NCT00861887

Brief Summary

BACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel, usually associated with previous use of antibiotics. The disease course may be complicated by fulminant disease requiring removal of the colon or by multiple recurrences requiring re-hospitalization. The incidence and severity of Clostridium difficile infection is rising, and it poses an increasing burden on the health system. For example, in one of our previous studies we found that 804 in-patients and 568 out-patients had a positive test for Clostridium difficile toxin at Beaumont Laboratories in 2003. The standard treatment is a 2 week course of Vancomycin or Metronidazole. The clinical response to Metronidazole appears to be declining, and many practicing clinicians prefer Vancomycin as a first-line treatment. The recurrence rate after the treatment is similar for Vancomycin and Metronidazole and is usually in the range of 15-25%, although recent reports noted a recurrence rate up to 50% during outbreaks with a virulent strain. Recently, it has been suggested that a 2 week duration of treatment might not be adequate in clearing the infection. Our HYPOTHESIS is that a prolongation of Vancomycin treatment from 2 weeks to 4 weeks will lead to a decrease rate of recurrent Clostridium Difficile colitis.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 14, 2016

Status Verified

January 1, 2010

Enrollment Period

9 months

First QC Date

March 13, 2009

Last Update Submit

December 13, 2016

Conditions

Clostridium Difficile Colitis

Keywords

Clostridium difficilecolitisrecurrencerelapseVancomycin

Outcome Measures

Primary Outcomes (1)

  • compare the incidence of recurrent Clostridium difficile-associated colitis (CDAD) after a standard 2 week versus a prolonged 4 week course of treatment with Vancomycin

    3 months

Secondary Outcomes (1)

  • assess the response rate to Vancomycin in patients with the first episode of CDAD

    2 weeks

Study Arms (2)

Vancomycin

ACTIVE COMPARATOR

Vancomycin 125 mg every 6 hours x 4 weeks

Drug: Standard VancomycinDrug: Extended Vancomycin

Placebo

PLACEBO COMPARATOR

Vancomycin 125 mg every 6 hours x 2 weeks, followed by placebo every 6 hours x 2 weeks

Drug: Standard Vancomycin

Interventions

Standard VancomycinDRUG

Vancomycin treatment 125 mg po every 6 hours x 2 weeks

PlaceboVancomycin
Extended VancomycinDRUG

Vancomycin 125 mg every 6 hours x 2 weeks

Vancomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First episode of Clostridium difficile colitis, defined by a positive toxin assay plus at least one of the following: diarrhea, toxic megacolon or leukocytosis.

You may not qualify if:

  • previous diagnosis of Clostridium difficile colitis
  • concomitant use of oral Metronidazole, Rifampin, Rifaximin, Nitazoxanide, Sacharromyce boulardii or Lactobacillus spp.
  • age less than 18 years-old
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (2)

  • Zar FA, Bakkanagari SR, Moorthi KM, Davis MB. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis. 2007 Aug 1;45(3):302-7. doi: 10.1086/519265. Epub 2007 Jun 19.

    PMID: 17599306BACKGROUND

  • Pepin J, Alary ME, Valiquette L, Raiche E, Ruel J, Fulop K, Godin D, Bourassa C. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005 Jun 1;40(11):1591-7. doi: 10.1086/430315. Epub 2005 Apr 25.

    PMID: 15889355BACKGROUND

MeSH Terms

Conditions

Enterocolitis, PseudomembranousColitisRecurrence

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

February 1, 2009

Primary Completion

November 1, 2009

Study Completion

January 1, 2010

Last Updated

December 14, 2016

Record last verified: 2010-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)