Clinical Trials Logo
  1. Home
  2. Clostridium Difficile
  3. NCT03617172

PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol — PROCLAIM  

Clostridium Difficile Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Trial to Assess The Efficacy and Safety of Misoprostol in The Prevention of Recurrence of Clostridium Difficile Infection in Adults

Clinical Trial Summary

A total of 440 patients meeting enrollment criteria with a primary episode of C. Difficile Infection (CDI) will be enrolled across 3 sites. The total study time period for study procedures followed by clinical monitoring is anticipated to be about 24 months (biomarker assays and other analyses may be completed after the 24 month time period). All participants will receive oral antibiotics for CDI under the care of their physician. After consenting to participate in the study, participants will be randomized to receive either misoprostol (200 mcg po BID) or matching placebo for 14 days. Participants will be monitored for a total time-period of approximately 9 weeks with the goal of monitoring for recurrence of CDI during an 8-week follow-up period from the time that the course of antibiotic treatment is completed. Patients will have blood and stool samples (or rectal swabs if participants are unable to provide a stool sample) collected throughout the study to assess adherence, biomarkers, and to confirm recurrence of CDI (if necessary).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03617172
Study type Interventional
Source Vanderbilt University Medical Center
Contact
Status Terminated
Phase Phase 2
Start date November 26, 2018
Completion date September 22, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT02896244 - AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
Recruiting NCT06071312 - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach Phase 1/Phase 2
Recruiting NCT01973465 - Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis N/A
Terminated NCT01048567 - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly Phase 2
Completed NCT01066221 - Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile N/A
Not yet recruiting NCT03586206 - Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Completed NCT02563106 - A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI Phase 2
Completed NCT02207140 - Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly Phase 0
Completed NCT02857582 - Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile Phase 2
Not yet recruiting NCT01942447 - Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis N/A
Active, not recruiting NCT01703494 - Fecal Transplant for Relapsing C. Difficile Infection Phase 2
Completed NCT01813500 - Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients N/A
Completed NCT01087892 - Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection N/A
Suspended NCT00591357 - Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy Phase 4
Recruiting NCT00377078 - Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile. N/A
Completed NCT02254967 - A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population Phase 4
Terminated NCT01775397 - A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System Phase 4
Recruiting NCT05622721 - REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Completed NCT02437487 - SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) Phase 2
Completed NCT02127814 - Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile N/A