Table 2.
Study Population and Statistics | Cervical/Urethral | Rectal | Pharyngeal | All Anatomic Sites |
---|---|---|---|---|
Intent-to-treata | ||||
Number of infections with microbiological cure, n | 38 | 81 | 35 | 154 |
Number of infections, n | 39 | 89 | 40 | 168 |
Microbiological cure, % | 97.4 | 91 | 87.5 | 91.7 |
95% CI, % | 90.4–100.0 | 85.0–100.0 | 77.0–100.0 | 87.6–100.0 |
Microbiological intent-to-treatb | ||||
Number of infections with microbiological cure, n | 33 | 74 | 14 | 121 |
Number of infections, n | 34 | 79 | 16 | 129 |
Microbiological cure, % | 97.1 | 93.7 | 87.5 | 93.8 |
95% CI, % | 89.1–100.0 | 88.0–100.0 | 69.5–100.0 | 89.6–100.0 |
Per-protocolc | ||||
Number of infections with microbiological cure, n | 30 | 73 | 14 | 117 |
Number of infections, n | 30 | 73 | 14 | 117 |
Microbiological cure, % | 100 | 100 | 100 | 100 |
95% CI, % | 90.5–100.0 | 96.0–100.0 | 80.7–100.0 | 97.5–100.0 |
Abbreviation: CI, confidence interval.
aThe intent-to-treat population included all infections in subjects enrolled who had a culture-positive N. gonorrhoeae infection at enrollment regardless of repeat gyrA serine 91 N. gonorrhoeae result at enrollment.
bThe microbiological intent-to-treat population for the specified anatomic site included only those with a wild-type gyrA serine 91 N. gonorrhoeae culture-positive result at enrollment.
cThe per-protocol population for the specified anatomic site included those in the microbiological intent-to-treat population with a follow-up culture result collected within the protocol-specified follow-up visit window (ie, 5–10 days after enrollment) and who did not receive any contraindicated medication or systemic antibiotic prior to the follow-up visit.