Lefamulin for Mycoplasma genitalium treatment failure in Australia and the USA: a case series and pilot open-label parallel arm randomised trial
Abstract
Objectives Mycoplasma genitalium (MG) causes urethritis and is associated with cervicitis, pelvic inflammatory disease and preterm delivery. Antimicrobial resistance is widespread and cure rates are declining. Lefamulin, a novel pleuromutilin, may be effective in cases of treatment failure. Methods Under compassionate access in Australia and a pilot open-label parallel arm randomised clinical trial in the USA, patients with urogenital MG infection and microbiological treatment failure or contraindications to moxifloxacin were treated with lefamulin monotherapy (600 mg orally two times per for 7 days) or sequential doxycycline-lefamulin (doxycycline 100 mg orally two times per day for 7 days followed by lefamulin for 7 days) (1:1 randomisation in the USA). Two additional regimens were also evaluated in Australia: combination therapy with doxycycline plus lefamulin for 7 days and extended lefamulin therapy with doxycycline for 7 days followed by lefamulin for 14 days. Microbiological cure (negative MG NAAT) was assessed 21–35 days after completing lefamulin. Sustained cure was assessed 42–49 days after treatment. Results Seventeen heavily pretreated Australian (seen between October 2020 and December 2023) and 11 US cases (recruited between April 2022 and February 2023; 5 randomised to lefamulin monotherapy, 6 randomised to sequential doxycycline-lefamulin) received lefamulin-containing regimens. Sequential doxycycline-lefamulin demonstrated microbiological cure 21–35 days…
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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.
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