Clinical trial NCT04801862: Natural History of Clostridioides Difficile Infection
Official title: Clinical, Microbiological and Genetic Factors Associated With Recurrence of Clostridioides Difficile Infection and Development of a Predictive Tool for Recurrence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clostridium Difficile Infection
Health Care Associated Infection
Nosocomial Infection
Keywords: Clostridioides difficile
Clostridium difficile
Nosocomial diarrhea
Health care associated infection
Nosocomial infection
Antimicrobial stewardship
Lead sponsor: Hospital Universitario de Valme
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed of Clostridoides difficile infection

Brief summary: Aim: To investigate if host factors, such as composition and diversity of intestinal microbiota and/or genetic determinants, are associated with a higher risk of recurrence of Clostridioides difficile infection (CDI). To generate a predictive tool based on epidemiological, clinical, genetic and microbiologic variables aimed to identify patients at a higher risk of CDI recurrence in a context of optimized ICD management. Design: Multicenter prospective cohort study. Patients: Older than 18 years patients with CDI diagnosis, made by IDSA criteria, in the participant centers.

Follow-up: A stewarship program aimed to improve CDI management, including early detection of CDI recurrence, will be implemented in the participant centers. Blood samples for genetic testing and stool samples for intestinal microbiome studies will be collected.

Variables and data analysis: The primary outcome variable will be the emergence of CDI recurrence. Potential independent predictors of recurrence, including genetic and microbiological factors, will be assessed. A predictive tool based on independent predictors of recurrence will be built in a development subpopulation. The performance of the model will be assessed by ROC curves, and sensititvity, especificity, as well as negative and positive predictive values will be calculated, both in the development subpopulation and in a validation subset.


Eligibility criteria: Inclusion Criteria:

* Age older than 18 years
* New episode of Clostridioides difficile infection, based on IDSA criteria.

Exclusion Criteria:

- None

Primary outcomes:
measure: CDI recurrence
timeFrame: First 8 weeks after end of therapy
measure: CDI reinfection
timeFrame: Between 8 weeks after end of therapy and before 24 weeks
Secondary outcomes:
measure: Readmission due to CDI infection
timeFrame: During 24 weeks after the end of therapy
Other outcomes:
Locations:
city: Orihuela
country: Spain
facility: Hospital Vega Baja
state: Alicante
city: Villajoyosa
country: Spain
facility: Hospital Marina Baixa
state: Alicante
city: Puerto Real
country: Spain
facility: Hospital Universitario de Puerto Real
state: Cadiz
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Alicante
country: Spain
facility: Hospital Universitario San Juan
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Consorcio Hospital General de Valencia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Politécnico Universitario La Fe de Valencia
Study officials:
References:
citation: Merchante N, Herrero R, Valverde-Fredet MD, Rodriguez-Fernandez M, Pinagorte H, Martinez-Marcos FJ, Gil-Anguita C, Garcia-Lopez M, Tasias Pitarch M, Abril Lopez De Medrano V, Navarrete Lorite MN, Gomez-Ayerbe C, Leon E, Gonzalez-De La Aleja P, Ruiz Castillo A, Aller AI, Rodriguez JC, Ternero Fonseca J, Corzo JE, Naranjo Perez A, Trigo-Rodriguez M, Merino E. Role of previous systemic antibiotic therapy on the probability of recurrence after an initial episode of Clostridioides difficile infection treated with vancomycin. JAC Antimicrob Resist. 2023 Mar 23;5(2):dlad033. doi: 10.1093/jacamr/dlad033. eCollection 2023 Apr.
citation: Merchante N, Chico P, Marquez-Saavedra E, Riera G, Herrero R, Gonzalez-de-la-Aleja P, Aller AI, Rodriguez JC, Rodriguez-Fernandez M, Ramos JM, Trigo-Rodriguez M, Merino E. Impact of COVID19 pandemic on the incidence of health-care associated Clostridioides difficile infection. Anaerobe. 2022 Jun;75:102579. doi: 10.1016/j.anaerobe.2022.102579. Epub 2022 Apr 30.