Table 6.
Reasons for Treatment Failure
| Reason for Overall Nonresponse at Test of Cure | mMITT-R | mMITT-S | mMITT | |||
|---|---|---|---|---|---|---|
| Sulopenem (N = 147) n (%) |
Ciprofloxacin (N = 139) n (%) |
Sulopenem (N = 370) n (%) |
Ciprofloxacin (N = 415) n (%) |
Sulopenem (N= 517) n (%) |
Ciprofloxacin (N= 554) n (%) |
|
| Total number of nonresponders | 49 (33.3) | 84 (60.4) | 105 (28.4) | 65 (15.7) | 154 (29.8) | 149 (26.9) |
| ȃMicrobiologic failure only | 27 (18.4) | 38 (27.3) | 47 (12.7) | 16 (3.9) | 74 (14.3) | 54 (9.7) |
| ȃClinical failure only | 17 (11.6) | 13 (9.4) | 38 (10.3) | 42 (10.1) | 55 (10.6) | 55 (9.9) |
| ȃBoth clinical and microbiologic failure | 5 (3.4) | 25 (18.0) | 18 (4.9) | 4 (1.0) | 23 (4.4) | 29 (5.2) |
| ȃReceipt of nonstudy antibacterial therapy for uUTI | 0 (0.0) | 11 (7.9) | 4 (1.1) | 5 (1.2) | 4 (0.8) | 16 (2.9) |
| ȃDeath due to uUTI | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| ȃIndeterminate outcome | 6 (4.1) | 5 (3.6) | 18 (4.9) | 24 (5.8) | 24 (4.6) | 29 (5.2) |
Microbiologic failure is defined as test-of-cure visit urine culture with ≥103 CFU/mL of the baseline uropathogen; clinical failure is defined as no resolution or worsening of uUTI symptoms present at trial entry and/or new uUTI symptoms. Patients who received nonstudy antibacterial therapy may have another reason for failure.
Abbreviations: mMITT, microbiologic modified intent-to-treat with a qualifying baseline urine isolate; mMITT-R, microbiologic modified intent-to-treat with a qualifying baseline urine isolate nonsusceptible to ciprofloxacin; mMITT-S, microbiologic modified intent-to-treat with a qualifying baseline urine isolate susceptible to ciprofloxacin; uUTI, uncomplicated urinary tract infection.