This study looked at whether a single 1000mg dose of solithromycin was a suitable first line treatment for gonorrhoea compared with standard therapy.
We did an open-label, multicentre, non-inferiority trial of patients aged 15 years or older with uncomplicated untreated genital gonorrhoea. 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 of cure
The study found a single 1000mg dose of solithromycin was not suitable first line treatment for gonorrhoea compared with standard therapy. Would a slightly longer dose have improved the cure rate? We don’t know. This would need to be studied in another trial. However, gastrointestinal side effects were already high with the 1000mg dose.
Publications
SOLITAIRE-U: A Phase 3 randomized trial comparing single dose oral Solithromycin versus single dose intramuscular ceftriaxone plus single dose oral azithromycin for treatment of uncomplicated genital gonorrhoea
Chen MY, McNulty A, Avery A, Whiley D, Tabrizi SN, Hardy D, Das AF, Nenninger A, Fairley CK, Hocking JS, Bradshaw CS, Donovan B, Howden BP, Oldach D
(2019), The Lancet Infectious Diseases,