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Item Azithromycin efficacy in asymptomatic rectal chlamydial infection in MSM: A more definitive answer soon?(Wolters Kluwer, 2017-07) Batteiger, Byron E.; Medicine, School of MedicineItem Azithromycin for Rectal Chlamydia: Is it Time to Leave Azithromycin on the Shelf?...Not Yet(Wolters Kluwer, 2017-02) Jordan, Stephen J.; Geisler, William M.; Medicine, School of MedicineItem Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth(Massachusetts Medical Society, 2023) Tita, Alan T. N.; Carlo, Waldemar A.; McClure, Elizabeth M.; Mwenechanya, Musaku; Chomba, Elwyn; Hemingway-Foday, Jennifer J.; Kavi, Avinash; Metgud, Mrityunjay C.; Goudar, Shivaprasad S.; Derman, Richard; Lokangaka, Adrien; Tshefu, Antoinette; Bauserman, Melissa; Bose, Carl; Shivkumar, Poonam; Waikar, Manju; Patel, Archana; Hibberd, Patricia L.; Nyongesa, Paul; Esamai, Fabian; Ekhaguere, Osayame A.; Bucher, Sherri; Jessani, Saleem; Tikmani, Shiyam S.; Saleem, Sarah; Goldenberg, Robert L.; Billah, Sk M.; Lennox, Ruth; Haque, Rashidul; Petri, William; Figueroa, Lester; Mazariegos, Manolo; Krebs, Nancy F.; Moore, Janet L.; Nolen, Tracy L.; Koso-Thomas, Marion; A-PLUS Trial Group; Pediatrics, School of MedicineBackground: The use of azithromycin reduces maternal infection in women during unplanned cesarean delivery, but its effect on those with planned vaginal delivery is unknown. Data are needed on whether an intrapartum oral dose of azithromycin would reduce maternal and offspring sepsis or death. Methods: In this multicountry, placebo-controlled, randomized trial, we assigned women who were in labor at 28 weeks' gestation or more and who were planning a vaginal delivery to receive a single 2-g oral dose of azithromycin or placebo. The two primary outcomes were a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis. During an interim analysis, the data and safety monitoring committee recommended stopping the trial for maternal benefit. Results: A total of 29,278 women underwent randomization. The incidence of maternal sepsis or death was lower in the azithromycin group than in the placebo group (1.6% vs. 2.4%), with a relative risk of 0.67 (95% confidence interval [CI], 0.56 to 0.79; P<0.001), but the incidence of stillbirth or neonatal death or sepsis was similar (10.5% vs. 10.3%), with a relative risk of 1.02 (95% CI, 0.95 to 1.09; P = 0.56). The difference in the maternal primary outcome appeared to be driven mainly by the incidence of sepsis (1.5% in the azithromycin group and 2.3% in the placebo group), with a relative risk of 0.65 (95% CI, 0.55 to 0.77); the incidence of death from any cause was 0.1% in the two groups (relative risk, 1.23; 95% CI, 0.51 to 2.97). Neonatal sepsis occurred in 9.8% and 9.6% of the infants, respectively (relative risk, 1.03; 95% CI, 0.96 to 1.10). The incidence of stillbirth was 0.4% in the two groups (relative risk, 1.06; 95% CI, 0.74 to 1.53); neonatal death within 4 weeks after birth occurred in 1.5% in both groups (relative risk, 1.03; 95% CI, 0.86 to 1.24). Azithromycin was not associated with a higher incidence in adverse events. Conclusions: Among women planning a vaginal delivery, a single oral dose of azithromycin resulted in a significantly lower risk of maternal sepsis or death than placebo but had little effect on newborn sepsis or death.Item A retrospective comparison of antibiotic regimens for preterm premature rupture of membranes(Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2014-09) Pierson, Rebecca C.; Gordon, Sashana S.; Haas, David M.; Department of Obstetrics & Gynecology, IU School of MedicineOBJECTIVE: To evaluate whether the use of ampicillin and azithromycin leads to a similar latency period in preterm premature rupture of membranes as ampicillin and erythromycin and whether the substitution of azithromycin for erythromycin effects rates of other outcomes. METHODS: We performed a retrospective cohort study of women with preterm premature rupture of membranes between 24 and 34 completed weeks of gestation and compared two groups: those who received ampicillin and erythromycin and those who received ampicillin and azithromycin. Primary outcome was length of latency (defined as time from first antibiotic dose to delivery) and secondary outcomes were rates of chorioamnionitis, cesarean delivery, Apgar scores, birth weight, neonatal death, neonatal sepsis, and neonatal respiratory distress syndrome. RESULTS: Of 168 women who met inclusion criteria, 75 received ampicillin and erythromycin and 93 received ampicillin and azithromycin. There was no difference in latency between groups: 9.6±13.2 days (erythromycin) compared with 9.4±10.0 (azithromycin) days (P=.40). Secondary outcomes did not differ between groups. We had 80% power to detect a difference of 5 days. CONCLUSION: Among women with preterm premature rupture of membranes between 24 and 34 completed weeks of gestation, substitution of azithromycin for erythromycin in the recommended antibiotic regimen did not affect latency or any other measured maternal or fetal outcomes. LEVEL OF EVIDENCE: III.Item A Telehealth-Based Randomized Controlled Trial: A Model for Outpatients Trials of Off-Label Medications During the COVID-19 Pandemic(Sage, 2021-08) Keyhani, Salomeh; Kelly, J. Daniel; Bent, Stephen; Boscardin, W. John; Shlipak, Michael G.; Leonard, Sam; Abraham, Ann; Lum, Emily; Lau, Nicholas; Austin, Charles; Oldenburg, Catherine E.; Zillich, Allan; Lopez, Lenny; Zhang, Ying; Lietman, Tom; Bravata, Dawn M.; Medicine, School of MedicineThe study was registered at clinicaltrials.gov: NCT04363203Item Two Streptococcus pyogenes emm types and several anaerobic bacterial species are associated with idiopathic cutaneous ulcers in children after community-based mass treatment with azithromycin(Public Library of Science, 2022-12-19) Griesenauer, Brad; Xing, Yue; Fortney, Katherine R.; Gao, Xiang; González-Beiras, Camila; Nelson, David E.; Ren, Jie; Mitjà, Oriol; Dong, Qunfeng; Spinola, Stanley M.; Microbiology and Immunology, School of MedicineBackground: In yaws-endemic areas, two-thirds of exudative cutaneous ulcers (CU) are associated with Treponema pallidum subsp. pertenue (TP) and Haemophilus ducreyi (HD); one-third are classified as idiopathic ulcers (IU). A yaws eradication campaign on Lihir Island in Papua New Guinea utilizing mass drug administration (MDA) of azithromycin initially reduced but failed to eradicate yaws; IU rates remained constant throughout the study. Using 16S rRNA gene sequencing, we previously determined that Streptococcus pyogenes was associated with some cases of IU. Here, we applied shotgun metagenomics to the same samples we analyzed previously by 16S rRNA sequencing to verify this result, identify additional IU-associated microorganisms, and determine why S. pyogenes-associated IU might have persisted after MDA of azithromycin. Methodology/principal findings: We sequenced DNA extracted from 244 CU specimens separated into four groups based upon microorganism-specific PCR results (HD+, TP+, TP+HD+, and TP-HD- or IU). S. pyogenes was enriched in IU (24.71% relative abundance [RA]) specimens compared to other ulcer sub-groups, confirming our prior results. We bioinformatically identified the emm (M protein gene) types found in the S. pyogenes IU specimens and found matches to emm156 and emm166. Only ~39% of IU specimens contained detectable S. pyogenes, suggesting that additional organisms could be associated with IU. In the sub-set of S. pyogenes-negative IU specimens, Criibacterium bergeronii, a member of the Peptostreptococcaceae, and Fusobacterium necrophorum (7.07% versus 0.00% RA and 2.18% versus 0.00% RA, respectively), were enriched compared to the S. pyogenes-positive sub-set. Although a broad range of viruses were detected in the CU specimens, none were specifically associated with IU. Conclusions/significance: Our observations confirm the association of S. pyogenes with IU in yaws-endemic areas, and suggest that additional anaerobic bacteria, but not other microorganisms, may be associated with this syndrome. Our results should aid in the design of diagnostic tests and selective therapies for CU.