NCT02057198 (C-Diff) is a Phase 4 clinical trial of Fidaxomicin in C. Difficile, sponsored by Duke University.

Who is sponsoring NCT02057198?

NCT02057198 is sponsored by Duke University.

What drugs are being tested in NCT02057198?

Interventions in NCT02057198: Fidaxomicin, Metronidazole, Vancomycin.

What condition does NCT02057198 study?

NCT02057198 studies C. Difficile, Diarrhea, Enterocolitis.

Is NCT02057198 still recruiting?

NCT02057198 is currently completed. Last updated 2 October 2019.

Are results published for NCT02057198?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-10-02 · How we verify

NCT02057198: C-Diff

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Impact of Oral Antibiotic Treatment on C. Difficile

Completed Phase 4 Results posted Last updated 2 October 2019

What this trial tests

Phase 4 trial testing Fidaxomicin in C. Difficile in 33 participants. Completed in 27 June 2017.

Timeline

10 June 2014

Primary endpoint
27 June 2017

27 June 2017

Quick facts

Lead sponsor	Duke University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	10 June 2014
Primary completion	27 June 2017
Estimated completion	27 June 2017
Sites	1 location across United States

Drugs / interventions tested

Fidaxomicin (FIDAXOMICIN) — full drug profile →
Metronidazole (METRONIDAZOLE) — full drug profile →
Vancomycin (vancomycin) — full drug profile →

Conditions studied

C. Difficile — all drugs for C. Difficile →
Diarrhea — all drugs for Diarrhea →
Enterocolitis — all drugs for Enterocolitis →

Sponsor

Duke University

Who can join

18 and older, any sex, with C. Difficile or Diarrhea. 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.

Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group. Primary · Days 0, 3, 7 and 14.

Rodac plates were used to take environmental samples from 5 different sites within each patient's hospital room (bedrail, overbed table, sink, toilet seat, bathroom floor). Each Rodac plate samples a surface area of \~25 cm2. 5 replicates were taken for each site and repeated on days 0, 3, 7, and 14. Median total colony counts are reported for each treatment group. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects

Day 0

Group	Value	95% CI
Fidaxomicin	56	0 – 158
Metronidazole	33	23 – 43
Vancomycin	149	0 – 227

Day 3

Group	Value	95% CI
Fidaxomicin	7	4 – 9
Metronidazole	53	17 – 92
Vancomycin	24	5 – 43

Day 7

Group	Value	95% CI
Fidaxomicin	0	0 – 0
Metronidazole	15	12 – 18
Vancomycin	0	0 – 0

Day 14

Group	Value	95% CI
Fidaxomicin	0	0 – 0
Metronidazole	0	0 – 0
Vancomycin	0	0 – 0

Total Environmental Contamination According to Antibiotic Treatment Group Secondary · Days 0, 3, 7, and 14

In addition to total colony counts over time, the investigators also assessed the proportion of positive cultures over time (from the 5 replicate Rodac plate samplings repeated at each of 5 sites within each patient room: bedrail, overbed table, sink, toilet seat and bathroom floor). The cumulative proportion of positive cultures (including days 0, 3, 7, 14) is reported according to each treatment group.

Group	Value	95% CI
Fidaxomicin	13.4
Metronidazole	18.6
Vancomycin	7.6

Molecular Relatedness of Isolates Secondary · Days 0-14

When sufficient growth was available to permit sub-culture and ribotyping, we conducted ribotyping of each patient's stool C. difficile isolate for comparison to isolates from the same patient's hospital environment. Reported is the total percent of hospital room environmental isolates that match the ribotyping of the associated patient's stool sample (there is no averaging).

Group	Value	95% CI
Fidaxomicin	68.1
Metronidazole	80.0
Vancomycin	77.8

C. Difficile Shedding in Stool Over Time Secondary · Days 0, 3, 7, 14

C. difficile was isolated and serially diluted to permit colony counts (CFU/g stool) over time for each patient.

Day 0

Group	Value	95% CI
Fidaxomicin	815940	± 949503
Metronidazole	2233564	± 3845558
Vancomycin	35340	± 41612

Day 3

Group	Value	95% CI
Fidaxomicin	72200	± 156429
Metronidazole	1200	± 283
Vancomycin	400	± 693

Day 7

Group	Value	95% CI
Fidaxomicin	0	± 0
Metronidazole	0	± 0
Vancomycin	0	± 0

Day 14

Group	Value	95% CI
Fidaxomicin	0	± 0
Metronidazole	0	± 0
Vancomycin	0	± 0

Count of Stool Specimens From Patients That Are Positive for C. Difficile Secondary · Days 0, 3, 7, 14

Count of stool cultures positive for C. difficile at each time point

Day 0

Group	Value	95% CI
Fidaxomicin	20
Metronidazole	21
Vancomycin	17

Day 3

Group	Value	95% CI
Fidaxomicin	6
Metronidazole	3
Vancomycin	2

Day 7

Group	Value	95% CI
Fidaxomicin	0
Metronidazole	0
Vancomycin	0

Day 14

Group	Value	95% CI
Fidaxomicin	0
Metronidazole	0
Vancomycin	0

Percentage of Stool Specimens From Patients That Are Positive for C. Difficile Secondary · Days 0, 3, 7, 14

Percentage of stool cultures positive for C. difficile at each time point

Day 0

Group	Value	95% CI
Fidaxomicin	100
Metronidazole	95.5
Vancomycin	85

Day 3

Group	Value	95% CI
Fidaxomicin	60
Metronidazole	75
Vancomycin	33

Day 7

Group	Value	95% CI
Fidaxomicin	0
Metronidazole	0
Vancomycin	0

Day 14

Group	Value	95% CI
Fidaxomicin	0
Metronidazole	0
Vancomycin	0

Sponsor's own description

The overall aim is to characterize and to compare the extent and quantity of C. difficile stool shedding, perianal colonization and environmental contamination in patients who received oral fidaxomicin, oral metronidazole, or oral vancomycin. This is a prospective, randomized, microbiologic and molecular, study of environmental contamination from patients with proven C. difficile associated diarrhea (CDAD).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Impact of Oral Metronidazole, Vancomycin, and Fidaxomicin on Host Shedding and Environmental Contamination With Clostridioides difficile.
Turner NA, Warren BG, Gergen-Teague MF, Addison RM, et al · · 2022 · cited 8× · PMID 34017999 · DOI 10.1093/cid/ciab473

Verify or expand the search:

Other trials of Fidaxomicin

Trials testing the same drug.

NCT07328971 — Vancomycin Taper to Prevent Recurrent Clostridioides Difficile · Phase 3 · not yet recruiting
NCT05201079 — Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fida · Phase 3 · completed
NCT04070352 — Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI) · withdrawn
NCT02692651 — A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections · Phase 4 · completed
NCT02667418 — Optimal Treatment for Recurrent Clostridium Difficile · Phase 4 · terminated

Other Duke University trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02057198 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 2 October 2019

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/NCT02057198.

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

NCT02057198: C-Diff

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Fidaxomicin

Other Duke University trials

Verify against primary sources