Abstract
Background: Gonorrhoea is a common sexually transmitted infection for which ceftriaxone is the current first line treatment, but antimicrobial resistance is emerging. The objective of this study was to assess the effectiveness of gentamicin as an alternative to ceftriaxone (both combined with azithromycin) for treatment of gonorrhoea.
Methods: We performed a blinded, non-inferiority randomised trial in 14 sexual health clinics in England. Adults with a diagnosis of uncomplicated genital, pharyngeal or rectal gonorrhoea were randomised using a secure web based system, stratified by clinic. Allocation was either to gentamicin 240 mg or to ceftriaxone 500 mg, both administered as a single intramuscular injection. All participants also received 1 g oral azithromycin. The primary outcome was clearance of Neisseria gonorrhoeae at all infected sites.
Findings: We enrolled 720 participants and randomly assigned them to gentamicin (n=358) or ceftriaxone (n=362), with 292 and 306, respectively, included in the primary analysis. Non-inferiority of gentamicin to ceftriaxone was not demonstrated (adjusted risk difference for microbiological clearance -6.4%, 95% CI -10.4%, -2.4%, NI margin -5%). Clearance of genital infection was similar in the two groups: 94% gentamicin versus 98% ceftriaxone: but for pharyngeal and rectal infections were lower in the gentamicin group (80% vs 96% and 90% vs 98%, respectively). The side effect profiles were comparable between the allocated groups, other than reported pain at the injection site, which was higher for gentamicin.
Interpretation: Gentamicin is not an appropriate alternative first line treatment for gonorrhoea, but remains potentially useful for patients with isolated genital infection, or who are allergic/intolerant to ceftriaxone, or harbour a ceftriaxone resistant isolate. Further research is required to identify and test new alternatives to ceftriaxone for the treatment of gonorrhoea.
Funding: NIHR Health Technology Assessment Programme
Methods: We performed a blinded, non-inferiority randomised trial in 14 sexual health clinics in England. Adults with a diagnosis of uncomplicated genital, pharyngeal or rectal gonorrhoea were randomised using a secure web based system, stratified by clinic. Allocation was either to gentamicin 240 mg or to ceftriaxone 500 mg, both administered as a single intramuscular injection. All participants also received 1 g oral azithromycin. The primary outcome was clearance of Neisseria gonorrhoeae at all infected sites.
Findings: We enrolled 720 participants and randomly assigned them to gentamicin (n=358) or ceftriaxone (n=362), with 292 and 306, respectively, included in the primary analysis. Non-inferiority of gentamicin to ceftriaxone was not demonstrated (adjusted risk difference for microbiological clearance -6.4%, 95% CI -10.4%, -2.4%, NI margin -5%). Clearance of genital infection was similar in the two groups: 94% gentamicin versus 98% ceftriaxone: but for pharyngeal and rectal infections were lower in the gentamicin group (80% vs 96% and 90% vs 98%, respectively). The side effect profiles were comparable between the allocated groups, other than reported pain at the injection site, which was higher for gentamicin.
Interpretation: Gentamicin is not an appropriate alternative first line treatment for gonorrhoea, but remains potentially useful for patients with isolated genital infection, or who are allergic/intolerant to ceftriaxone, or harbour a ceftriaxone resistant isolate. Further research is required to identify and test new alternatives to ceftriaxone for the treatment of gonorrhoea.
Funding: NIHR Health Technology Assessment Programme
| Original language | English |
|---|---|
| Pages (from-to) | 2511-2520 |
| Number of pages | 10 |
| Journal | The Lancet |
| Volume | 393 |
| Issue number | 10190 |
| Early online date | 2 May 2019 |
| DOIs | |
| Publication status | Published - Jun 2019 |