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

NCT03827447 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-10-20

No results posted yet for this study

Summary

This study proposes to:

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

Interventions

DRUG

Vancomycin Oral Capsule

125 mg capsules every 6 hours for 14 days.

DRUG

Placebo Oral Capsule

Gelatin pill manufactured to mimic 125 mg Vancomycin oral capsule

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Silvia Munoz-Price, M.D., Ph.D. · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2021-06-01
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03827447 on ClinicalTrials.gov