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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1
Policlinico Gemelli
Roma, Italy, 00168