Status:

RECRUITING

Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea

Lead Sponsor:

ABResearch S.r.l.

Collaborating Sponsors:

Nextrasearch S.r.l.s.

Conditions:

Clostridium; Difficile, As Cause of Disease Classified Elsewhere

Clostridium Difficile Diarrhea

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This is a single center, randomized, exploratory clinical investigation that will evaluate the safety and efficacy of Toxclean (ABResearch srl) as add on treatment to Standard therapy in 24 patients w...

Detailed Description

This is a single center, randomized, exploratory clinical investigation that will evaluate the safety and efficacy of Toxclean (ABResearch srl) as add on treatment to Standard therapy in 24 patients w...

Eligibility Criteria

Inclusion Criteria:

  • Age ≥ 18 years, male or female, at the time of informed consent
  • Signed informed consent by patient, or where applicable, patient's legally authorized representative;
  • Diagnosis of recurrent CDAD, defined as those episodes of C. Difficile associated diarrhea occurring 2-8 weeks after either the symptoms resolution of a previous CDAD episode or C. difficile negativization of fecal sample.
  • Detection of C. difficile toxins by nucleic acid amplification tests (NAAT), EIA or GDH;
  • Received at least one course of adequate antibiotic therapy for CDAD (≥ 10 days of vancomycin at a dose of ≥125 mg four times per day, ≥ 10 days of metronidazole at a dose of 500mg three times per day or fidaxomixin 200mg twice a day for 10 days)

Exclusion Criteria:

  • History of C. difficile complicating inflammatory bowel disease (Crohn's disease, ulcerative colitis), or history of bowel resection surgery (other than uncomplicated appendectomy) or history of other infectious diarrhea or diarrhea of unknown etiology since the initial episode of CDAD;
  • Participants who require oral anticoagulant medications, including but not limited to warfarin and NOACs (novel oral anticoagulants);
  • Major gastrointestinal surgery within 3 months of enrollment;
  • History of swallowing difficulties, including dysphagia or odynophagia for liquids or solids;
  • Clinically immunocompromised due to any primary immune or autoimmune deficiency, as a result of chronic disease, cancer or medication used to treat these diseases
  • Consumption of the following prescription medications during the current enrollment episode: Bezlotuxamab/Zinplava Is pregnant or lactating Known hypersensitivity to the active principle or excipients

Key Trial Info

Start Date :

January 27 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT06839209

Start Date

January 27 2025

End Date

December 31 2025

Last Update

February 26 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Policlinico Gemelli

Roma, Italy, 00168

Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea | DecenTrialz