Mortality Clinical Trial
— BEYONDOfficial title:
Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection: The BEYOND Double-Blind Randomized Clinical Trial
Verified date | December 2023 |
Source | Hellenic Institute for the Study of Sepsis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | June 4, 2023 |
Est. primary completion date | June 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis | Alexandroupoli | |
Greece | 1st Department of Internal Medicine, THRIASIO General Hospital of Eleusis | Athens | |
Greece | 1st University Department of Internal Medicine, LAIKO General Hospital of Athens, | Athens | |
Greece | 1st University Department of Propaedeutic Surgery, IPPOKRATEION General Hospital | Athens | |
Greece | 2nd Department of Internal Medicine, Thriasio General Hospital | Athens | |
Greece | 4th Department of Internal Medicine, Attikon University Hospital | Athens | |
Greece | 1st Department of Internal Medicine, General University Hospital of Ioannina | Ioannina | |
Greece | Department of Internal Medicine, Larissa University Hospital | Larisa | |
Greece | Department of Internal Medicine, University General Hospital of Patras PANAGIA I VOITHIA | Patra | |
Greece | 2nd Department of Internal Medicine, Tzanneion General Hospital | Piraeus | |
Greece | 1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Hellenic Institute for the Study of Sepsis |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of bezlotoxumab over placebo on reducing the incidence of progression into organ dysfunction defined as any increase of the baseline total SOFA score by at least 2 points. | Progression into organ dysfunction is defined as any increase of the baseline total SOFA score by at least 2 points. Need for colectomy or admission in the Intensive Care Unit counts also as organ dysfunction. | 40 days | |
Primary | Comparison of bezlotoxumab over placebo on reducing the incidence of relapse of Clostridioides difficile infection | Relapse is defined as the return of more than three unformed bowel movements in 24 hours with a positive stool toxin test necessitating retreatment | 40 days | |
Primary | Comparison of bezlotoxumab over placebo on reducing the incidence of death | Death | 40 days | |
Secondary | Comparison of bezlotoxumab over placebo regarding the time to first organ dysfunction | This is defined as the presentation of organ dysfunction in any of the enrolled patients of each group starting from the day of blind allocation until Day 40. | 1-40 days | |
Secondary | Comparison of bezlotoxumab over placebo regarding the time to relapse of CDI | The relapse of CDI is under daily follow-up until Day 40. Relapse is defined as the return of more than three unformed bowel movements in 24 hours with a positive stool toxin test necessitating retreatment. | 1-40 days | |
Secondary | Comparison of bezlotoxumab over placebo regarding survival time | Survival until Day 40 from study enrolment | 1-40 days | |
Secondary | Comparison of bezlotoxumab over placebo regarding overall cost of hospitalization | This is calculated starting from the day of blind allocation until Day 40 | 1-40 days | |
Secondary | Validation of the BEYOND score | This is done by comparing the incidence of the primary endpoint between patients who have failed screening in the trial and patients who were enrolled in the trial and who were allocated to the placebo arm. Positive BEYOND score is expected to be associated with worse outcome. | 1-40 days |
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