Clostridium Difficile InfectionNCT04801862
Natural History of Clostridioides Difficile Infection
An observational study of Clostridium Difficile Infection and Health Care Associated Infection, run by Hospital Universitario de Valme at 15 sites in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection, Health Care Associated Infection, Nosocomial Infection
- How many people
- 750 participants
- Where
- 15 sitesSpain
- Study dates
- 1 Jan 2021to 31 Dec 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed of Clostridoides difficile infection
Who may be able to join
- Age older than 18 years
- New episode of Clostridioides difficile infection, based on IDSA criteria.
Who cannot join
- None
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Spain15 sites, 12 recruiting
- Recruiting
Hospital Universitario San Juan
Alicante, Alicante
Francisco Jover
Francisco Jover
- Recruiting
Hospital General Universitario de Alicante
Alicante
Esperanza Merino
Juan Carlos Rodríguez
- Terminated
Hospital Universitario Reina Sofía
Córdoba
- Recruiting
Hospital Universitario San Cecilio
Granada, Granada
Emilio Guirao
Emilio Guirao
- Recruiting
Hospital Juan Ramón Jiménez
Huelva, Huelva
Francisco J. Martínez Marcos
Francisco J. Martínez Marcos
- Withdrawn
Hospital Regional Universitario de Málaga
Málaga, Málaga
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, Málaga
Cristina Gómez Ayerbe
Cristina Gómez Ayerbe
- Recruiting
Hospital Vega Baja
Orihuela, Alicante
María García
María García
- Terminated
Hospital Universitario de Puerto Real
Puerto Real, Cadiz
- Recruiting
Hospital Universitario de Valme
Seville
Rocío Herrero, mariar.herrero@juntadeandalucia.es
Nicolás Merchante
- Recruiting
Hospital Universitario Virgen Macarena
Seville
Virginia Palomo
Miguel Nicolás Navarrete
- Recruiting
Consorcio Hospital General de Valencia
Valencia, Valencia
Vicente Abril
Vicente Abril
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, Valencia
Rosa Oltra
Rosa Oltra
- Recruiting
Hospital Politécnico Universitario La Fe de Valencia
Valencia, Valencia
Maria Tasias
Maria Tasias
- Recruiting
Hospital Marina Baixa
Villajoyosa, Alicante
Concepción Gil
Concepción Gil
About this study
Official title: Clinical, Microbiological and Genetic Factors Associated With Recurrence of Clostridioides Difficile Infection and Development of a Predictive Tool for Recurrence
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.
- Keywords
- Clostridioides difficile, Clostridium difficile, Nosocomial diarrhea, Health care associated infection, Nosocomial infection, Antimicrobial stewardship
- Medical subject headings
- Clostridium Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed of C.difficile infection | Open cohort of consecutive patients diagnosed of Clostridioides difficile infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDI recurrence
Clostridioides difficile recurrence
Measured: First 8 weeks after end of therapy
CDI reinfection
New episode of Clostridioides difficile infection
Measured: Between 8 weeks after end of therapy and before 24 weeks
Secondary outcomes (1)
Readmission due to CDI infection
New hospitalization related to new Clostridioides difficile infection episode
Measured: During 24 weeks after the end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Valme
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolás Merchante, Hospital Universitario de Valme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801862
- Sponsor's protocol ID
- PI20/01450
- Status last verified
- Sep 2026
- First submitted
- 12 Mar 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36968953Merchante 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.
PubMed 35500744Ventero MP, Valverde-Fredet MD, Merino E, Herrero R, Germak IT, Rodriguez-Fernandez M, Ramos-Rincon JM, Garcia M, Delgado-Sanchez E, Navarrete-Lorite MN, Gil C, Tasias M, Caston JJ, Vinuesa-Garcia D, Gomez-Ayerbe C, Marcos FJM, Merchante N, Rodriguez JC. Antimicrobial Susceptibility of Clostridioides difficile in Spain: Multicenter Retrospective Cohort Study. Antibiotics (Basel). 2026 Feb 2;15(2):145. doi: 10.3390/antibiotics15020145.
