Browsing by Subject "Gonorrhea"
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Item Clinical Performance of the BD CTGCTV2 Assay for the BD MAX System for Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis Infections(Wolters Kluwer, 2021) Van Der Pol, Barbara; Torres-Chavolla, Edith; Kodsi, Salma; Cooper, Charles K.; Davis, Thomas E.; Fife, Kenneth H.; Taylor, Stephanie N.; Augenbraun, Michael H.; Gaydos, Charlotte A.; Medicine, School of MedicineBackground: Diagnostic options to combat the increasing rates of sexually transmitted infections recorded throughout the world increasingly include multiplex assays. Here we describe the estimated sensitivity and specificity of a triplex molecular assay that simultaneously detects Chlamydia trachomatis (CT), Neisseria gonorrhoeae (or gonococci [GC]), and Trichomonas vaginalis (TV). Methods: Participants (2547 women and 1159 men) were recruited from 12 clinics in the United States. BD CTGCTV2 for BD MAX System assay (CTGCTV2) results were obtained from vaginal and endocervical swabs, endocervical samples in cytology medium, and female and male urine. Results were compared with infection standards that were sample type and pathogen dependent. Results: Female specimen sensitivity estimates ranged from 92.7% to 98.4%, 92.9% to 100%, and 86.6% to 100% for CT, GC and TV, respectively. Male urine sensitivity estimates were 96.7%, 99.2%, and 97.9% for CT, GC, and TV, respectively. Specificity estimates were >98.7% for all sample types. Conclusions: BD CTGCTV2 performed well using a variety of sample types. As a true triplex assay, performed using a benchtop instrument, BD CTGCTV2 may be useful in settings where no testing is currently performed and in settings, such as reference laboratories, where testing turnaround time may be several days. Use of this assay at local laboratories may result in greater access to testing and a shorter time to result, which are important steps for improving our ability to combat sexually transmitted infections.Item Coinfection with Chlamydial and Gonorrheal Infection among US Adults with Early Syphilis(Wolters Kluwer, 2022) Dionne-Odom, Jodie; Workowski, Kimberly; Perlowski, Charlotte; Taylor, Stephanie N.; Mayer, Kenneth H.; McNeil, Candice J.; Hamill, Matthew M.; Dombrowski, Julia C.; Batteiger, Teresa A.; Sena, Arlene C.; Wiesenfeld, Harold C.; Newman, Lori; Hook, Edward W., III; Medicine, School of MedicineAmong 865 adults with early syphilis considered for a multicenter treatment trial, 234 (27%) were excluded before enrollment because of bacterial sexually transmitted infection coinfection. Coinfection with Neisseria gonorrhoeae (29%), Chlamydia trachomatis (22%), or both (23%) was common. Study findings highlight the need for comprehensive bacterial sexually transmitted infection screening in patients with syphilis.Item Findings From a Scoping Review: Presumptive Treatment for Chlamydia trachomatis and Neisseria gonorrhoeae in the United States, 2006–2021(American Sexually Transmitted Diseases Association, 2023-04) Allen, Katie S.; Hinrichs, Rachel J.; Heumann, Christine L.; Titus, Melissa K.; Duszynski, Thomas J.; Valvi, Nimish R.; Wiensch, Ashley; Tao, Guoyu; Dixon, Brian E.Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are the 2 most common reported sexually transmitted infections in the United States. Current recommendations are to presumptively treat CT and/or GC in persons with symptoms or known contact. This review characterizes the literature around studies with presumptive treatment, including identifying rates of presumptive treatment and overtreatment and undertreatment rates. Of the 18 articles that met our inclusion criteria, 6 pertained to outpatient settings. In the outpatient setting, presumptive treatment rates, for both asymptomatic and symptomic patients, varied from 12% to 100%, and the percent positive of those presumptively treated ranged from 25% to 46%. Three studies also reported data on positive results in patients not presumptively treated, which ranged from 2% to 9%. Two studies reported median follow-up time for untreated, which was roughly 9 days. The remaining 12 articles pertained to the emergency setting where presumptive treatment rates, for both asymptomatic and symptomic patients, varied from 16% to 91%, the percent positive following presumptive treatment ranged from 14% to 59%. Positive results without presumptive treatment ranged from 4% to 52%. Two studies reported the percent positive without any treatment (6% and 32%, respectively) and one reported follow-up time for untreated infections (median, 4.8 days). Rates of presumptive treatment, as well as rates of overtreatment or undertreatment vary widely across studies and within care settings. Given the large variability in presumptive treatment, the focus on urban settings, and minimal focus on social determinants of health, additional studies are needed to guide treatment practices for CT and GC in outpatient and emergency settings.Item Findings From a Scoping Review: Presumptive Treatment for Chlamydiatrachomatis and Neisseria gonorrhoeae in the United States, 2006-2021(Wolters Kluwer, 2023) Allen, Katie S.; Hinrichs, Rachel; Heumann, Christine L.; Titus, Melissa K.; Duszynski, Thomas J.; Valvi, Nimish R.; Wiensch, Ashley; Tao, Guoyu; Dixon, Brian E.; University LibraryChlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are