Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

Clostridium Difficile Infection Clinical Trial

Official title:

Efficacy of Prophylactic Oral Vancomycin in Preventing Recurrent Clostridium Difficile Infection in Hospitalized Patients Requiring Antibiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466502
• Other study ID #: 1129396
• Status: Completed
• Phase: Phase 4
• Start date: March 8, 2018
• Est. completion date: February 17, 2022

Study information

• Verified date: November 2023
• Source: University of Nevada, Reno
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections

Intervention

Drug:
• Oral Vancomycin
Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence

Locations

Country	Name	City	State
United States	Renown Regional Medical Center	Reno	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
University of Nevada, Reno	Renown Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Clostridium difficile infection	Diarrheal illness, with at least 3 episodes of watery diarrhea over a 24 hour period and a positive toxin analysis or a positive PCR for Cdiff	During hospitalization or the 12 weeks after therapy
Secondary	Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics	Low inducers: aminoglycosides, fosfomycin, glycopeptides, daptomycin, nitrofurantoin, linezolid, polymyxins, rifamycins, antifolates and/or sulfonamides, tetracyclines, tigecycline; Moderate inducers: penicillins, 1st generation cephalosporins, macrolides, azithromycin, streptogramins; High inducers: carbapenems, 2nd and greater generation cephalosporins, fluoroquinolones, clindamycin	During hospitalization or the 12 weeks after therapy
Secondary	Time between recurrent CDI and the last C diff infection		During hospitalization or the 12 weeks after therapy
Secondary	Rate of recurrence of CDI in immunocompromised patients	HIV, Organ Transplantation, Current Immunosuppressive therapy, Hypogammaglobulinemia or steroids dose more than prednisone 20mg/day for 3 weeks	During hospitalization or the 12 weeks after therapy
Secondary	Rate of recurrence of CDI in patients with a history of the NAP-1 strain		During hospitalization or the 12 weeks after therapy
Secondary	Rate of reported adverse events		During hospitalization or the 12 weeks after therapy
Secondary	Mortality rate		During hospitalization or the 12 weeks after therapy