Efficacy of ertapenem, gentamicin, fosfomycin, and ceftriaxone for the treatment of anogenital gonorrhoea (NABOGO): a randomised, non-inferiority trial
In RCT (n=346; Amsterdam), a single-dose 1000 mg ertapenem was non-inferior to single-dose 500 mg ceftriaxone but 5 mg/kg gentamicin (maximum 400 mg) was not non-inferior to ceftriaxone, suggesting ertapenem may be a potential effective alternative for anogenital N gonorrhoeae.
Source:
The Lancet Infectious Diseases
SPS commentary:
In the primary per-protocol analysis, 93 (100%) of 93 patients in the ceftriaxone group, 86 (99%) of 87 patients in the ertapenem group, 79 (93%) of 85 patients in the gentamicin group, and four (12%) of 33 patients in the fosfomycin group cleared N gonorrhoeae (risk difference vs ceftriaxone −0·01 [95% CI −0·08 to 0·05] for ertapenem and −0·07 [−0·16 to −0·01] for gentamicin). The fosfomycin group was terminated early after interim analysis revealed less than 60% efficacy.
According to a commentary it was disappointing that the only oral treatment evaluated, fosfomycin, performed so badly and 87% had diarrhoea and unfortunate that the trial does not provide any optimism for pharyngeal N gonorrhoeae treatment, with none meeting the CDC efficacy criteria. It suggest that these data provide RCT evidence that ertapenem is another potential treatment for N gonorrhoeae, but it is likely to remain as a rescue therapy only. It notes widespread implementation of sensitive and specific molecular assays for detecting N gonorrhoeae susceptibility will help protect ceftriaxone. It calls for further RCTs of treatment for pharyngeal N gonorrhoeae, as all too often, this is a secondary outcome with small sample size and efficacy estimates at risk of bias and confounding.