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NCT01818141

Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin

Completed Phase 4 Results posted Last updated 28 June 2017
What this trial tests

Phase 4 trial testing Vancomycin in Clostridium Difficile Infection in 34 participants. Completed in 15 December 2014.

Timeline
17 October 2012
Primary endpoint
15 December 2014
15 December 2014

Quick facts

Lead sponsorHartford Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment34
Start date17 October 2012
Primary completion15 December 2014
Estimated completion15 December 2014
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Hartford Hospital

Who can join

18 and older, any sex, with Clostridium Difficile Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool Primary · day 10-13

The number and percentage of patients who achieved at least 2 log10 colony forming units (CFU)/g of stool reductions of Clostridium difficile spores from baseline by the end of therapy (days 10-13).

GroupValue95% CI
Fidaxomicin11
Vancomycin6
C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool Primary · day 10-13

The number and percentage of patients who achieved at least 2 log10 CFU/g of stool reductions of Clostridium difficile vegetative cells from baseline by the end of therapy (days 10-13)

GroupValue95% CI
Fidaxomicin4
Vancomycin5

Sponsor's own description

The purpose of this study is to compare number of vegetative cells and spores in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Vancomycin

Trials testing the same drug.

Other recruiting trials for Clostridium Difficile Infection

Currently open trials in the same condition.

Other Hartford Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01818141.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing