Table 4.

Agreement between investigator-assessed clinical outcome and structured patient interview-assessed clinical outcome at each time point in the microbiological intention-to-treat population.

Time point–investigator assessment, N = 371	Clinical outcome by SPI, a N = 371				Kappa coefficient (κ)
	Clinical cure, n (%)	Clinical failure, n (%)	Relapse, n (%)	Indeterminate b n (%)
Early assessment
• Clinical cure	284 (76.5)	52 (14.0)		0	0.267
• Clinical failure	15 (4.0)	16 (4.3)		2 (0.5)
• Indeterminate c	0	0		2 (0.5)
End of treatment
• Clinical cure	354 (95.4)	11 (3.0)		0	0.287
• Clinical failure	3 (0.8)	1 (0.3)		0
• Indeterminate c	0	0		2 (0.5)
Test of cure
• Clinical cure	322 (86.8)	8 (2.2)		0	0.820
• Clinical failure	5 (1.3)	17 (4.6)		0
• Indeterminate c	0	1 (0.3)		18 (4.9)
Follow-up
• Clinical cure	279 (75.2)	8 (2.2)	4 (1.1)	0	0.766
• Clinical failure	2 (0.5)	29 (7.8)	1 (0.3)	0
• Relapse	14 (3.8)	0	10 (2.7)	0
• Indeterminate c	2 (0.5)	0	0	22 (5.9)

cUTI, complicated urinary tract infection; FUP, follow-up; SPI, structured patient interview; TOC, test-of-cure.

^aClinical outcome based on patient-reported symptoms was assessed by symptom resolution that included core symptoms of cUTI (dysuria, urinary frequency, urinary urgency, suprapubic pain, and flank pain).

Clinical cure: resolution or improvement of all the core baseline symptoms at TOC.

Clinical failure: no resolution or improvement of some core baseline symptoms at TOC.

^bIndeterminate: any core symptoms missing at either baseline or TOC.

^cIndeterminate: lost to follow-up such that a determination of clinical response (success or failure) cannot be made.

Relapse: signs and/or symptoms of cUTI that were absent at TOC reappear at FUP.