Last updated: 03/05/2019 07:20:17

Evaluation of the immune response to Clostridium difficile in adults with Clostridium difficile infection (CDI)

GSK study ID
116509
See study documents
Clinicaltrials.gov ID
NCT01716533
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A serological study in adult subjects with Clostridium difficile infection
Trial description: This study aims to 1) evaluate the C. difficile-specific immune response in CDI patients and 2) explore the difference in immune response between the patients with CDI recurrence and those with a sustained clinical response.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Serum anti-toxin A and anti-toxin B antibody concentrations at Day 14

Timeframe: At Day 14

Serum F2 C-terminal anti-toxin B antibody concentrations

Timeframe: At Day 14

Secondary outcomes:

Serum anti-toxin A and anti-toxin B antibody concentrations at Day 0 and Day 72

Timeframe: At Day 0 and at Day 72

Serum neutralizing anti-toxin A and anti-toxin B antibody titers at Day 14

Timeframe: At Day 14

Serum neutralizing anti-toxin A and anti-toxin B antibody titers at Day 0, within 10 days after recurrence and at Day 72

Timeframe: At Day 0, within 10 days after start of recurrent episode if any, and at end of follow-up (Day 72)

Number of subjects with Clostridium difficile infection (CDI) recurrence

Timeframe: From Day 0 to Day 72

CDI initial episodes severity characteristics, in all subjects

Timeframe: At Day 0

Number of subjects with initial CDI episode by severity, in all subjects

Timeframe: At Day 0

Number of subjects with CDI recurrence by severity, in those subjects who recur

Timeframe: At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant

Number of subjects with failure of antibiotic treatment

Timeframe: Within 3 months before the initial CDI episodes

Number of subjects with risk factors associated with the initial CDI episode

Timeframe: At Day 0

Number of subjects with risk factors associated with the CDI recurrence

Timeframe: At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant

Interventions:
  • Procedure/surgery: Blood sampling
  • Other: Stool sample collection
    • Enrollment:
    57
    Primary completion date:
    2015-01-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Clostridium difficile
    Product
    GSK2904545A
    Collaborators
    Not applicable
    Study date(s)
    February 2013 to June 2015
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol or/ and subjects who can receive assistance from his/ her legally acceptable representative (LAR) or a designate who can and will comply with the requirements of the protocol.
    • A male or female aged 18 years or older at the time of enrolment.
    • Concurrently participating or planning to participate in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
    • Previous CDI episode within the previous 6 months before study enrolment (except for up to ~25% of the subjects).
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes that they can and will comply with the requirements of the protocol or/ and subjects who can receive assistance from his/ her legally acceptable representative (LAR) or a designate who can and will comply with the requirements of the protocol.

      • A male or female aged 18 years or older at the time of enrolment.
      • Written informed consent obtained from the subject/ LAR of the subject.
      • A reasonable prognosis of survival during the study period as judged by the investigator.
      • Outpatients, emergency room and/ or hospitalized subjects diagnosed with CDI for which the symptoms started maximum 14 days prior to study enrolment.
      • Subjects who receive or plan to receive antibiotic treatment to treat the CDI episode.
    Exclusion criteria:

      Concurrently participating or planning to participate in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

      • Previous CDI episode within the previous 6 months before study enrolment (except for up to ~25% of the subjects).
      • Chronic diarrheal illness such as, but not limited to, ulcerative colitis or Crohn's disease.
      • Planned surgery for CDI within 24 hours after study entry.
      • Previous vaccination against Clostridium difficile.
      • Having received a Clostridium difficile monoclonal antibody product(s) within the previous 3 months or planned administration during the study period.
      • Administration of immunoglobulins within the previous 3 months or planned administration during the study period.
      • Subject having any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject participating in the study, would make it unlikely for the subject to complete the study, or would confound the results of the study.
      • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within the previous 6 months.
      • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
      • Family history of congenital or hereditary immunodeficiency.
      • Major congenital defects.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02215
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Halifax, Nova Scotia, Canada, B3K 6R8
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Hamilton, Ontario, Canada, L8N 4A6
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M5G 1X5
    Status
    Study Complete
    Contact us

    Study documents

    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2015-01-06
    Actual study completion date
    2015-01-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website