Table 3.
Microbiological Cure by Presence of Clinical Symptoms and Human Immunodeficiency Virus or Bacterial Vaginosis Status at Baselinea (Modified Intention-to-Treat Population)
| Status at Baseline | Secnidazole 2 g (n = 64) | Placebo (n = 67) | |||
|---|---|---|---|---|---|
| Symptoms Present | Symptoms Absent | Symptoms Present | Symptoms Absent | P Valueb | |
| Microbiological curec, % (no./No.) | 92.9 (52/56) | 87.5 (7/8)d | 0 (0/55)d | 8.3 (1/12) | <.001 |
| 95% CI | 82.7–98.0 | 47.4–99.7 | .0–6.5 | .2–38.5 | <.001 |
| Microbiological curec, HIV, % (no./No.) | 100 (4/4) | … | 0 (0/4) | … | NC |
| Microbiological curec, BV, % (no./No.) | 95.2 (20/21) | … | … | 0 (0/17)d | <.001 |
| 95% CI | 76.2–99.9 | … | … | .0–19.5 | |
Abbreviations: BV, bacterial vaginosis; CI, confidence interval; HIV, human immunodeficiency virus; NC, not calculated.
aPost hoc analysis.
bP value vs placebo from a Cochran-Mantel-Haenszel test adjusted for clinical symptoms (present/absent) of trichomoniasis at baseline.
cInPouch Trichomonas vaginalis test negative.
dPatients with no test results were assumed to be positive (numbers imputed: secnidazole [symptoms absent] = 1; placebo [symptoms present] = 3; placebo [symptoms absent] = 1).