Natural History of Clostridioides Difficile Infection

Clostridium Difficile Infection Clinical Trial

Official title:

Clinical, Microbiological and Genetic Factors Associated With Recurrence of Clostridioides Difficile Infection and Development of a Predictive Tool for Recurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801862
• Other study ID #: PI20/01450
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Hospital Universitario de Valme
• Contact: Nicolás Merchante, MD; PhD
• Phone: 955015895
• Email: nicolas.merchante.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age older than 18 years

• New episode of Clostridioides difficile infection, based on IDSA criteria.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Cross Infection
• Health Care Associated Infection
• Infections
• Nosocomial Infection

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario San Juan	Alicante
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario San Cecilio	Granada
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Vega Baja	Orihuela	Alicante
Spain	Hospital Universitario de Puerto Real	Puerto Real	Cadiz
Spain	Hospital Universitario de Valme	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Consorcio Hospital General de Valencia	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Politécnico Universitario La Fe de Valencia	Valencia
Spain	Hospital Marina Baixa	Villajoyosa	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Valme

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. Erratum In: JAC Antimicrob Resist. 2023 Nov 10;5(6):dlad121. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CDI recurrence	Clostridioides difficile recurrence	First 8 weeks after end of therapy
Primary	CDI reinfection	New episode of Clostridioides difficile infection	Between 8 weeks after end of therapy and before 24 weeks
Secondary	Readmission due to CDI infection	New hospitalization related to new Clostridioides difficile infection episode	During 24 weeks after the end of therapy