Microbiological effect at day 28
| 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% to 4%)* | 0.12† |
| Day 28 | ||||
| Number completed | 22 | 19 | ||
| MRSA-negative at day 28, n (%) | 18 (82%) | 5 (26%) | 52% (23% to 80%)‡ | <0.001‡ |
| Change from screening to day 28 | ||||
| Number MRSA-positive cultures at screening§ | 12 | 15 | ||
| Changed to MRSA-negative from screening to day 28, n (%)¶ | 8 (67%) | 2 (13%) | 49% (22% to 71%)‡ | <0.001‡ |
This table summarises analysis of primary end point, that is, proportion of participants in the ITT-E population with an MRSA-negative culture at day 28, adjusted for interim review. Also summarised is the proportion of MRSA-negative cultures at day 28 among participants with an 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.
*95% CI calculated using the Newcombe-Wilson method without continuity correction.
†The p value is obtained from Fisher's exact test.
‡Adjusted for the interim reviews.
§Number of participants with both an MRSA-positive respiratory culture result available at screening, and a non-missing MRSA culture result at day 28.
¶Per cent value is based on the number of participants with an MRSA-positive respiratory culture result available at screening.
ITT-E, intent-to-treat-efficacy; MRSA, methicillin-resistant Staphylococcus aureus; OP, oropharyngeal.