CMTS0929 for Clostridioides Difficile Infection

February 19, 2025 updated by: Faming Zhang, The Second Hospital of Nanjing Medical University

CMTS0929 for Clostridioides Difficile Infection: a Prospective, Open-label, Single-arm Clinical Study

This is a prospective, open-label, single-arm study to explore the safety and the efficacy of CMTS0929 for patients with Clostridioides difficile infection (CDI).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

At least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics and clinical data will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to enter the study:

  1. At the time of informed consent, the age is between 18 and 75 years old (inclusive), including both males and non - pregnant, non - lactating females.
  2. At the time of screening, meet the diagnostic criteria for Clostridioides difficile infection: a)There is a medical record proving a confirmed CDI before screening (laboratory tests show positive results for Clostridioides difficile or its toxins): positive results in Clostridioides difficile toxin detection (determined by EIAs) or colonoscopy indicating pseudomembranous colitis; or positive GDH with negative toxin results, along with obvious predisposing factors and diarrhea. b)Have an episode of CDI - related diarrhea, that is, having at least 3 bowel movements per day for at least two consecutive days and the stools are unformed (Bristol Stool Form Scale score of 6 - 7).
  3. The subject or their legal representative provides informed consent, fully understands the purpose of the study, can communicate well with the researcher, and can understand and comply with all the requirements of this study.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria must be excluded from the study:

  1. Subjects with immunodeficiency (such as HIV infection, or absolute neutrophil count < 0.5×10⁹/L, or total lymphocyte count < 0.5×10⁹/L, etc.), or those using immunosuppressants, or those using medium - to high - dose steroid hormones (≥20 g/d prednisone or equivalent steroid hormones).
  2. Subjects with rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis that, as evaluated by the researcher, cannot undergo cTET.
  3. Before screening, subjects are diagnosed or clinically suspected of having an infection with other pathogenic microorganisms in addition to Clostridioides difficile.
  4. Within 6 months before screening, subjects have undergone major abdominal surgery (excluding laparoscopic cholecystectomy or appendectomy), or have previously undergone partial or total colectomy, or partial small intestine resection, or gastroduodenal surgery.
  5. At the time of screening, the subject or legal representative refuses to use effective contraceptive measures within 3 months after the last treatment.
  6. As judged by the researcher, the subject is not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Eligible subjects will receive treatment with CMTS0929. They will be administered one unit of the liquid via colonic transendoscopic enteral tube (cTET) for three consecutive days.
Biological: CMTS0929
CMTS0929 is defined as suspension from washed microbiota.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The safety of CMTS0929
Time Frame: Four-week
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0: The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.)
Four-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The safety of CMTS0929
Time Frame: Immediately, One-week, Two-week, Eight-week, Twenty four-week
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0: The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.)
Immediately, One-week, Two-week, Eight-week, Twenty four-week
The complete response rate of CDI-related diarrhea
Time Frame: Four-week, Eight-week
Having no diarrhea for at least two consecutive days (with normal stool consistency (Bristol Stool Form Scale score ≤ 5) and 1-2 bowel movements per day).
Four-week, Eight-week
The ultra-early complete response rate of CDI-related diarrhea
Time Frame: One-week post treatment
Having no diarrhea for at least two consecutive days (with normal stool consistency (Bristol Stool Form Scale score ≤ 5) and 1-2 bowel movements per day).
One-week post treatment
The early complete response rate of CDI-related diarrhea
Time Frame: Two-week post treatment
Having no diarrhea for at least two consecutive days (with normal stool consistency (Bristol Stool Form Scale score ≤ 5) and 1-2 bowel movements per day).
Two-week post treatment
The non-response rate of CDI-related diarrhea
Time Frame: Two-week, Four-week, Six-week, Eight-week post treatment
Having at least 3 bowel movements per day for at least two consecutive days and the stools are unformed (Bristol Stool Form Scale score of 6-7), and further anti-CDI treatment is required.
Two-week, Four-week, Six-week, Eight-week post treatment
The recurrence rate of CDI-related diarrhea
Time Frame: Four-week, Six-week, Eight-week, Twenty four-week
After the disappearance of CDI-related diarrhea, the recurrence of CDI-related diarrhea occurs, and the detection of Clostridioides difficile toxins is positive (judged by glutamate dehydrogenase [GDH] and enzyme immunoassays [EIAs]).
Four-week, Six-week, Eight-week, Twenty four-week
The major disease progression rate of CDI
Time Frame: Twenty four-week
Progression to severe CDI (SCDI)/severe complicated CDI (ScCDI) (defined as high fever ≥ 38.5°C, white blood cell count > 15×10⁹/L, increased serum creatinine [> 50% higher than the baseline level], hypotension, septic shock, increased serum lactate [> 2.2 mmol/L], intestinal obstruction, toxic megacolon, intestinal perforation, or any fulminant course [i.e., the patient's condition deteriorates rapidly, or requires treatment in the intensive care unit (ICU), or is complicated by organ failure]), death, emergency colectomy, receiving ≥ 2 courses of fecal microbiota transplantation (FMT)/washed microbiota transplantation (WMT) or other forms of approved or investigational salvage therapy, or early withdrawal from the study or loss to follow-up)
Twenty four-week
The salvage/replacement treatment rate of CDI
Time Frame: Immediately, One-week, Two-week, Four-week, Eight-week, Twenty four-week
The salvage/replacement treatments include receiving approved or investigational anti-infective treatment, toxin-neutralizing treatment, other FMT/WMT outside the protocol, and emergency, hospitalization, ICU or surgical treatment due to CDI-related diarrhea, etc.
Immediately, One-week, Two-week, Four-week, Eight-week, Twenty four-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Investigators

  • Principal Investigator: Faming Zhang, PhD, The Second Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2025

Primary Completion (Estimated)

January 31, 2030

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024CMTS0929-CDI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe