Personalized Needs in Clostridium Difficile Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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

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Biologic Markers Clinical Markers

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Clostridium difficile infection

Patients with Clostridium difficile-associated diarrhea for development of biomarkers

Development of biomarkers

Intervention Type OTHER

Blood sampling

Interventions

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Development of biomarkers

Blood sampling

Intervention Type OTHER

Other Intervention Names

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Single nucleotide polymorphisms Serum cytokines

Eligibility Criteria

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Inclusion Criteria

1. Age equal to or more than 18 years
2. Both genders
3. Diarrhea defined as at least 3 episodes of unformed stools in the last 24 hours according to the Bristol stool chart
4. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Evangelos J. Giamarellos-Bourboulis, M.D.

Associate Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Role: PRINCIPAL_INVESTIGATOR

AHEPA Thessaloniki University Hospital

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

PMID: 24643077 (View on PubMed)

Other Identifiers

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CL01

Identifier Type: -

Identifier Source: org_study_id

Personalized Needs in Clostridium Difficile Infections

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Clostridium difficile infection

Development of biomarkers

Interventions

Development of biomarkers

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Sponsors

Hellenic Sepsis Study Group

University of Athens

Responsible Party

Evangelos J. Giamarellos-Bourboulis, M.D.

Principal Investigators

Athanasios Skoutelis, MD

Evangelos J Giamarellos-Bourboulis, MD, PhD

George Chrysos, MD, PhD

Styliani Symbardi, MD, PhD

Zoi Alexiou, MD, PhD

Kostantinos Syrigos, MD, PhD

George Daikos, MD, PhD

Panagiotis Gargalianos, MD, PhD

Malvina Lada, MD, PhD

Charalambos Gogos, MD, PhD

Ilias Athanasiadis, MD, PhD

Symeon Metallidis, MD, PhD

Locations

5th Department of Internal Medicine, Evangelismos Athens General Hospital

1st Department of Internal Medicine, "G.Gennimatas" General hospital

1st Department of Internal Medicine, Laikon General Hospital

3rd Department of Internal Medicine, Sotiria General Hospital

4th Department of Internal Medicine, ATTIKON University Hospital

2nd Department of Internal Medicine, Sismanogleion General Hospital

1st Department of Internal Medicine, Thriassio General Hospital

2nd Department of Internal Medicine, Thriasio General Hospital

2nd Department of Oncology, Mitera Hospital

Department of Internal Medicine, Patras University Hospital

Infections Unit Tzaneion General Hospital

1st Department of Internal Medicine, AHEPA University Hospital

Countries

References

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.

Other Identifiers

CL01