A Randomized Controlled Trial Comparing the Treatment of Patients Tested for Chlamydia and Gonorrhea After a Rapid Polymerase Chain Reaction Test Versus Standard of Care Testing.

BACKGROUND

We tested the effect of a rapid molecular test for Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG) diagnosis on clinical emergency department decision making compared with standard care. The new test presents an opportunity to improve antibiotic management and patient outcomes.

METHODS

We conducted a randomized controlled trial of 70 consenting patients 18 years or older presenting to an urban emergency department with sexually transmitted infections complaints (vaginal/penile discharge, dysuria, vaginal/penile itching/pain, dyspareunia). Participants were randomized to rapid testing or standard care if a sexually transmitted infection was suspected. Follow-up phone calls were performed 7 to 10 days postdischarge. The primary outcomes included: antibiotic overtreatment rates, partner notification, and health care utilization.

RESULTS

A total of 12.9% tested positive for CT or NG and received antibiotics. Test patients with negative results were less likely to receive empirical antibiotic treatment than control patients, absolute risk difference [RD], 33.4 (95% confidence interval [CI], 7.9%-58.9%), risk ratio [RR], 0.39 (95% CI, 0.19-0.82). Thirty-seven participants (53%) were contacted for follow-up 7 to 10 days postdischarge. Test patients were less likely to report missed antibiotic doses (RD, -51.3%; 95% CI, -84.4% to -18.2%; RR, 0.23; 95% CI, 0.06-0.88). Test patients were more likely to be notified of their results (RD, 50.6%; 95% CI, 22.7%-78.5%; RR, 2.72; 95% CI, 1.26-5.86). There were no significant differences in charges or health care utilization measures.

CONCLUSIONS

We found a significant reduction in unnecessary antibiotic treatment for CT/NG in subjects receiving the rapid molecular test compared with those receiving nucleic acid amplification test.