Clinical Trial 39901

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Riverdale, GA 30274


Study Summary:

A Phase 3 Placebo Controlled, Study to Evaluate the Safety, Tolerability, and Efficacy of SER-109 vs. Placebo to Reduce Recurrence of Clostridium Difficile Infection (CDI) in Adults Who Have Received Antibacterial Drug Treatment for Recurrent CDI


Recurrent Clostridium Difficile

Men and women at least 18 years of age, with a qualifying episode of CDI as defined by:

 

 ≥ 3 unformed stools per day for 2 consecutive days

 A positive C. difficile stool toxin assay

 The requirement of CDI SOC antibiotic therapy (defined as 10 to 21 days of treatment with vancomycin [125 mg QID] and/or fidaxomicin [200 mg BID]

 ≥ 3 episodes of CDI within the previous 12 months, inclusive of the current episode, with documented history of ≥ 2 episodes, inclusive of the current (qualifying) episode

 The requirement that the subject can be dosed with study drug within 4 days of SOC antibiotic completion


Qualified Participants May Receive:

COMPENSATION FOR TIME

COMPENSATION FOR TRAVEL

FREE MEDICATION 

MEDICAL CARE

INSURANCE NOT REQUIRED


Research Site Profile

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Study is Available At:

INFINITE CLINICAL TRIALS
113 UPPER RIVERDALE RD
Riverdale, GA 30274
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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.