Biologic MarkersSPECIFYNCT02573571
Personalized Needs in Clostridium Difficile Infections
An observational study of Biologic Markers and Clinical Markers, run by University of Athens at 12 sites in Greece.
Trial summary
To develop a score that can predict early from diagnosis of Clostridium difficile infection (CDI) the risk for relapse and of unfavorable outcome. This score can be used in the future to identify patients will benefit from fidaxomicin treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biologic Markers, Clinical Markers
- What is being tested?
- Development of biomarkers
- How many people
- 150 participants
- Where
- 12 sitesGreece
- Study dates
- Oct 2015to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with Clostridium difficile-associated diarrhea
Who may be able to join
- Age equal to or more than 18 years
- Both genders
- Diarrhea defined as at least 3 episodes of unformed stools in the last 24 hours according to the Bristol stool chart
- Presence of C.difficile in stool. This is defined as any stool sample positive for the presence of glutamate dehydrogenase (GDH) and for the presence of toxin A and/or B.
Who cannot join
- 1. No exclusion criteria exist
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Greece12 sites
5th Department of Internal Medicine, Evangelismos Athens General Hospital
Athens, 10676
1st Department of Internal Medicine, "G.Gennimatas" General hospital
Athens, 11527
1st Department of Internal Medicine, Laikon General Hospital
Athens, 11527
3rd Department of Internal Medicine, Sotiria General Hospital
Athens, 11527
4th Department of Internal Medicine, ATTIKON University Hospital
Athens, 12462
2nd Department of Internal Medicine, Sismanogleion General Hospital
Athens, 15126
1st Department of Internal Medicine, Thriassio General Hospital
Magoula, 10918
2nd Department of Internal Medicine, Thriasio General Hospital
Magoula, 10918
2nd Department of Oncology, Mitera Hospital
Marousi, 15123
Department of Internal Medicine, Patras University Hospital
Pátrai, 36504
Infections Unit Tzaneion General Hospital
Piraeus
1st Department of Internal Medicine, AHEPA University Hospital
Thessaloniki, 54248
About this study
Official title: Scoring Personalized Needs in Clostridium Difficile Infections for Fidaxomixin Therapy
To develop a score that can predict early from diagnosis of Clostridium difficile infection (CDI) the risk for relapse and of unfavorable outcome. This score can be used in the future to identify patients will benefit from fidaxomicin treatment.
Read the detailed description
Medical world is nowadays witnessing a sudden increase of the incidence of infections by Clostridium difficile (DCI). This is due in part to the prolongation of survival of patients with major comorbidities like solid tumor malignancies and lymphomas but also to the widespread intake of proton pump inhibitors and of wide-spectrum antimicrobials. It is highly probable that isolates of C.define causing this pandemic are genetically different than isolates of the same species predominating 20 years ago. This hypothesis is developed based on data of the epidemiology of CDI: in old times administration of clindamycin and ampicillin were the main drivers of CDI; recent studies report fluoroquinolones, 2nd and 3rd generation cephalosporins and even vancomycin (i.e. a drug of choice for CDI) to be linked with the development of CDI.
One major hurdle in management of CDI is relapse; the risk of relapse is reported as 15-20% after the first episode; however it is geometrically increased to even 60-80% after the second episode. As a consequence, management of CDI becomes a major health problem.
Fidaxomicin is a novel compound active against species of C.dificille. Results of two recent double-blind, randomized, large scale clinical studies have shown that oral treatment for 10 days with fidaxomicin 200mg bid was non-inferior to oral treatment with vancomycin 125mg q6h. However, the risk of relapse after treatment with vancomycin was close to 25% and with fidaxomicin close to 15%. This difference was statistically significant in both trials outscoring the superiority of fidaxomicin over vancomycin for the management of CDI. Moreover, meta-analysis has shown a significant reduction in mortality by fidaxomicin.
Despite proven superiority, prescription of fidaxomicin is limited to few cases mostly due to high cost. In many countries prescription is restricted to cases of relapsing CDI. Clinical feeling coming both from post-marketing experience as well as from published evidence supports the use of fidaxomicin for cases with risk of death and overt risk of relapse. However, molecular analysis of the C.difficile pathogen cannot be used as a tool for the prediction of relapse since in relapse cases pathogens carry less than 2 single nucleotide variants of the initial isolate. SPECIFY is aiming to develop a score using both clinical and genetic and biomarker data that can efficiently discriminate patients at risk of severe CDI and at risk of relapse of CDI. This score can become in future a tool to discriminate patients at need for treatment with fidaxomicin instead of traditional treatment with metronidazole/vancomycin.
