Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

University of Nevada, Reno

Status and phase: Completed; Phase 4

Conditions: Clostridium Difficile Infection

Treatments: Drug: Oral Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03466502

1129396

Details and patient eligibility

About

This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.

Full description

This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years
2. Previous CDI diagnosis
3. Current admission with a suspected or a confirmed bacterial infection requiring antibiotics

Exclusion criteria

1. Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome)
2. Previous adverse reactions to oral vancomycin
3. Requiring metronidazole during hospitalization
4. Known pregnancy
5. Expected survival <72 hours
6. Patients receiving antibiotics only for surgical prophylaxis
7. Patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 3 patient groups

No oral vancomycin

No Intervention group

Oral vancomycin 125 mg twice daily

Experimental group

Treatment:

Drug: Oral Vancomycin

Oral vancomycin 125 mg daily

Experimental group

Treatment:

Drug: Oral Vancomycin