NCT00446355

Completed

Clinical Outcomes of Patients With Clostridium Difficile Ass...

University of Pittsburgh Source

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Other study identifiers

Sponsor study identifier

PRO07010069

Study Type

observational

Estimated enrollment

1,000

Locations

1 country

Sites

1

Timeline

Study Start

February 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2009

Actual (reported)

Study Completion

April 2009

Actual (reported)

Brief Summary

The purpose of the study is to establish the clinical disease outcomes and features of CDAD associated with variant tcdC genotypes. Two hypotheses are to be tested in this study:

1.Severe CDAD and tcdC truncation:
2.Disease in low risk populations (patients never exposed to health care facilities and/or patients who never received antibiotics) of any severity is attributable to strains of C. difficile with severe tcdC truncation.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 1,000 participants
Study completion date: April 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 8, 2007
Actual (reported)
First Posted
March 12, 2007
Actual (reported)
Primary Completion
April 2009
Actual (reported)
Study Completion
April 2009
Actual (reported)

Last Updated: April 14, 2009
Status Verified: April 2009
Last Update Submitted: April 12, 2009

Conditions

Clostridium Infections

Keywords

C diffantibiotics

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

CDAD confirmed

You may qualify if:

All patients who have confirmed CDAD, confirmed by testing at UPMC's clinical microbiology lab in March 1, 2001- December 31, 2005 for C. difficile by stool toxin test with subsequent positive culture for the organism from inpatients/outpatients at UPMC Presbyterian-Montefiore, from WPIC inpatient units, from ER visits at the Presbyterian University Hospital emergency department, and from clinics closely affiliated with UPMC Presbyterian (medical and surgical clinics in Falk Clinic, the 9 South Montefiore internal medicine clinic, the geriatrics clinic in Montefiore, and the digestive disorders center (GI clinic on 3rd floor of PUH).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Pittsburgh
Otherlead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

Scott Curry, MD
University of Pittsburgh
PRINCIPAL INVESTIGATOR
Lee Harrison, MD
University of Pittsburgh
STUDY DIRECTOR

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER

Study Record Dates

First Submitted

March 8, 2007

First Posted

March 12, 2007

Study Start

February 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2009

Actual (reported)

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Unknown

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NCT00269399

A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

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NCT00468728

PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Phase 3Completed

Study Completion

April 2009

Actual (reported)

Last Updated

April 14, 2009

Record last verified: 2009-04

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00446355
Data provider: ClinicalTrials.gov
Source updated: 2009-04-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:43 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations