Browsing by Author "Newman, Lori"

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    2889. One vs Three Weekly Doses of Benzathine Penicillin G for Treatment of Early Syphilis in Persons with and without HIV: A Multicenter Randomized Controlled Trial (RCT)
    (Oxford University Press, 2023-11-27) Hook, Edward W.; Workowski, Kimberly; Dionne, Jodie A.; McNeil, Candice J.; Taylor, Stephanie N.; Batteiger, Teresa; Dombrowski, Julia C.; Mayer, Kenneth H.; Seña, Arlene C.; Wiesenfeld, Harold C.; Perlowski, Charlotte; Newman, Lori; Zhu, Chunming; Mejia-Galvis, Jorge E.; Medicine, School of Medicine
    Background: Syphilis rates in the United Stated (U.S.) have increased steadily for over a decade. Despite over 75 years as the drug of choice for syphilis treatment, controversy persists on optimal duration of therapy with benzathine penicillin G (BPG) for persons with early(primary, secondary, and early latent) syphilis, particularly for persons co-infected with HIV. Given the ongoing national shortages of BPG, optimizing duration of therapy is an urgent concern. Methods: We conducted a multicenter RCT comparing a single intramuscular (IM) injection of BPG, 2.4 million units to BPG administered for three successive weeks for treatment of early syphilis in persons with and without HIV. The primary outcome of the study was a > 4-fold decline in RPR titer measured at 6 months. Intention to treat (ITT) and per protocol analyses were performed and were similar. ITT analyses are presented here. Results: A total of 249 persons with early syphilis were enrolled at 10 participating sites. Most (97%) participants were were categorized as male sex, black race (62%), and 153 (64%) were living with HIV. The syphilis stage distribution was 19% primary, 47% secondary, and 33% early latent and did not differ significantly by HIV status. Serologic response (> 4-fold decline in RPR titer) at 6 months was 76% (95% Confidence Interval (CI) 0.68-0.82) in the single dose group and did not differ significantly from the three-dose group (70%, 95% CI 0.61-0.77). There were no treatment failures (> 4-fold increase in RPR titer). Among persons with and without HIV there was no significant difference in RPR response at 6 months: 76% in the single-dose group vs. 71% in the 3-dose group (95% CI 0.05-0.17). Most participants experienced mild to moderate local injection site pain and tenderness. Conclusion: Treatment of persons with early syphilis with more than a single dose of 2.4 million units of BPG offers no therapeutic benefit irrespective of HIV infection status and was associated with increased rates of injection site discomfort.
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    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 Medicine
    Among 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.
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    Randomized Multicenter Trial for the Validation of an Easy-to-Administer Algorithm to Define Penicillin Allergy Status in Sexually Transmitted Infection Clinic Outpatients
    (Oxford University Press, 2024) Lillis, Rebecca A.; Barbee, Lindley A.; McNeil, Candice J.; Newman, Lori; Fortenberry, J. Dennis; Alvarez-Arango, Santiago; Zenilman, Jonathan M.; Pediatrics, School of Medicine
    Background: Approximately 15% of patients in sexually transmitted infection (STI) clinics report penicillin allergies, complicating treatment for syphilis and gonorrhea. Nonetheless, >90% do not have a penicillin allergy when evaluated. We developed and validated an algorithm to define which patients reporting penicillin allergy can be safely treated at STI clinics with these drugs. Methods: Randomized controlled trial to assess feasibility and safety of penicillin allergy evaluations in STI clinics. Participants with reported penicillin allergy answered an expert-developed questionnaire to stratify risk. Low-risk participants underwent penicillin skin testing (PST) followed by amoxicillin 250 mg challenge or a graded oral challenge (GOC)-amoxicillin 25 mg followed by 250 mg. Reactions were recorded, and participant/provider surveys were conducted. Results: Of 284 participants, 72 (25.3%) were deemed high risk and were excluded. Of 206 low-risk participants, 102 (49.5%) underwent PST without reactions and 3 (3%) had mild reactions during the oral challenge. Of 104 (50.5%) participants in the GOC, 95 (91.3%) completed challenges without reaction, 4 (4.2%) had mild symptoms after 25 mg, and 4 (4.2%) after 250-mg doses. Overall, 195 participants (94.7%) successfully completed the study and 11 (5.3%) experienced mild symptoms. Of 14 providers, 12 (85.7%) completed surveys and 11 (93%) agreed on the safety/effectiveness of penicillin allergy assessment in STI clinics. Conclusions: An easy-to-administer risk-assessment questionnaire can safely identify patients for penicillin allergy evaluation in STI clinics by PST or GOC, with GOC showing operational feasibility. Using this approach, 67% of participants with reported penicillin allergy could safely receive first-line treatments for gonorrhea or syphilis.