Patients at high risk of recurrence due to CDI who require hospitalization and who increase morbidity and mortality from new CDI. MedDRA version: 20.0 Level: LLT Classification code 10072994 Term: Clostridium difficile infection recurrence System Organ Class: 100000004862
Conditions
Interventions
Product Name: Vancomycin hydrochloride
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Vancomicina hidrocloruro
CAS Number: 1404-93-9
Other descriptive name: VANCOMYCIN HYDROCHLORIDE
Concentra
Sponsors
Dra. Julia Origüen Sabater
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age equal to or greater than 18 years. 2. History of infection by Clostrioides difficile (CDI) in the previous 90 days. 3. That requires hospital admission and the need to receive systemic antibiotic treatment (at least 1 day of treatment with at least 1 antimicrobial agent during said admission). 4. Signature of informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Woman of childbearing age (less than 50 years old, except for those who present a gynecological report proving the presence of menopause) and women who are breastfeeding. 2. Allergy to vancomycin 3. Impossibility of complying with the study protocol, including the inability to ingest the capsules or to carry out adequate follow-up, including telephone follow-up or the possibility of transfer to the hospital in less than 48 hours if required. 4. State of extreme severity or life expectancy of less than 30 days. 5. Diagnosis of inflammatory bowel disease or other disease that conditions chronic diarrhea. 6. Criteria for diarrhea (3 or more liquid stools in the last 24 hours) or other clinical and / or microbiological data suggesting CDI at the time of selection or in the previous 3 days. 7. Antibiotic treatment concomitant or within the previous 5 days with oral vancomycin or other drugs active against C. difficile such as metronidazole, fidaxomicin, tigecycline, fusidic acid, rifaximin or nitazoxanide. 8. Have received preventive treatment with oral vancomycin or another active drug against C. difficile in the context of systemic antibiotic therapy in the previous 90 days, including fecal material transplantation. 9. That the patient takes more than 72 hours of systemic antibiotic treatment. If at the time of randomization the patient has been on antibiotic treatment for a longer time, the patient will not be eligible for this study. 10. Simultaneous participation in another clinical trial using investigational drugs. 11. Expected systemic antibiotic therapy time greater than 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of secondary oral vancomycin (OVP) prophylaxis with 125 mg / 6 h is effective compared to placebo in reducing recurrences in patients with a history of Clostrioides Difficile Infection (CDI) and hospitalization in the previous 90 days who require systemic antibiotics during this new hospitalization.;Secondary Objective: Efficacy: - To assess the efficacy of OVP in patients taking antibiotics after an initial episode of CDI, after a first recurrence and two or more recurrences, that is, to compare the efficacy of secondary prophylaxis according to the degree of recurrent disease. - To compare the severity of relapses in both study groups. - To compare the efficacy of secondary OVP according to the type of systemic antibiotic with which the study treatment was administered (vancomycin or placebo). Safety: - To assess the tolerance and safety of OVP (appearance of side effects and difficulty in therapeutic compliance). Exploratory: - To explore whether primary OVP has an impact on reducing the severity of subsequent CDI episodes.;Primary end point(s): Primary efficacy endpoint Incidence of new CDI episodes 60 days after completion of study treatment.;Timepoint(s) of evaluation of this end point: 60 days after the end of study treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy variables 1. Incidence of new episodes of severe CDI or fulminant colitis 60 days after the end of prophylaxis. 2. Incidence of new episodes of diarrhea without definitive diagnosis of CDI 60 days after the end of study treatment. Secondary safety variables 1. Incidence of adverse reaction to study drugs. 2. Percentage of patients who voluntarily abandon study drugs.;Timepoint(s) of evaluation of this end point: 60 days after the end of study treatment. | — |
Countries
Spain
Contacts
Public ContactInvestigador Coordinador
Dr. Rafael San Juan Garrido
Outcome results
None listed