NCT02743234

Brief Summary

Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

2.8 years

First QC Date

April 8, 2016

Last Update Submit

October 14, 2019

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

  • Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment

    Global resolution is defined as combined clinical and microbiological resolution, without need for rescue FMT or colectomy. Clinical resolution is absence of abdominal pain (pain score 0 (no pain), 1 (mild pain), 2 (moderate pain), 3 (severe pain)) and less than 3 bowel movements of Bristol 5 or lower, per day. Microbiological resolution is negative Clostridium difficile test 8 weeks after finishing allocated treatment

    8 weeks

Secondary Outcomes (10)

  • Number of patients with clinical resolution 1 week after primary treatment

    1 week

  • Number of patients with clinical resolution 8 weeks after primary treatment

    8 weeks

  • Number of patients with clinical resolution 26 weeks after primary treatment

    26 weeks

  • Number of patients with microbiological resolution week 1

    1 week

  • Number of patients with microbiological resolution week 8

    8 weeks

  • +5 more secondary outcomes

Study Arms (3)

FMT

EXPERIMENTAL

Fecal microbiota transplantation (FMT) following 4-10 days of vancomycin 125 mg x 4, using cryopreserved feces from a healthy anonymous donor

Other: Fecal microbiota transplantation

Fidaxomicin

ACTIVE COMPARATOR

10 days fidaxomicin 200 mg x 2 daily

Drug: Fidaxomicin

Vancomycin

ACTIVE COMPARATOR

10 days vancomycin 125 x 4 daily

Drug: Vancomycin

Interventions

Fecal microbiota transplantationOTHER

FMT follows 4-10 days of vancomycin 125 mg x 4 daily

FMT
FidaxomicinDRUG

Fidaxomicin 200 mg x 2 daily for 10 days

Fidaxomicin
VancomycinDRUG

Vancomycin 125 mg x 4 daily for 10 days

Vancomycin

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin

You may not qualify if:

  • Pregnancy or breastfeeding
  • Does not speak or understand the Danish language
  • Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin
  • fulminant colitis which contraindicates medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Related Publications (2)

  • Hammeken LH, Baunwall SMD, Dahlerup JF, Hvas CL, Ehlers LH. Health-related quality of life in patients with recurrent Clostridioides difficile infections. Therap Adv Gastroenterol. 2022 Apr 18;15:17562848221078441. doi: 10.1177/17562848221078441. eCollection 2022.

    PMID: 35463939DERIVED

  • Hvas CL, Dahl Jorgensen SM, Jorgensen SP, Storgaard M, Lemming L, Hansen MM, Erikstrup C, Dahlerup JF. Fecal Microbiota Transplantation Is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection. Gastroenterology. 2019 Apr;156(5):1324-1332.e3. doi: 10.1053/j.gastro.2018.12.019. Epub 2019 Jan 2.

    PMID: 30610862DERIVED

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota TransplantationFidaxomicinVancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsMacrolidesLactonesOrganic ChemicalsPolyketidesMacrocyclic CompoundsPolycyclic CompoundsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jens F Dahlerup, MD DrMSc

    Associate professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 19, 2016

Study Start

April 1, 2016

Primary Completion

February 1, 2019

Study Completion

August 31, 2019

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)