Treatment for Clostridium Infections

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis, MN
Clostridium Infections+1 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a specific type of bacteria may help prevent a common infection.

See full description

Eligible Conditions

  • Clostridium Infections
  • Clostridium Difficile Infection (CDI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Clostridium Infections

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 9 secondary outcomes, and 1 other outcome in patients with Clostridium Infections. Measurement will happen over the course of Within 56 days of randomization.

56 days from randomization
Quality of Life
Day 56
Death
Definite recurrent CDI
Diarrhea that is negative for C. difficile by EIA toxin test and PCR
Diarrhea that is negative for C. difficile by EIA toxin testing but positive by PCR
Possible recurrent CDI
Recurrent CDI (definite or probable) or death
Month 6
Adverse and Serious Adverse Events
Multiple related symptoms
Number of CDI recurrences
Recurrent CDI (definite or possible), or death

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Clostridium Infections

Trial Design

2 Treatment Groups

1
1 of 2
2
1 of 2
Active Control
Non-Treatment Group

This trial requires 390 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

1
Drug
Fecal Microbiota Therapy (FMT)
2
Drug
Placebo

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 56 days of randomization
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within 56 days of randomization for reporting.

Closest Location

Minneapolis VA Health Care System, Minneapolis, MN - Minneapolis, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Clostridium Infections or the other condition listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Within the enrollment window: 2 days after completion of antimicrobial therapy for CDI (to allow for a washout period) to 14 days after completion of therapy or 30 days after the onset of CDI whichever is later.
One or more episodes recurrent CDI (defined as > 3 loose/watery stools/24h for 2 consecutive days with CDI treatment, and not explained by another diagnosis PLUS laboratory confirmation of C. difficile; or ileus, or toxic megacolon PLUS laboratory confirmation of C. difficile, occurring within 90 days of a prior CDI episode with similar symptoms and laboratory confirmation)
Resolution or improvement of symptoms from most recent CDI episode, defined as no longer meeting the clinical definition for CDI for a 48 hour period during treatment, including not meeting the definition again after an initial improvement
Enrolled in a VHA facility
Able and willing to provide informed consent
Age 18 years

Patient Q&A Section

Ask a question about the study

Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Clostridium Infections by sharing your contact details with the study coordinator.