Introduction Due to the potential emergence of cephalosporin-resistant Neisseria gonorrhoeae (NG), some public health agencies recommend a test of cure (TOC) using nucleic acid amplification tests (NAATs). NAATs can remain positive after the infection has been effectively eradicated; the optimal time to obtain a TOC is unclear. To inform TOC recommendations, we conducted NAATs for 21 days following treatment for men who have sex with men (MSM) NG-infected at the urethra, rectum or pharynx.
Methods MSM with untreated urethral, rectal or pharyngeal gonorrhoea were eligible. At enrollment, prior to provision of antibiotics, infection-site specimens were collected by a clinician for culture and NAAT testing. Participants whose enrollment-day specimens were negative were excluded. Participants self-collected daily infection-site specimens (rectal or pharyngeal swabs or urine) for 3 weeks and returned on days 7, 14, and 21 to submit their self-collected specimens for NAAT testing and provide clinician-collected specimens for culture and NAAT testing. We planned to follow at least 10 participants for at least 7 days in each of the urethral (U), rectal (R), and pharyngeal (P) study arms.
Results We enrolled 46 MSM. Eleven participants had negative enrollment-day specimens, and 4 did not return after enrollment. Of the 31 included in the analysis (11U, 11R, 9P), 22 (71%) provided all 21 days of specimens; another 6 provided nearly all study specimens. The majority (94%) were negative on Day 7 (11U, 11R, 7P), though 4 (2U, 1R, 1P) had subsequent positive results.
Conclusion A high proportion of participants had a negative NAAT before antibiotics, despite a prior positive result, indicating either an original false positive result or natural clearance of infection. Additional analyses will determine the effectiveness of other TOC time-points, including median time to: first negative result, 3 consecutive negative results, and clearance (consistently negative results through follow-up); and clearance at Days 14 and 21.
Disclosure of interest statement No pharmaceutical grants were received in the development of this study.