the two most common reported sexually transmitted infections in the USA. Current recommendations are to presumptively treat CT and/or GC in persons with symptoms or known contact. This review characterizes the literature around studies with presumptive treatment, including identifying rates of presumptive treatment and over- and under-treatment rates. Of the 18 articles that met our inclusion criteria, six pertained to outpatient settings. In the outpatient setting, presumptive treatment rates, for both asymptomatic and symptomic patients, varied from 12% - 100%, and the percent positive of those presumptively treated ranged from 25% - 46%. Three studies also reported data on positive results in patients not presumptively treated, which ranged from 2% - 9%. Two studies reported median follow-up time for untreated, which was roughly nine days. The remaining 12 articles pertained to the emergency setting where presumptive treatment rates, for both asymptomatic and symptomic patients, varied from 16% - 91%, the percent positive following presumptive treatment ranged from 14% - 59%. Positive results without presumptive treatment ranged from 4% - 52%. Two studies reported the percent positive without any treatment (6% and 32% respectively) and one reported follow-up time for untreated infections (median: 4.8 days). Rates of presumptive treatment, as well as rates of over- or under- treatment vary widely across studies and within care settings. Given large variability in presumptive treatment, the focus on urban settings, and minimal focus on social determinants of health, additional studies are needed to guide treatment practices for CT and GC in outpatient and emergency settings.Item Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: A Phase 2, Randomized, Dose-Ranging, Single-Oral Dose Evaluation(Oxford University Press, 2018-08-01) Taylor, Stephanie N.; Morris, David H.; Avery, Ann K.; Workowski, Kimberly A.; Batteiger, Byron E.; Tiffany, Courtney A.; Perry, Caroline R.; Raychaudhuri, Aparna; Scangarella-Oman, Nicole E.; Hossain, Mohammad; Dumont, Etienne F.; Medicine, School of MedicineBackground: In this phase 2 study, we evaluated the efficacy and safety of oral gepotidacin, a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor, for the treatment of uncomplicated urogenital gonorrhea. Methods: Adult participants with suspected urogenital gonorrhea were enrolled and completed baseline (day 1) and test-of-cure (days 4-8) visits. Pretreatment and posttreatment urogenital swabs were collected for Neisseria gonorrhoeae (NG) culture and susceptibility testing. Pharyngeal and rectal swab specimens were collected if there were known exposures. Participants were stratified by gender and randomized 1:1 to receive a 1500-mg or 3000-mg single oral dose of gepotidacin. Results: The microbiologically evaluable population consisted of 69 participants, with NG isolated from 69 (100%) urogenital, 2 (3%) pharyngeal, and 3 (4%) rectal specimens. Microbiological eradication of NG was achieved by 97%, 95%, and 96% of participants (lower 1-sided exact 95% confidence interval bound, 85.1%, 84.7%, and 89.1%, respectively) for the 1500-mg, 3000-mg, and combined dose groups, respectively. Microbiological cure was achieved in 66/69 (96%) urogenital infections. All 3 failures were NG isolates that demonstrated the highest observed gepotidacin minimum inhibitory concentration of 1 µg/mL and a common gene mutation. At the pharyngeal and rectal sites, 1/2 and 3/3 NG isolates, respectively, demonstrated microbiological cure. There were no treatment-limiting adverse events for either dose. Conclusions: This study demonstrated that single, oral doses of gepotidacin were ≥95% effective for bacterial eradication of NG in adult participants with uncomplicated urogenital gonorrhea.Item Gonorrhea testing, morbidity, and reporting using an integrated sexually transmitted disease registry in Indiana: 2004-2016(Sage, 2021-01) Ojo, Opeyemi C.; Arno, Janet N.; Tao, Guoyu; Patel, Chirag G.; Zhang, Zuoyi; Wang, Jane; Holderman, Justin; Dixon, Brian E.; Medicine, School of MedicineBackground: Surveillance of gonorrhea (GC), the second most common notifiable disease in the United States, depends on case reports. Population-level data that contain the number of individuals tested in addition to morbidity are lacking. Methods: We performed a cross-sectional analysis of data obtained from individuals tested for GC recorded in a STD registry. Descriptive statistics were performed, and a Poisson generalized linear model was used to evaluate the number of individuals tested for GC and the positivity rate. GC cases from a subset of the registry was compared to CDC to determine the completeness of the registry. Results: A total of 1,870,811 GC tests were linked to 627,870 unique individuals. Individuals tested for GC increased from 54,334 in 2004 to 269,701 in 2016; likewise, GC cases increased from 2,039 to 5,997. However, positivity rate decreased from 3.75% in 2004 to 2.22% in 2016. The difference in the number of GC cases captured by the registry and those reported to the CDC were not statistically significant (P= 0.0665). Conclusions: Population-level data from a STD registry combining electronic medical records and public health case data may inform STD control efforts. In Indiana, increased testing rates appeared to correlate with increased GC morbidity.