S. Boulardii in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adults With Respiratory Tract Infections

Inclusion Criteria: * Male or female subjects age ≥65 years. * Informed consent (IC) obtained and signed prior to study participation * For female subjects: proof of being at least 1 year post-menopausal * Expected minimum hospital stay of 5 days * Requiring ≥5 day course of intravenous (IV) antibiotic * Diagnosis of lower respiratory tract infection (LRTI) * The subject is willing and able to comply with all testing and study requirements as defined in the protocol. Exclusion Criteria: * Active diarrhea (where diarrhea is defined as 3 or more unformed/liquid stools on day prior to randomization) * Subjects with diarrhea in past 2 weeks * Current treatment for CDAD or ongoing active CDAD infection, as evidenced by clinical signs of diarrhea along with the presence of toxin A and/or B (or their respective genes) of C. difficile in the stool * Number of previous CDAD episodes \>1 * Any previously documented CDI within 8 weeks prior to randomization * Use of broad spectrum antibiotics within 2 months of start of study drug. Antibiotics including those not specified in this protocol for the treatment of the current CAP episode are allowed within 24 h of start of study drug and the protocol-defined treatment for CAP. * Current treatment with non-beta lactam antibiotics other than macrolides * Risk of death within 90 days of study entry according to the clinical judgment of the investigator * Known intolerance of study drug/ingredients * History of or active, non-controlled infl…