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

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Antibiotic-associated diarrhea (AAD) is the most common gastrointestinal complication of antibiotic use, with potentially serious clinical impact. The aim of this study is to assess the efficacy and safety of Saccharomyces boulardii in the prevention of AAD in adult patients with lower respiratory tract infection (LRTI) treated in a hospital.

A multicenter, randomized, parallel-group, double-blind, placebo-controlled study is conducted whereby adults who are hospitalized due to LRTI and treated with intravenous antibiotics and randomized to capsules containing S. boulardii or indistinguishable placebo. The outcome measures were: relevant clinical features, gastrointestinal symptoms, and adverse events.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Centre of Serbia
• Collaborator: Institute for Pulmonary Diseases of Vojvodina

Criteria

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 inflammatory bowel disease such as Crohn's Disease or ulcerative colitis; evidence of other GI infections ie parasitic infection, Salmonella, Shigella, history of colon carcinoma, irritable bowel syndrome (IBS)

• Subjects with aspiration pneumonia

• Subjects with chronic alcoholism

• Subjects with confirmed influenza

• Neutrophil count <500 cells/mm3

• Patients with subclavian central line

• AST, ALT > 3x upper limit normal (ULN)

• Active chemotherapy, receipt of organ transplant

• Participation on another clinical study within the last 30 days

• Insufficient ability or willingness to co-operate

• In the judgment of the investigator any factors (e.g. other treatment) that could invalidate the treatment result