated information from single nucleotide polymorphisms (SNPs) of the host DNA, interleukin 8 (IL-8) and the enrichment of the stool microbiome can indicate the patients with infection by Clostridioides difficile (CDI) who are at risk for unfavorable outcome. This integrated information is forming the BEYOND score. The aim of the BEYOND randomized clinical trial (RCT) is to investigate if adjunctive bezlotoxumab treatment to the current standard-of-care may decrease the likelihood of unfavorable outcome for patients who score positive by the BEYOND score.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Institute for the Study of Sepsis

Criteria

Inclusion Criteria:

1. Age equal to or above18 years.

2. Both genders.

3. Written informed consent provided by the patient or by their legal representative in case of patients unable to consent.

4. 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.

5. Diarrhea defined as at least 3 episodes of unformed stool in the past 24hours.

6. 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.

7. 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