None listed
Conditions
Interventions
Intervention1: BioPlx01-WT probiotic strain: Following the standard skin decolonization regimen described in the comparator group, BioPlx01-WT, a relative of 502A suspended in phosphate buffered salin
Sponsors
BioPlx Microbiomics Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1) Provision of signed and dated informed consent form. 2) Stated willingness to comply with all study procedures and availability for the duration of the study. 3) History of positive Staphylococcus aureus bacteremia as confirmed by treating physician. 4) Positive methicillin-resistant Staphylococcus aureus CHROMagar plate from screening nasal swab. 5) Agreement to adhere to the avoidance of antibiotic use unless instructed by a physician and the use of antimicrobial soaps and skin antiseptic applications throughout study duration.
Exclusion criteria
Exclusion criteria: 1) Current use of oral, intravenous, or topical antibiotics. 2) History of autoimmune disease, immunosuppressive conditions or therapy. 3) Active diagnosis of cancer. 4) Active diagnosis of infection. 5) History of diabetes mellitus with HgbA1C > 6.5. 6) Planned pregnancy during the study or current pregnancy. 7) Febrile illness within 1 week of enrollment. 8) Receipt of a live virus vaccine within the 2 months prior to enrollment. 9) Treatment with another investigational drug or other intervention within 3 months of enrollment. 10) Chronic skin conditions such as eczema.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence or absence of MSSA or MRSA from axillae, nasal, throat and umbilical culture at 4 weeks.Timepoint: Weekly from weeks 1-4 after intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Presence or absence of MSSA or MRSA from axilla, nasal, throat, and umbilical culture at 8 weeks.Timepoint: Weekly from weeks 5-8 after intervention. | — |
Countries
India
Contacts
Public ContactLove Aggarwal
Dr. Pratap Medical Centre
Outcome results
None listed