Clostridium Difficile Diarrhea Clinical Trial
Official title:
Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients: A Randomized Clinical Trial
The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infection.
Clostridium Difficile infection or C. Diff (CDI) is an infection that causes severe
diarrhea. Risk factors for this infection include hospitalization, the use of antibiotics,
along with medications that decrease the acid in the stomach. This infection leads to a
disease which is difficult to treat and can cause serious complications including death in
rare cases. This infection also increases medical costs by prolonging hospital stays.
Metronidazole (known by the brand name Flagyl) is an antibiotic that has been available for
decades and has been used to treat this disease. Flagyl is approved by the Food and Drug
Administration for the treatment of C. diff infection. Recent research by the investigators
group has shown that hospitalized patients who took Flagyl had a decreased chance of getting
C. Diff infection. However, high quality studies are needed to better evaluate whether the
investigators can prevent C. Diff infection in high risk patients with the use of Flagyl.
The purpose of this study is to assess if metronidazole prophylaxis is effective in
decreasing the incidence of hospital induced Clostridium Difficile diarrhea among inpatients
at high risk for this infection.
High risk patient population are as defined below: taking a broad spectrum antibiotics
(piperacillin/tazobactam-Zosyn; Ciprofloxacin).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00382304 -
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
|
Phase 2 | |
| Recruiting |
NCT04246151 -
Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients
|
Early Phase 1 | |
| Completed |
NCT03806803 -
Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection
|
Phase 2 | |
| Terminated |
NCT00772954 -
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
|
Phase 1 | |
| Recruiting |
NCT04305769 -
Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
|
Phase 2 | |
| Completed |
NCT00034294 -
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
|
Phase 2 | |
| Terminated |
NCT03793686 -
A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea
|
Phase 1 | |
| Recruiting |
NCT03141775 -
Incidence and Economic Burden of Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS)
|
N/A |