MedPath

Assessment of a Novel Method to Prevent MRSA Recurrence

Phase 1
Completed
Registration Number
CTRI/2018/05/013981
Lead Sponsor
BioPlx Microbiomics Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
765
Inclusion Criteria

Microbiological test results showing MRSA colonization, such as positive CHROMagar• MRSA plate reading

Exclusion Criteria

1. cancer

2. autoimmune disease

3. congenital immunodeficiencies

4. uncontrolled diabetes mellitus

5. breast-feeding women or women who were or might become pregnant during the study period

6. known history of HIV infection

7. concurrent and chronic therapy with immunosuppressive drugs

8. receipt of a live-virus vaccine during the last 2 months

9. recent use of corticosteroids or other immunosuppressive medications

10. eczema

11. psoriasis

12. atopic dermatitis

13. seborrheic dermatitis

14. drug eruptions

15. rosacea, hives (urticaria) > dry skin (xerosis)

16. administration/consumption of topical or systemic antibiotics in the last 14 days

17. active psychiatric disease

18. history of major depression, psychosis, or in-patient hospitalization for psychiatric management.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
MRSA colonization recurrence rate. After participants have been confirmed as MRSA negative on Day 1, recurrence is defined as the presence of greater than 24 CFUs in a selective growth media MRSA test (such as CHROMagarâ?¢ MRSA) and in any one of the four sites sampled at each time point (hand, throat, axilla, and nares).Timepoint: Day 0, Day 1, week 4, and week 8
Secondary Outcome Measures
NameTimeMethod
MRSA colonization recurrence rate. After participants have been confirmed as MRSA negative on Day 1, recurrence is defined as the presence of greater than 24 CFUs in a selective growth media MRSA test (such as CHROMagarâ?¢ MRSA) and in any one of the four sites sampled at each time point (hand, throat, axilla, and nares).Timepoint: Day 0, Day 1, and weekly thereafter through week 26
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