- Conditions
- Biologic Markers, Clinical Markers
- Being tested
- Development of biomarkers
- Keywords
- single nucleotide polymorphisms, cytokines, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development of biomarkersOther
Also called Single nucleotide polymorphisms, Serum cytokines
Blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Clostridium difficile infection | Patients with Clostridium difficile-associated diarrhea for development of biomarkers Receives: Other: Development of biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definition of prognostic biomarker
Patients with positive score and unfavorable outcome. Unfavorable outcome is defined as at least one of the following: a) number of patients with severe infection at disease onset; b) number of patients who progress into severe infection; c) number of patients with disease recurrence; and d) number of patients who die
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Biologic MarkersStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Sepsis Study Group
- Responsible party
- Principal investigator, Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens
- Investigators
- Athanasios Skoutelis, MD, Principal investigator, Evangelismos Athens General HospitalEvangelos J Giamarellos-Bourboulis, MD, PhD, Study chair, Attikon HospitalGeorge Chrysos, MD, PhD, Principal investigator, Tzaneion Piraeus General HospitalStyliani Symbardi, MD, PhD, Principal investigator, Thriassio Elefsis General HospitalZoi Alexiou, MD, PhD, Principal investigator, Thriassio Elefsis General HospitalKostantinos Syrigos, MD, PhD, Principal investigator, Sotiria General HospitalGeorge Daikos, MD, PhD, Principal investigator, Laikon Athens General HospitalPanagiotis Gargalianos, MD, PhD, Principal investigator, G.Gennimatas Athens General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573571
- Sponsor's protocol ID
- CL01
- Acronym
- SPECIFY
- Status last verified
- Oct 2017
- First submitted
- 8 Oct 2015
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rao K, Erb-Downward JR, Walk ST, Micic D, Falkowski N, Santhosh K, Mogle JA, Ring C, Young VB, Huffnagle GB, Aronoff DM. The systemic inflammatory response to Clostridium difficile infection. PLoS One. 2014 Mar 18;9(3):e92578. doi: 10.1371/journal.pone.0092578. eCollection 2014.
PubMed 24643077Psarrakis C, Tziolos NR, Matzarakis V, Kumar V, Stylianakis E, Sidiropoulou C, Tasouli E, Iliopoulou K, Samarkos M, Metallidis S, Georgiadou S, Akinosoglou K, Bolanou A, Hatziagelaki E, Kostaki A, Panagopoulos P, Toutouzas K, Milionis H, Adamis G, Poulakou G, Lada M, Skoutelis A, Alexiou Z, Symbardi S, Chrysos G, Netea MG, Giamarellos-Bourboulis EJ. A randomized controlled trial of precision bezlotoxumab treatment for Clostridioides difficile infection. Cell Rep Med. 2026 Jan 20;7(1):102533. doi: 10.1016/j.xcrm.2025.102533. Epub 2026 Jan 2.
PubMed 41483804Tziolos RN, Psarrakis C, Koufargyris P, Chrysos G, Sympardi S, Iliopoulou K, Giamarellos-Bourboulis EJ. Pancreatic Stone Protein as an Early Prognostic Biomarker of Outcome in Clostridioides Difficile Infection. Shock. 2026 Sep 1;66(3):787-791. doi: 10.1097/SHK.0000000000002759. Epub 2025 Nov 18.
PubMed 41427863
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scoring Personalized Needs in Clostridium Difficile Infections for Fidaxomixin Therapy
- ClinicalTrials.gov ID
- NCT02573571
- Acronym / sponsor ID
- SPECIFY / CL01
- Conditions
- Biologic Markers, Clinical Markers
- Keywords
- single nucleotide polymorphisms, cytokines, microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Collaborators
- Hellenic Sepsis Study Group
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 12 Oct 2015 (estimated)
- 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.
To develop a score that can predict early from diagnosis of Clostridium difficile infection (CDI) the risk for relapse and of unfavorable outcome. This score can be used in the future to identify patients will benefit from fidaxomicin treatment.
Detailed description
Medical world is nowadays witnessing a sudden increase of the incidence of infections by Clostridium difficile (DCI). This is due in part to the prolongation of survival of patients with major comorbidities like solid tumor malignancies and lymphomas but also to the widespread intake of proton pump inhibitors and of wide-spectrum antimicrobials. It is highly probable that isolates of C.define causing this pandemic are genetically different than isolates of the same species predominating 20 years ago. This hypothesis is developed based on data of the epidemiology of CDI: in old times administration of clindamycin and ampicillin were the main drivers of CDI; recent studies report fluoroquinolones, 2nd and 3rd generation cephalosporins and even vancomycin (i.e. a drug of choice for CDI) to be linked with the development of CDI.
