Please note: This trial has finished recruiting and is not accepting new participants.

Research Center (North & Northwest Houston Area): DM Clinical Research
Location: 710 Lawrence Street, Tomball, TX 77375
Lead Doctor: Dr. Earl F Martin

Research Center (Central & Southwest Houston Area): Texas Center for Drug Development, Inc.
Location: 6550 Mapleridge St. Suite 201. Houston, TX 77081
Lead Doctor: Dr Teresa Becker

Ethics Committee: This study has been reviewed by the Copernicus Group Independent Review Board

Background

Clostridium difficile caused almost half a million infections among patients in the United States in a single year, according to a study by the Centers for Disease Control and Prevention (CDC). Older Americans are especially vulnerable to this potentially deadly diarrheal infection. (1)

This research study aims to assess whether a new investigational vaccine can prevent severe diarrhea caused by C. diff.

Men and women aged 50 years or older are invited to participate. Participants are required to attend 5 study visits over approximately 7 months as well as follow up phone visits and possibly unscheduled visits over approximately 2.5 years.

• You will be reimbursed for travel and related expenses up to $75.00 per site visit. Travel reimbursement may also be available for a caregiver to travel with you for a visit related to a bacterial infection causing severe diarrhea.
• You will be helping to advance medical research.

Your Rights

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.
• Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

• Men and women aged 50 or older
• Have not had a prior episode of C.Diff
• Who have received antibiotics in the past 3 months or have had frequent doctor visits over the past year
• Able to attend 5 study visits at the research site over approximately 7 months as well as follow up phone visits and possibly unscheduled visits appointments for an additional 2.5 years

(1) CDC Newsroom. https://www.cdc.gov/media/releases/2015/p0225-clostridium-difficile.html