Status:
COMPLETED
Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Conditions:
Clostridioides Difficile Infection
Stool Microbiome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 patie...
Detailed Description
Clostridioides difficile infection (CDI) is an emerging infection with increased point-prevalence per year as reported both for the United States and for European countries. Current evidence suggests ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05304715
Start Date
April 13 2022
End Date
June 4 2023
Last Update
December 15 2023
Active Locations (11)
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1
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Alexandroupoli, Greece, 68100
2
1st Department of Internal Medicine, THRIASIO General Hospital of Eleusis
Athens, Greece, 10918
3
2nd Department of Internal Medicine, Thriasio General Hospital
Athens, Greece, 10918
4
1st University Department of Internal Medicine, LAIKO General Hospital of Athens,
Athens, Greece, 11527