Journal article

Lefamulin for Mycoplasma genitalium treatment failure in Australia and the USA: A case series and pilot open-label parallel arm randomised trial

MS Ramchandani, EL Plummer, A Parker, LA Vodstrcil, OO Soge, I Aguirre, J Kim, JP Hughes, LA Barbee, JS Jensen, LE Manhart, CS Bradshaw

Sexually Transmitted Infections | Published : 2025

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 ..

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Grants

Awarded by Nabriva Therapeutics


Funding Acknowledgements

Nabriva Therapeutics provided study drug to both sites. The US study was supported by an investigator-initiated research grant from Nabriva Therapeutics, Ltd. to LEM. CSB funded the Australian study and investigators from a National Health and Medical Research Council Investigator Grant (APP 1173361).