Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
Hellenic Sepsis Study Group
Information provided by (Responsible Party):
Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens

Tracking Information
First Submitted Date October 8, 2015
First Posted Date October 12, 2015
Last Update Posted Date October 5, 2017
Actual Study Start Date October 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2015)
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
Original Primary Outcome Measures
 (submitted: October 9, 2015)
Definition of prognostic biomarker [ Time Frame: 12 months ]
To develop a score based on clinical data, laboratory data, genetic information and biomarkers than can predict from the first day of diagnosis of CDI with at least 80% positive predictive value the risk of unfavorable outcome. Unfavorable outcome is defined as any of the following: presentation or progression into severe CDI, relapse; and death
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Personalized Needs in Clostridium Difficile Infections
Official Title Scoring Personalized Needs in Clostridium Difficile Infections for Fidaxomixin Therapy
Brief 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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood for human DNA extraction and human stool for whole bacterial DNA extraction. Sampling is done on the first day and on disease recurrence
Sampling Method Probability Sample
Study Population Patients with Clostridium difficile-associated diarrhea
Condition
  • Biologic Markers
  • Clinical Markers
Intervention Other: Development of biomarkers
Blood sampling
Other Names:
  • Single nucleotide polymorphisms
  • Serum cytokines
Study Groups/Cohorts Clostridium difficile infection
Patients with Clostridium difficile-associated diarrhea for development of biomarkers
Intervention: Other: Development of biomarkers
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 9, 2015)
150
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Exclusion Criteria:

1. No exclusion criteria exist

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT02573571
Other Study ID Numbers CL01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens
Study Sponsor University of Athens
Collaborators Hellenic Sepsis Study Group
Investigators
Principal Investigator: Athanasios Skoutelis, MD Evangelismos Athens General Hospital
Study Chair: Evangelos J Giamarellos-Bourboulis, MD, PhD ATTIKON University 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
PRS Account University of Athens
Verification Date October 2017