Vancomycin for the Treatment of NAAT(+)/Toxin(-) C. Difficile

NCT03827447 | Completed Phase 1 FDA Drug

• 1 other identifier: PRO00033844
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study proposes to:

1. 1.Characterize the impact of oral vancomycin on C. difficile loads after end of treatment compared to a placebo group.
2. 2.Determine the effect of oral vancomycin on structural and functional microbiome changes after end of treatment compared to a placebo group.
3. 3.Characterize the impact of oral vancomycin against a placebo group on the daily frequency of loose stools by the end of treatment.

Conditions

Clostridium Difficile Infection

Keywords

Clostridium Difficile; Metabolomics; Vancomycin; Microbiome

Outcome Measures

Primary Outcomes (2)

• Determine the change in C. difficile loads between the vancomycin vs. placebo group.

  Compare the impact of vancomycin vs placebo on changes in C. difficile load from stool samples collected on Day 1 to end-of-treatment (Day 14) and to Day 28 using quantitative Polymerase Chain Reaction (qPCR).

  Day 1- Day 28

• Determine the long-term persistence of C. difficile from the change in qPCR levels between the vancomycin vs. placebo group

  Establish the long-term persistence of C. difficile by qPCR from stool samples collected at Day 1, 7, 14, 21, 28, and 90 between the vancomycin and placebo group.

  Day 1 - Day 90

Secondary Outcomes (6)

• Characterize the change on structural alterations of the microbiome after end of treatment between the vancomycin vs. placebo groups through 16S rRNA sequencing.

  Pre-treatment, Day 1 - Day 90 past the beginning of treatment

• Measure the change in bile acids in the oral vancomycin vs. placebo groups by mass spectrometry.

  Pre-treatment, Day 1 - Day 90 past the beginning of treatment

• Measure the change in amino acids in the oral vancomycin vs. placebo groups by mass spectrometry.

  Pre-treatment, Day 1 - Day 90 past the beginning of treatment

• Measure the change in sugars in the oral vancomycin vs. placebo groups by mass spectrometry.

  Pre-treatment, Day 1 - Day 90 past the beginning of treatment

• Measure the change in lipids from Day 1 to Day 90 in the oral vancomycin vs. placebo groups by mass spectrometry.

  Pre-treatment, Day 1 - Day 90 past the beginning of treatment

Study Arms (2)

Drug: Vancomycin Group

ACTIVE COMPARATOR

Subjects will receive oral vancomycin capsules by mouth, 125 mg every 6 hours for 14 days.

Drug: Vancomycin Oral Capsule

Drug: Placebo Group

PLACEBO COMPARATOR

Subjects will receive a placebo oral capsule by mouth every 6 hours for 14 days. The placebo oral capsule is manufactured by Study Site's pharmacy to be identical in size, shape, color, appearance and taste as the drug comparator

Drug: Placebo Oral Capsule

Interventions

Vancomycin Oral Capsule DRUG

125 mg capsules every 6 hours for 14 days.

Also known as: Vancocin

Drug: Vancomycin Group

Placebo Oral Capsule DRUG

Gelatin pill manufactured to mimic 125 mg Vancomycin oral capsule

Drug: Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age at time of consent.
• Presence of loose stools triggering clinical C. difficile NAAT/toxin EIA testing.
• Having both C. difficile NAAT (+) and C. difficile toxin EIA (-).
• Admitted outside the hematology-oncology unit.
• Must be willing to keep a study supplied drug diary

You may not qualify if:

• Presence of sepsis. Sepsis will be defined as a Sequential \[Sepsis-related\] Organ Failure Assessment (SOFA) score of 2 points or more as per 2016 definitions.
• Inability to take oral medications.
• Unwillingness or inability to provide written informed consent.
• Has a documented allergy to vancomycin.
• Has a documented life expectancy shorter than treatment course (14 days).
• Unwilling or unable to collect stool samples in the outpatient setting after discharge.
• Diagnosis of C. difficile colitis \[NAAT(+) and toxin EIA(+)\] in the preceding 3 months from enrollment.
• Women known to be pregnant or lactating during the study.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Silvia Munoz-Price, M.D., Ph.D.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: After enrollment, patients will be randomized to treatment with vancomycin 125 mg capsules by mouth every 6 hours for 14 days or to placebo with identical looking capsules for the same length of treatment. Block randomization will be used to assign patients to the treatment or placebo arms. Randomized assignments will be placed in sealed envelopes which will only be handled by the research pharmacist. Clinical providers, research team, and patients will remain blinded to allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be divided into 2 groups, one receiving oral vancomycin and the other placebo.

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: February 1, 2019
• Study Start: July 17, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 30, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)