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. 2020 Aug 7;73(2):298–303. doi: 10.1093/cid/ciaa596

Table 2.

Microbiologic Cure by Anatomic Site and Study Population, Gyrase A Serine 91 Neisseria gonorrhoeae Ciprofloxacin Treatment Study

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.