Table 3.

Summary of analyses results: ClearGuard facilities versus Tego+Curos facilities, for primary analysis and exploratory sensitivity analyses

VariableClinical Study Results and Exploratory Analyses
Primary Analysis (All PBC)CRBSI AnalysisCLABSI AnalysisARBSI AnalysisARBSI Analysis, Gram-Positive OrganismsARBSI Analysis, Gram-Negative OrganismsDe Novo CVC AnalysisNo Initial 21-d Censoring Analysis (All PBC)IV Antibiotic Starts within 3 d of a PBC Analysis
Number of patients in analysis
 Combined167116711671167116711671123919021671
 ClearGuard826826826826826826624942826
 Tego+Curos845845845845845845615960845
Cumulative duration (CVC-days)
 Combined183,106178,296183,106183,106183,106183,106115,321216,379183,106
 ClearGuard83,06481,83483,06483,06483,06483,06455,50499,43383,064
 Tego+Curos100,04296,462100,042100,042100,042100,04259,817116,946100,042
Number of events
 Combined9842768757315811973
 ClearGuard23101718144122717
 Tego+Curos753259694327469256
Event rate (events per 1000 CVC-days)
 Combined0.540.240.420.480.310.170.500.550.40
 ClearGuard0.280.120.200.220.170.050.220.270.20
 Tego+Curos0.750.330.590.690.430.270.770.790.56
 IRR0.370.370.350.310.390.180.280.350.37
 95% LCI0.200.190.170.160.190.060.130.180.21
 95% UCI0.680.720.700.610.790.510.590.670.62
 P value0.0010.0030.003<0.001<0.010.001<0.0010.002<0.001
  • IRRs<1 favor ClearGuard. 95% LCI, lower 95% confidence interval; 95% UCI, upper 95% confidence interval.