Table 2

 Summary of clinical response rates for the per protocol population (n = 564) and supporting intent to treat analyses at test of cure (days 5–24 post-therapy) and at follow up (days 28–42 post-therapy) (for calculation of 95% CI, missing information and “indeterminate” cases were treated as non-successes)

Clinical responseIntent to treat (n = 741)Per protocol (n = 564)
Moxifloxacin (n = 378)Ofloxacin plus metronidazole (n = 363)Moxifloxacin (n = 275)Ofloxacin plus metronidazole (n = 289)
*Reasons for indeterminate/missing given in figure 1 (on STI website (www.stijournal.com/supplemental).
†Only clinical failures were carried forward from TOC, improvements were re-assessed by the investigator at the follow up visit.
Test of cure (TOC)
    Clinical resolution286 (75.7%)300 (82.6%)248 (90.2%)262 (90.7%)
    Clinical failure or <70% improvement46 (12.2%)41 (11.3%)27 (9.8%)27 (9.3%)
    Indeterminate/missing*46 (12.2%)22 (6.1%)00
    Treatment difference (95% CI)
    Indeterminates/missing considered non-successes−6.9% (−12.3% to −0.9%)−0.5% (−5.7% to 4.0%)
    Indeterminates/missing excluded−1.8% (−6.9% to 3.2%)
Follow up
    Continued resolution284 (75.1%)294 (81.0%)236 (85.8%)254 (87.9%)
    Clinical relapse12 (3.2%)15 (4.1%)10 (3.6%)11 (3.8%)
    Failures carried forward from TOC†36 (9.5%)22 (6.1%)22 (8.0%)16 (5.5%)
    Indeterminate/missing*46 (12.2%)32 (8.8%)7 (2.5%)8 (2.8%)
    Treatment difference (95% CI)
    Indeterminates/missing considered non-successes−5.9% (−11.5% to 0.3%)−2.1% (−8.0% to 3.1%)
    Indeterminates/missing excluded−3.3% (−8.3% to 1.8%)−2.3 (−7.8% to 2.6%)