Table 2. Microbiologic Effect at Day 28.
This table summarizes analysis of primary endpoint, i.e. proportion of participants in the ITT-E population with a MRSA-negative culture at Day 28, adjusted for interim review. Also summarized is the proportion of MRSA-negative cultures at Day 28 among participants with a MRSA-positive culture at screening. For participants that have both an OP and expectorated sputum sample available at a given visit, a positive respiratory culture result is based on MRSA being present in either the OP or expectorated sputum sample; a negative result is based on MRSA being absent from both the OP and expectorated sputum samples.
| Treatment (N=24) | Observational Control (N=21) | Difference (95% CI) | p-value | |
|---|---|---|---|---|
| Screening | ||||
| Number screened | 24 | 21 | ||
| MRSA Positive at screen, n (%) | 14 (58%) | 17 (81%) | -23% (-45%, 4%)[1] | 0.12[2] |
|
| ||||
| Day 28 | ||||
| Number completed | 22 | 19 | ||
| MRSA Negative at Day 28, n (%) | 18 (82%) | 5 (26%) | 52% (23%, 80%)[3] | <0.001 [3] |
|
| ||||
| Change from Screening to Day 28 | ||||
| Number Cultures MRSA Positive at Screening [4] | 12 | 15 | ||
| Changed to MRSA Negative from Screening to Day 28, n (%) [5] | 8 (67%) | 2 (13%) | 49% (22%, 71%)[3] | <0.001 [3] |
95% confidence interval calculated using the Newcombe -Wilson method without continuity correction.
The p-value is obtained from the Fisher's exact test.
Adjusted for the interim reviews.
Number of participants with both a MRSA positive respiratory culture result available at Screening, and a non-missing MRSA culture result at Day 28.
Percent value is based on the number of participants with a MRSA positive respiratory culture result available at Screening.