Evaluation of the Immune Response to Clostridium Difficile in Adults With Clostridium Difficile Infection (CDI)

NCT01716533 | Completed Results

• 1 other identifier: 116509
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 5

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.

Conditions

Infections, Clostridium Difficile

Keywords

Serological; Adults; Clostridium difficile; Adult CDI patients

Outcome Measures

Primary Outcomes (2)

• Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 14

  Serum anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by the Enzyme Linked Immunosorbent Assay (ELISA) for the cut-off of equal to or above (≥) 100 EU/mL.

  At Day 14

• Serum F2 C-terminal Anti-toxin B Antibody Concentrations

  Serum F2 C-terminal anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by ELISA for the cut-off of 13.16 EU/mL.

  At Day 14

Secondary Outcomes (10)

• Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 0 and Day 72

  At Day 0 and at Day 72

• Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 14

  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

  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

  From Day 0 to Day 72

• CDI Initial Episodes Severity Characteristics, in All Subjects

  At Day 0

Study Arms (4)

Recurrence group

OTHER

Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode.

Procedure: Blood sampling; Other: Stool sample collection

Sustained response group

OTHER

Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.

Procedure: Blood sampling; Other: Stool sample collection

Failure to antibiotic Group

OTHER

Male or female subjects aged 18 years or older at the time of enrollment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode.

Procedure: Blood sampling; Other: Stool sample collection

Unclassified Group

OTHER

Male or female subjects aged 18 years or older at the time of enrollment, who couldn't be classified as sustained response, recurrence, or failure to antibiotic due to missing data.

Procedure: Blood sampling; Other: Stool sample collection

Interventions

Blood sampling PROCEDURE

Blood sampling will be done at Day 0, at Day 14, at recurrence (if applicable) and at end of follow-up.

Failure to antibiotic Group; Recurrence group; Sustained response group; Unclassified Group

Stool sample collection OTHER

Stool samples will be collected around Day 0, around Day 14 and at recurrence (if applicable).

Failure to antibiotic Group; Recurrence group; Sustained response group; Unclassified Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Hamilton, Ontario, L8N 4A6, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 30, 2012
• Study Start: February 2, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 7, 2019
• Results First Posted: June 7, 2019

Record last verified: 2019-02

Locations

US (3); CA (2)