Efficacy and safety of levornidazole disodium phosphate for the treatment of pelvic inflammatory disease: A multicenter, double-blind, randomized trial
Abstract
To compare the efficacy and safety of levornidazole and levornidazole disodium phosphate in women with pelvic inflammatory disease.
Women from 12 hospitals in China received a 14-day treatment course comprising 7 days of intravenous therapy followed by 7 days of oral sequential therapy: intravenous levornidazole 0.5 g twice daily (Group A,
n
=49), levornidazole disodium phosphate 1.0 g once daily (Group B,
n
=49), or levornidazole disodium phosphate 0.5 g twice daily (Group C,
n
=46), followed by oral levofloxacin plus ornidazole for 7 days.
Of the 144 patients in the full analysis set (FAS), 131 (91.00%) were included in the per-protocol set and 38 (29.00%) were microbiologically valid. In the FAS, clinical cure rates at day 14 were 77.55%, 83.67%, and 82.61% for Groups A, B, and C, respectively (
P
=0.745). Bacteriological clearance rates were 76.47%, 93.75%, and 100.00%, respectively (
P
=0.248). Drug-related adverse events occurred less frequently in Group B than in Group A (38.78%
vs
. 61.22%;
P
=0.025).
Daily administration of levornidazole disodium phosphate achieved clinical and bacteriological efficacy comparable to twice-daily levornidazole in women with pelvic inflammatory disease and was associated with significantly fewer drug-related adverse events.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 144 participants or records.
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