Table. 2—

Evaluability for clinical and microbiological efficacy in the intent-to-treat population#

Uncomplicated groupComplicated group
Levo.Azithro.Levo.Amox./clav.
Subjects n192202187182
Total evaluable for clinical efficacy143 (74.5)151 (74.8)120 (64.2)126 (69.2)
Reasons for nonevaluability
 Unconfirmed clinical diagnosis6 (3.1)6 (3.0)27 (14.4)19 (10.4)
 Lost to follow-up2 (1.0)7 (3.5)4 (2.1)5 (2.7)
 Deviated from protocol dosing regimen3 (1.6)3 (1.5)11 (5.9)8 (4.4)
 Inappropriate post-therapy evaluation date12 (6.3)9 (4.5)13 (7.0)8 (4.4)
 Effective concomitant therapy1 (0.5)0 (0.0)1 (0.5)0 (0.0)
 Other protocol violation1 (0.5)1 (0.5)1 (0.5)8 (4.4)
 Site disqualified24 (12.5)25 (12.4)10 (5.3)8 (4.4)
Total evaluable for microbiological efficacy80 (41.7)87 (43.1)86 (46.0)89 (48.9)
Reasons for nonevaluability
 Unconfirmed clinical diagnosis6 (3.1)6 (3.0)27 (14.4)19 (10.4)
 Infection not bacteriologically proven73 (38.0)74 (36.6)44 (23.5)46 (25.3)
 Lost to follow-up0 (0.0)3 (1.5)3 (1.6)3 (1.6)
 Deviated from protocol dosing regimen1 (0.5)1 (0.5)7 (3.7)6 (3.3)
 Inappropriate bacteriological culture6 (3.1)5 (2.5)8 (4.3)5 (2.7)
 Effective concomitant therapy1 (0.5)0 (0.0)1 (0.5)0 (0.0)
 Other protocol violation1 (0.5)1 (0.5)1 (0.5)6 (3.3)
 Site disqualified24 (12.5)25 (12.4)10 (5.3)8 (4.4)
  • Data are presented as n (%). Levo.: levofloxacin; azithro.: azithromycin; amox.: amoxicillin; clav.: clavulanate. #: patients were counted only once; : one clinical site enrolled 67 subjects; after an audit of this site and review of the data collected, there were outstanding questions about the site's determination of disease severity and clinical assessment of the subjects; the subjects enrolled at this site were disqualified from the clinical, microbiological and pharmacoeconomic populations, but remained in the safety populations; the disqualification of these subjects occurred during the course of the study and before closure of the database and subsequent unblinding of the treatment of the subjects.