Table 3. Clinical and Microbiologic Outcomes.
| Clinical and Bacteriologic Outcome | No./Total No. (%) | Difference, % (95% CI) | P Valuea | |
|---|---|---|---|---|
| Nitrofurantoin (n = 255) |
Fosfomycin (n = 258) |
|||
| Primary Outcome | ||||
| Clinical response at 28 db | ||||
| Clinical resolution | 171/244 (70) | 139/241 (58) | 12 (4-21) | .004 |
| Clinical failure | 66/244 (27) | 94/241 (39) | ||
| Indeterminate | 7/244 (3) | 8/241 (3) | ||
| Missingc | 11 (4) | 17 (7) | ||
| Secondary Outcomes | ||||
| Clinical response at 14 d | ||||
| Clinical resolution | 184/247 (75) | 162/247 (66) | 9 (1-17) | .03 |
| Clinical failure | 56/247 (23) | 75/247 (30) | ||
| Indeterminate | 7/247 (3) | 10/247 (4) | ||
| Missingc | 8 (3) | 11 (4) | ||
| Microbiologic response at 28 db | ||||
| Culture obtained/baseline culture positive | 175/194 (90) | 163/183 (89) | ||
| Bacteriologic success through 28 d | 129/175 (74) | 103/163 (63) | 11 (1-20) | .04 |
| Bacteriologic success failure by 28 d | 46/175 (26) | 60/163 (37) | ||
| Microbiologic response at 14 d | ||||
| Culture obtained/baseline culture positive | 177/194 (91) | 165/183 (90) | ||
| Bacteriologic success through 14 d | 146/177 (82) | 121/165 (73) | 9 (0.4-18) | .04 |
| Bacteriologic success failure by 14 d | 31/177 (18) | 44/165 (27) | ||
Calculated using χ21 test.
Clinical response was defined as clinical resolution (complete resolution of symptoms and signs of urinary tract infection without prior failure), failure (need for additional or change in, antibiotic treatment due to a urinary tract infection, or discontinuation due to lack of efficacy), or indeterminate (either persistence of symptoms without objective evidence of infection or any extenuating circumstances precluding a classification of clinical resolution/failure). Microbiologic response was defined as resolution (eradication of the infecting strain with no recurrence of bacteriuria [<103 colony-forming units/mL] during follow-up) or failure (bacteriuria ≥103 colony-forming units/mL with the infecting strain).
Number of patients with missing data on this outcome measure and thus not included in this analysis (see eTables 2 and 3 in Supplement 3 for multiple imputation and sensitivity analyses for missing data).