Journal article

Solithromycin versus ceftriaxone plus azithromycin for the treatment of uncomplicated genital gonorrhoea (SOLITAIRE-U): a randomised phase 3 non-inferiority trial

Marcus Y Chen, Anna McNulty, Ann Avery, David Whiley, Sepehr N Tabrizi, Dwight Hardy, Anita F Das, Ashley Nenninger, Christopher K Fairley, Jane S Hocking, Catriona S Bradshaw, Basil Donovan, Benjamin P Howden, David Oldach

The Lancet Infectious Diseases | ELSEVIER SCI LTD | Published : 2019

Abstract

BACKGROUND: Antibiotic-resistant gonorrhoea represents a global public health threat, and new therapies are needed. We aimed to compare the efficacy and safety of solithromycin, a fourth generation macrolide, with ceftriaxone plus azithromycin for the treatment of gonorrhoea. METHODS: We did an open-label, multicentre, non-inferiority trial of patients aged 15 years or older with uncomplicated untreated genital gonorrhoea at two sites in Australia and one site in the USA. Patients were randomly assigned (1:1) to receive single dose oral solithromycin 1000 mg or intramuscular ceftriaxone 500 mg plus oral azithromycin 1000 mg. Neisseria gonorrhoeae cultures were obtained at baseline and test o..

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