PubMed 41750443Rodriguez-Fernandez M, Herrero R, Gonzalez-De-La-Aleja P, Valverde-Fredet MD, Ventero MP, Trigo-Rodriguez M, Giner L, Aller-Garcia AI, Pinargote-Celorio H, Espindola-Gomez R, Parra M, Martinez Perez-Crespo P, Ramos-Rincon JM, Fernandez-Pevida A, Lanz-Garcia J, Leon E, Valiente-De-Santis L, Corzo JE, Rodriguez JC, Merino E, Merchante N. Clinical Impact of Implementing a Specific Clinical Pathway for the Management of Clostridioides difficile Infection. Infect Dis Ther. 2026 Jan;15(1):85-100. doi: 10.1007/s40121-025-01261-9. Epub 2025 Nov 7.
PubMed 41201562
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Microbiological and Genetic Factors Associated With Recurrence of Clostridioides Difficile Infection and Development of a Predictive Tool for Recurrence
- ClinicalTrials.gov ID
- NCT04801862
- Acronym / sponsor ID
- PI20/01450
- Keywords
- Clostridioides difficile, Clostridium difficile, Nosocomial diarrhea, Health care associated infection, Nosocomial infection, Antimicrobial stewardship
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Hospital Universitario de ValmeUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed of C.difficile infection | – | –Open cohort of consecutive patients diagnosed of Clostridioides difficile infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed of Clostridoides difficile infection
Key inclusion criteria (2 listed)
- Age older than 18 years
- New episode of Clostridioides difficile infection, based on IDSA criteria.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CDI recurrence
Time frame: First 8 weeks after end of therapy
Clostridioides difficile recurrence
CDI reinfection
Time frame: Between 8 weeks after end of therapy and before 24 weeks
New episode of Clostridioides difficile infection
1 secondary outcome
Readmission due to CDI infection
Time frame: During 24 weeks after the end of therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 36968953Merchante 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.
- Background: PubMed 35500744Merchante 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.
- Derived from this study: PubMed 41750443Ventero MP, Valverde-Fredet MD, Merino E, Herrero R, Germak IT, Rodriguez-Fernandez M, Ramos-Rincon JM, Garcia M, Delgado-Sanchez E, Navarrete-Lorite MN, Gil C, Tasias M, Caston JJ, Vinuesa-Garcia D, Gomez-Ayerbe C, Marcos FJM, Merchante N, Rodriguez JC. Antimicrobial Susceptibility of Clostridioides difficile in Spain: Multicenter Retrospective Cohort Study. Antibiotics (Basel). 2026 Feb 2;15(2):145. doi: 10.3390/antibiotics15020145.
- Derived from this study: PubMed 41201562Rodriguez-Fernandez M, Herrero R, Gonzalez-De-La-Aleja P, Valverde-Fredet MD, Ventero MP, Trigo-Rodriguez M, Giner L, Aller-Garcia AI, Pinargote-Celorio H, Espindola-Gomez R, Parra M, Martinez Perez-Crespo P, Ramos-Rincon JM, Fernandez-Pevida A, Lanz-Garcia J, Leon E, Valiente-De-Santis L, Corzo JE, Rodriguez JC, Merino E, Merchante N. Clinical Impact of Implementing a Specific Clinical Pathway for the Management of Clostridioides difficile Infection. Infect Dis Ther. 2026 Jan;15(1):85-100. doi: 10.1007/s40121-025-01261-9. Epub 2025 Nov 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection and Health Care Associated Infection, run by Hospital Universitario de Valme at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolás Merchante, MD; PhD (955015895, nicolas.merchante.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDI recurrence (time frame: First 8 weeks after end of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04801862, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.