None listed
Conditions
Interventions
Intervention1: BioPlx01-WT and components of skin decolonization.: 1) BioPlx01-WT - passive low virulence S. aureus strain with history of use as a preventative colonizer in thousands of newborns.
2)
Sponsors
BioPlx Microbiomics Pvt Ltd
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) Positive Staphylococcus aureus CHROMagar plate from screening nasal swab. 4) Agreement to avoid antibiotic use unless instructed by a physician for the duration of this study. 5) Agreement to avoid antimicrobial soaps and antiseptic applications on the skin for the duration of this study.
Exclusion criteria
Exclusion criteria: 1) Current use of oral, intravenous or topical antibiotics. 2) History of autoimmune disease or 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 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 |
|---|---|
| Cumulative incidence of dermal or mucosal events at 7 days post-application.Timepoint: Cumulative incidence of dermal or mucosal events at 7 days post-application. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactLove Aggarwal
Dr. Pratap Medical Centre
Outcome results
None listed