Clinical trial NCT01716533: Evaluation of the Immune Response to Clostridium Difficile in Adults With Clostridium Difficile Infection (CDI)
Official title: A Serological Study in Adult Subjects With Clostridium Difficile Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections, Clostridium Difficile
Keywords: Serological
Adults
Clostridium difficile
Adult CDI patients
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-10-30
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

This protocol has been amended twice to improve recruitment of subjects in the study.

Eligibility 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.

Primary outcomes:
measure: Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 14
timeFrame: At Day 14
measure: Serum F2 C-terminal Anti-toxin B Antibody Concentrations
timeFrame: At Day 14
Secondary outcomes:
measure: Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 0 and Day 72
timeFrame: At Day 0 and at Day 72
measure: Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 14
timeFrame: At Day 14
measure: 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)
measure: Number of Subjects With Clostridium Difficile Infection (CDI) Recurrence
timeFrame: From Day 0 to Day 72
measure: CDI Initial Episodes Severity Characteristics, in All Subjects
timeFrame: At Day 0
measure: Number of Subjects With Initial CDI Episode by Severity, in All Subjects
timeFrame: At Day 0
measure: 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
measure: Number of Subjects With Failure of Antibiotic Treatment
timeFrame: Within 3 months before the initial CDI episodes
measure: Number of Subjects With Risk Factors Associated With the Initial CDI Episode
timeFrame: At Day 0
measure: 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
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: