Personalized Needs in Clostridium Difficile Infections (SPECIFY)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02573571 |
Recruitment Status :
Completed
First Posted : October 12, 2015
Last Update Posted : October 5, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Biologic Markers Clinical Markers | Other: Development of biomarkers |
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 Type : | Observational |
Actual Enrollment : | 150 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Scoring Personalized Needs in Clostridium Difficile Infections for Fidaxomixin Therapy |
Actual Study Start Date : | October 2015 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | October 2017 |
Group/Cohort | Intervention/treatment |
---|---|
Clostridium difficile infection
Patients with Clostridium difficile-associated diarrhea for development of biomarkers
|
Other: Development of biomarkers
Blood sampling
Other Names:
|
- 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
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. No exclusion criteria exist

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573571
Greece | |
5th Department of Internal Medicine, Evangelismos Athens General Hospital | |
Athens, Greece, 10676 | |
1st Department of Internal Medicine, "G.Gennimatas" General hospital | |
Athens, Greece, 11527 | |
1st Department of Internal Medicine, Laikon General Hospital | |
Athens, Greece, 11527 | |
3rd Department of Internal Medicine, Sotiria General Hospital | |
Athens, Greece, 11527 | |
4th Department of Internal Medicine, ATTIKON University Hospital | |
Athens, Greece, 12462 | |
2nd Department of Internal Medicine, Sismanogleion General Hospital | |
Athens, Greece, 15126 | |
1st Department of Internal Medicine, Thriassio General Hospital | |
Magoula, Greece, 10918 | |
2nd Department of Internal Medicine, Thriasio General Hospital | |
Magoula, Greece, 10918 | |
2nd Department of Oncology, Mitera Hospital | |
Maroúsi, Greece, 15123 | |
Infections Unit Tzaneion General Hospital | |
Piraeus, Greece | |
Department of Internal Medicine, Patras University Hospital | |
Pátra, Greece, 36504 | |
1st Department of Internal Medicine, AHEPA University Hospital | |
Thessaloniki, Greece, 54248 |
Principal Investigator: | Athanasios Skoutelis, MD | Evangelismos Athens General Hospital | |
Study Chair: | Evangelos J Giamarellos-Bourboulis, MD, PhD | Attikon Hospital | |
Principal Investigator: | George Chrysos, MD, PhD | Tzaneion Piraeus General Hospital | |
Principal Investigator: | Styliani Symbardi, MD, PhD | Thriassio Elefsis General Hospital | |
Principal Investigator: | Zoi Alexiou, MD, PhD | Thriassio Elefsis General Hospital | |
Principal Investigator: | Kostantinos Syrigos, MD, PhD | Sotiria General Hospital | |
Principal Investigator: | George Daikos, MD, PhD | Laikon Athens General Hospital | |
Principal Investigator: | Panagiotis Gargalianos, MD, PhD | G.Gennimatas Athens General Hospital | |
Principal Investigator: | Malvina Lada, MD, PhD | Sismanogleion General Hospital | |
Principal Investigator: | Charalambos Gogos, MD, PhD | University Hospital of Patras | |
Principal Investigator: | Ilias Athanasiadis, MD, PhD | Mitera General Hospital | |
Principal Investigator: | Symeon Metallidis, MD, PhD | AHEPA Thessaloniki University Hospital |
Responsible Party: | Evangelos J. Giamarellos-Bourboulis, M.D., Associate Professor of Internal Medicine, University of Athens |
ClinicalTrials.gov Identifier: | NCT02573571 |
Other Study ID Numbers: |
CL01 |
First Posted: | October 12, 2015 Key Record Dates |
Last Update Posted: | October 5, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
single nucleotide polymorphisms cytokines microbiome |
Clostridium Infections Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |