Evaluation of the Immune Response to Clostridium Difficile in Adults With Clostridium Difficile Infection (CDI) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Bacterial Vaccines	Procedure: Blood sampling Other: Stool sample collection	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	A Serological Study in Adult Subjects With Clostridium Difficile Infection

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Immune response to C. difficile as measured in blood samples in all subjects [ Time Frame: At Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immune response to C. difficile as measured in blood samples in all subjects [ Time Frame: At Day 0, at recurrence (within 5 days of start diarrhea) and at end of follow-up (Day 72) ] [ Designated as safety issue: No ]
Functional immune response to C. difficile as measured in blood samples in all subjects [ Time Frame: At Day 0, at Day 14, at recurrence (within 5 days of start diarrhea) and at end of follow-up (Day 72) ] [ Designated as safety issue: No ]
Occurrence of CDI recurrence [ Time Frame: During a minimum 30-day follow-up period after clinical response to the antibiotic treatment to treat the initial CDI episode ] [ Designated as safety issue: No ]
Occurrence of the initial CDI episode by severity, in all subjects [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
Occurrence of the CDI recurrence by severity, in those subjects who recur [ Time Frame: At recurrence (within 5 days of start diarrhea) ] [ Designated as safety issue: No ]
Occurrence of failure of antibiotic treatment [ Time Frame: At the end of the antibiotic treatment (minimum 7 days) ] [ Designated as safety issue: No ]
Presence of risk factors associated with the initial CDI episode, in all subjects [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
Presence of risk factors associated with the CDI recurrence [ Time Frame: At recurrence (within 5 days of start diarrhea) ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	February 2013
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Recurrence group Subjects who experience recurrence of CDI after clinical response to antibiotic treatment to treat the initial CDI episode.	Procedure: Blood sampling Blood sampling will be done at Day 0, at Day 14, at recurrence (if applicable) and at end of follow-up. Other: Stool sample collection Stool samples will be collected around Day 0, around Day 14 and at recurrence (if applicable).
Sustained response group Subjects who do not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.	Procedure: Blood sampling Blood sampling will be done at Day 0, at Day 14, at recurrence (if applicable) and at end of follow-up. Other: Stool sample collection Stool samples will be collected around Day 0, around Day 14 and at recurrence (if applicable).

Detailed Description:

Patients with an initial episode of CDI will be followed up for CDI recurrence or sustained clinical response. The subjects will be allocated into 2 groups at the study end:

Recurrence Group: Subjects who experience recurrence of CDI after clinical response to antibiotic treatment to treat the initial CDI episode.
Sustained response Group: Subjects who do not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.
Emergency room and/ or hospitalized subjects diagnosed with CDI for which the symptoms started maximum 5 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 and/or any blood products 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716533

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Locations

United States, Texas
GSK Investigational Site	Recruiting
Houston, Texas, United States, 77030
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com
Canada, Nova Scotia
GSK Investigational Site	Not yet recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com
Canada, Ontario
GSK Investigational Site	Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01716533 History of Changes
Other Study ID Numbers:	116509
Study First Received:	October 18, 2012
Last Updated:	March 21, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Serological
Immune response
Adults
Clostridium difficile

Additional relevant MeSH terms:

Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013