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New drug combo shows promise against deadly gut infection

NCT ID NCT05304715

Disease control Sponsor: Hellenic Institute for the Study of Sepsis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding the drug bezlotoxumab to standard treatment could prevent serious outcomes in people with a severe C. diff infection. Researchers used a special score to identify 44 high-risk patients. The goal was to see if the drug reduced organ failure, infection return, or death within 40 days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

44 people

The number who actually took part.

Started

Apr 2022

Finished

Jun 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis Clostridium infectious disease multiple organ dysfunction syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clostridioides difficile infection Clostridioides difficile infection recurrence Mortality Organ dysfunction syndrome Stool microbiome

Contacts and locations

Locations

  • 1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 54621, Greece

  • 1st Department of Internal Medicine, General University Hospital of Ioannina

    Ioannina, 45500, Greece

  • 1st Department of Internal Medicine, THRIASIO General Hospital of Eleusis

    Athens, 10918, Greece

  • 1st University Department of Internal Medicine, LAIKO General Hospital of Athens,

    Athens, 11527, Greece

  • 1st University Department of Propaedeutic Surgery, IPPOKRATEION General Hospital

    Athens, 11527, Greece

  • 2nd Department of Internal Medicine, Thriasio General Hospital

    Athens, 10918, Greece

  • 2nd Department of Internal Medicine, Tzanneion General Hospital

    Piraeus, 18536, Greece

  • 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis

    Alexandroupoli, 68100, Greece

  • 4th Department of Internal Medicine, Attikon University Hospital

    Athens, 12462, Greece

  • Department of Internal Medicine, Larissa University Hospital

    Larissa, 41334, Greece

  • Department of Internal Medicine, University General Hospital of Patras PANAGIA I VOITHIA

    Pátrai, 26504, Greece

More trials for these conditions

Other studies related to the condition(s) this trial covers.