Table 2.
Summary of Primary and Secondary (MBI-CLABSI, SBSI, SPBC, Any positive blood culture) Outcomes
| Events in Control Clinics | Events in Intervention Clinics | Crude Control IR per 1000 at-risk days (95%CI) | Crude Intervention IR per 1000 at-risk days (95%CI) | Crude IRR (95% CI) | p-value | Adjusted IRRa (95% CI) | p-value | |
|---|---|---|---|---|---|---|---|---|
| ITT Analyses | ||||||||
| CLABSI, as assigned (primary outcome) | 123 | 109 | 1.38 (1.08 to 1.77) | 1.23 (0.94 to 1.60) | 0.86b (0.63 to 1.18) | 0.35 | 0.83 (0.63 to 1.11) | 0.22 |
| MBI-CLABSI, as assigned | 16 | 10 | 0.18 (0.08 to 0.40) | 0.11 (0.05 to 0.24) | 0.58c (0.22 to 1.54) | 0.27 | 0.54 (0.17 to 1.75) | 0.30 |
| Secondary BSI, as assigned | 11 | 0 | 0.12 (0.06 to 0.26) | 0 | 0 | - | - | - |
| Single positive blood culture, as assigned | 36 | 51 | 0.40 (0.23 to 0.70) | 0.57 (0.35 to 0.95) | 1.37b,c (0.77 to 2.42) | 0.28 | 1.38c (0.76 to 2.48) | 0.29 |
| Any positive blood culture, as assigned (includes CLABSI, MBI-CLABSI, SBSI, SPBC) | 186 | 170 | 2.09 (1.67 to 2.62) | 1.91 (1.43 to 2.56) | 0.85b (0.62 to 1.17) | 0.31 | 0.81 (0.61 to 1.07) | 0.14 |
| Per Protocol Analysis | ||||||||
| CLABSI, as assigned | 113 | 84 | 1.27 (0.95 to 1.69) | 0.95 (0.72 to 1.25) | 0.73b (0.49 to 1.07) | 0.11 | 0.71 (0.48 to 1.04) | 0.08 |
| MBI-CLABSI, as assigned | 14 | 8 | 0.16 (0.06 to 0.39) | 0.09 (0.04 to 0.20) | 0.52 (0.19 to 1.46) | 0.21 | 0.48 (0.15 to 1.60) | 0.23 |
| Secondary BSI, as assigned | 11 | 0 | 0.12 (0.06 to 0.26) | 0 | 0 | - | - | - |
| Single positive blood culture, as assigned | 29 | 42 | 0.33 (0.19 to 0.57) | 0.47 (0.28 to 0.80) | 1.39b,c (0.76 to 2.57) | 0.29 | 1.35 (0.73 to 2.49) | 0.34 |
| Any positive blood culture, as assigned (includes CLABSI, MBI-CLABSI, SBSI, SPBC) | 167 | 134 | 1.88 (1.47 to 2.39) | 1.51 (1.14 to 2.00) | 0.75b (0.53 to 1.06) | 0.100 | 0.72 (0.52 to 0.99) | 0.045 |
CLABSI - central line-associated bloodstream infection; MBI-CLABSI – mucosal barrier injury central line-associated bloodstream infection; SBSI – secondary bloodstream infection; SPBC - single positive blood culture; IR – Incidence rate; IRR – Incidence rate ratio
Primary outcome highlighted in yellow
a
adjusted for the year-specific total number of HCT patients and the use of chlorhexidine impregnated disc
b
no statistically significant interaction between intervention and period
c
the planned model did not converge, a generalized linear model with unit-correlated robust variance was used instead