NCT02200328

Brief Summary

The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infection.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 10, 2016

Completed
Last Updated

May 17, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

July 21, 2014

Results QC Date

March 29, 2016

Last Update Submit

April 17, 2017

Conditions

Clostridium Difficile Diarrhea

Keywords

Clostridium difficile infectionDiarrheaFlagylMetronidazole

Outcome Measures

Primary Outcomes (1)

  • The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use.

    30 days

Secondary Outcomes (1)

  • Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin.

    30 days

Study Arms (2)

Metronidazole

EXPERIMENTAL

Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days

Drug: Metronidazole

Placebo

PLACEBO COMPARATOR

Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days

Drug: Placebo

Interventions

MetronidazoleDRUG

Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days

Also known as: Flagyl
Metronidazole
PlaceboDRUG

Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days

Also known as: corn starch pill
Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients \>55
  • Proton Pump inhibitor / Histamine-2 Blocker
  • On broad spectrum antibiotics (Zosyn and/or Ciprofloxacin). These two antibiotics are selected based on current hospital formulary/use
  • Anticipated hospital stay \>48 hours
  • Mental capacity (able to give informed written consent).

You may not qualify if:

  • Admission for CDI
  • Existing diarrhea at admission
  • Passed prophylactic window (\>48 hours on broad spectrum antibiotics)
  • Unable to take PO at the time of evaluation for study entry
  • No more than 14 days of broad spectrum antibiotics anticipated
  • Medications with serious interactions/contraindications to that would be taken together with metronidazole (ex. Warfarin, disulfiram, phenytoin, calcineurin inhibitors)
  • Inflammatory Bowel Disease
  • Admission for colonic bowel surgery or h/o total/Subtotal colectomy)
  • Hospice
  • Mortality expected \<7days
  • Previous CDI in the past 6 months
  • Intensive care admission due to the difficulty of monitoring them
  • Allergy to Metronidazole or other Antibiotics in protocol
  • Patients with neuropathy
  • History of heavy ethyl alcohol intake(greater than 3 drinks daily) or intake in past 24 hours,Solid organ transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Clostridium InfectionsDiarrhea

Interventions

MetronidazoleStarch

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Limitations and Caveats

Early termination: 1. Many patients did not comply with the protocol instructions. 2. Lack of resources to conduct the study. 3. Many patients did not respond to follow up calls.

Results Point of Contact

Title
Dr.Alison Schneider
Organization
Cleveland Clinic Florida
schneia2@ccf.org
9546595646

Study Officials

  • Alison Schneider, M.D.

    Cleveland Clinic Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 25, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 17, 2017

Results First Posted

June 10, 2016

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)