One major hurdle in management of CDI is relapse; the risk of relapse is reported as 15-20% after the first episode; however it is geometrically increased to even 60-80% after the second episode. As a consequence, management of CDI becomes a major health problem.
Fidaxomicin is a novel compound active against species of C.dificille. Results of two recent double-blind, randomized, large scale clinical studies have shown that oral treatment for 10 days with fidaxomicin 200mg bid was non-inferior to oral treatment with vancomycin 125mg q6h. However, the risk of relapse after treatment with vancomycin was close to 25% and with fidaxomicin close to 15%. This difference was statistically significant in both trials outscoring the superiority of fidaxomicin over vancomycin for the management of CDI. Moreover, meta-analysis has shown a significant reduction in mortality by fidaxomicin.
Despite proven superiority, prescription of fidaxomicin is limited to few cases mostly due to high cost. In many countries prescription is restricted to cases of relapsing CDI. Clinical feeling coming both from post-marketing experience as well as from published evidence supports the use of fidaxomicin for cases with risk of death and overt risk of relapse. However, molecular analysis of the C.difficile pathogen cannot be used as a tool for the prediction of relapse since in relapse cases pathogens carry less than 2 single nucleotide variants of the initial isolate. SPECIFY is aiming to develop a score using both clinical and genetic and biomarker data that can efficiently discriminate patients at risk of severe CDI and at risk of relapse of CDI. This score can become in future a tool to discriminate patients at need for treatment with fidaxomicin instead of traditional treatment with metronidazole/vancomycin.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clostridium difficile infection | – | Other: Development of biomarkersPatients with Clostridium difficile-associated diarrhea for development of biomarkers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Clostridium difficile-associated diarrhea
Key inclusion criteria (4 listed)
- Age equal to or more than 18 years
- Both genders
- Diarrhea defined as at least 3 episodes of unformed stools in the last 24 hours according to the Bristol stool chart
- Presence of C.difficile in stool. This is defined as any stool sample positive for the presence of glutamate dehydrogenase (GDH) and for the presence of toxin A and/or B.
Key exclusion criteria (1 listed)
- 1. No exclusion criteria exist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Development of biomarkersAlso: Single nucleotide polymorphisms, Serum cytokinesBlood sampling | Other | Clostridium difficile infection |
Primary outcome
Definition of prognostic biomarker
Time frame: 12 months
Patients with positive score and unfavorable outcome. Unfavorable outcome is defined as at least one of the following: a) number of patients with severe infection at disease onset; b) number of patients who progress into severe infection; c) number of patients with disease recurrence; and d) number of patients who die
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Background: PubMed 24643077Rao K, Erb-Downward JR, Walk ST, Micic D, Falkowski N, Santhosh K, Mogle JA, Ring C, Young VB, Huffnagle GB, Aronoff DM. The systemic inflammatory response to Clostridium difficile infection. PLoS One. 2014 Mar 18;9(3):e92578. doi: 10.1371/journal.pone.0092578. eCollection 2014.
- Derived from this study: PubMed 41483804Psarrakis C, Tziolos NR, Matzarakis V, Kumar V, Stylianakis E, Sidiropoulou C, Tasouli E, Iliopoulou K, Samarkos M, Metallidis S, Georgiadou S, Akinosoglou K, Bolanou A, Hatziagelaki E, Kostaki A, Panagopoulos P, Toutouzas K, Milionis H, Adamis G, Poulakou G, Lada M, Skoutelis A, Alexiou Z, Symbardi S, Chrysos G, Netea MG, Giamarellos-Bourboulis EJ. A randomized controlled trial of precision bezlotoxumab treatment for Clostridioides difficile infection. Cell Rep Med. 2026 Jan 20;7(1):102533. doi: 10.1016/j.xcrm.2025.102533. Epub 2026 Jan 2.
- Derived from this study: PubMed 41427863Tziolos RN, Psarrakis C, Koufargyris P, Chrysos G, Sympardi S, Iliopoulou K, Giamarellos-Bourboulis EJ. Pancreatic Stone Protein as an Early Prognostic Biomarker of Outcome in Clostridioides Difficile Infection. Shock. 2026 Sep 1;66(3):787-791. doi: 10.1097/SHK.0000000000002759. Epub 2025 Nov 18.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Athanasios Skoutelis, MD principal investigator
Evangelismos Athens General Hospital
Evangelos J Giamarellos-Bourboulis, MD, PhD study chair
Attikon Hospital
George Chrysos, MD, PhD principal investigator
Tzaneion Piraeus General Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biologic Markers and Clinical Markers, run by University of Athens at 12 sites in Greece.
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 4 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: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definition of prognostic biomarker (time frame: 12 months). 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 NCT02573571, which also lists 3 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 5 Oct 2017.