Clostridium; Difficile, As Cause of Disease Classified Elsewhere, Clostridium Difficile Diarrhea
Conditions
Keywords
clostridium difficile, clostridium, cdad
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 with recurrent CDAD. Eligible subjects will be adult patients with recurrent CDAD. Recurrent CDAD, for the purpose of this protocol, is defined as one or more new episode of diarrhea (Ned) within two months from the end of the SoC treatment. The objective of this pilot study is to evaluate whether 1 or 2 grams of Toxclean powder is orally administrable and well tolerated as add on treatment to SoC in patients with recurrent CDAD.
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 with recurrent CDAD. Eligible subjects will be adult patients with recurrent CDAD. Recurrent CDAD, for the purpose of this protocol, is defined as one or more new episode of diarrhea (Ned) within two months from the end of the SoC treatment. The objective of this pilot study is to evaluate whether 1 or 2 grams of Toxclean powder is orally administrable and well tolerated as add on treatment to SoC in patients with recurrent CDAD. Primary * Percentage of patients that complete Toxclean schedule treatment; Secondary * Safety and tolerability of two different dosage of oral Toxclean treatment; * Reduction of toxin amount in fecal sample; * Clinical response after 28-day oral administration of two different dosage of TOXCLEAN in combination with SoC therapy; * CDAD symptoms improvements during treatment and follow up periods; * Fecal concentration of Toxclean;
Interventions
DEVICEToxclean 1g
1 g of Toxclean once or twice daily for 28 days
Sponsors
Nextrasearch S.r.l.s.
ABResearch S.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Cohort A: 1 g of Toxclean once a day for 28 days plus SoC therapy Cohort B: 1 g of Toxclean twice daily for 28 days plus SoC therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients that complete Toxclean schedule treatment | 28 days | The primary objective of this early feasibility clinical study is to evaluate whether 1 or 2 grams of Toxclean powder is orally administrable and well tolerated as add on treatment to SoC in patients recurrent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the assessment of the safety and tolerability of two different dosage of oral Toxclean treatment | 28 days | Safety and tolerability of two dosage of oral Toxclean powder plus SoC assessed by number of participants who experienced adverse events |
| the clinical response after 14-day oral administration of two different dosage of TOXCLEAN in combination with SoC therapy; | 14 days | time to resolution of diarrhea: time in days from start of treatment to the first formed bowel movement |
| the CDAD symptoms improvements during treatment and follow up periods | 2 months | reduction of CDAD symptoms such as abdominal pain, nausea etc |
| Measurement of Toxclean fecal concentration of Toxclean | 28 days | C. difficile toxins in fecal sample; |
Countries
Italy
Contacts
Primary ContactGiovanni Cammarota, Professor
Outcome results
None listed