Fidaxomicin to Prevent Clostridium Difficile Colonization

The Washington University logo

The Washington University

Status and phase

Withdrawn
Phase 4

Conditions

Clostridium Difficile Infection

Treatments

Drug: Placebo
Drug: Fidaxomicin

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01552668
201109037
1U54CK000162 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in preventing C. difficile infection.

Full description

A novel approach to prevent C. difficile infection is to use compounds with activity against C. difficile as primary prophylaxis in high risk patients. Chemoprophylaxis theoretically can prevent C. difficile infection by two mechanisms. It may reduce transmission from asymptomatic C. difficile carriers by reducing the number of spores shed in the stool and prevent replication and subsequent toxin production of the organisms in patients at risk for C. difficile infection.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 18 years old
  • On broad spectrum antimicrobials
  • Anticipated length of stay of > 48 hours after enrollment
  • A non-ICU inpatient

Exclusion criteria

  • Pregnant
  • Expected to die within 7 days
  • Have previously been enrolled in this trial or a trial of an investigational agent to treat CDI, and/or are on monotherapy with an antimicrobial generally considered not to increase the risk of CDI (vanc, macrolides, tetracyclines, trimethoprim/sulfamethoxazole, aminoglycosides, colistin, linezolid, nitrofurantoin, metronidazole)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups, including a placebo group

Fidaxomicin
Experimental group
Description:
Receive 200 mg of fidaxomicin twice daily
Treatment:
Drug: Fidaxomicin
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems