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

Completed · Not applicable

Conditions studied: Infections, Clostridium Difficile

In brief

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.

Key facts

Study ID

NCT01716533

Run by

GlaxoSmithKline

People needed

57

Starts

2013-02-02

Expected to finish

2015-06-01

Last updated by the study team

2019-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Hamilton, Ontario, Canada
• GSK Investigational Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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