Chorioamnionitis

FRIDAY, Sept. 20, 2024 -- Influenza vaccination in successive pregnancies is not associated with increased risk for prespecified adverse perinatal outcomes, according to a study published online Sept. 19 in JAMA Network Open . Darios Getahun, M.D., Ph.D., M.P.H., from Kaiser Permanente Southern California in Pasadena, and colleagues conducted a retrospective cohort study involving individuals with at least two successive singleton live-birth pregnancies to examine the association between seasonal influenza vaccination across successive pregnancies and adverse perinatal outcomes. Data were included for 82,055 people with singleton pregnancies between Jan. 1, 2004, and Dec. 31, 2018. Overall, 54.7 percent of the participants had influenza vaccination in successive pregnancies. The researchers found that vaccination in successive pregnancies was not associated with increased risks for preeclampsia or eclampsia, placental abruption, fever, preterm birth, preterm premature rupture of membranes, chorioamnionitis, or small-for-gestational-age birth compared with individuals not vaccinated in both pregnancies. The observed associations were not modified by interpregnancy intervals or vaccine type. "The study findings support recommendations to vaccinate people during pregnancy regardless of the interval between any two successive pregnancies and the type of vaccination," the authors write. Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

FRIDAY, July 12, 2024 -- Five cases of neonatal enterovirus infection have been reported in San Diego, highlighting the risks and need for timely identification and treatment, according to data published in the July 11 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report . Ryan Sanchez, M.D., from the University of California, San Diego, and colleagues describe five cases of neonatal enterovirus infection identified at Rady Children's Hospital in San Diego. The researchers note that based on characteristic clinical presentations during enterovirus seasons, all five cases were initially suspected to be caused by enterovirus, which was supported by positive rhinovirus-enterovirus results from respiratory virus panel testing of nasopharyngeal specimens. For four of the five patients, plasma tested positive for enterovirus by reverse transcription-polymerase chain reaction (RT-PCR). Two patients had positive RT-PCR testing of cerebrospinal fluid for enterovirus. Four and three infants had thrombocytopenia and hepatitis with coagulopathy, respectively. In three neonates, serum ferritin levels were elevated. Seizures were the initial sign in one neonate, who subsequently developed pancytopenia with suspected, but unconfirmed, viral-induced hemophagocytic lymphohistiocytosis. The most severely affected patient, aged 5 days, developed multiorgan failure; his mother experienced a febrile illness during delivery, which was diagnosed as chorioamnionitis. The infant received multiple immune globulin intravenous (IGIV) doses, the investigational drug pocapavir, and maternal convalescent plasma, but did not survive. Four of the infants received IGIV therapy. Mothers of three infants were diagnosed with chorioamnionitis before delivery and the mother of the remaining two infants received a diagnosis of endometritis. "Timely identification facilitates optimal clinical management for the infant, which might include receipt of IGIV and possibly antiviral medication," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

SUZHOU, China--(BUSINESS WIRE)-- Suzhou OSAI Biopharma, Inc., a biopharmaceutical company focused on developing live biotherapeutic products (LBPs), today announced that its Phase III clinical trial of vaginal L. crispatus live bacteria capsule (Lc262-1) has successfully met its primary and secondary endpoints. The Phase III study was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 320 patients with bacterial vaginosis (BV). After receiving seven days of oral metronidazole and vaginal LBP/placebo combination therapy, the cured patients were followed up for three months. The results from the treatment group were superior to the placebo group on the primary and secondary endpoints, with statistically significant differences between the two groups. In terms of safety, there was no difference in the incidence of adverse events or adverse reactions between the two groups. “The prevention of recurrent infection is critical in treating gynecological infections,” said Prof. Liu Zhaohui, MD, the principal investigator of the study and vice-chair of the Infection Working Group of the Chinese Medical Association's Department of Obstetrics and Gynecology, Capital Medical University Affiliated Beijing Obstetrics and Gynecology Hospital. “In China, more than 70 million BV cases are reported annually, with a 12-month recurrence rate of up to 60%. Currently, there are very limited effective treatments available. The positive results of this Phase III clinical trial have demonstrated the efficacy of L. crispatus in suppressing BV recurrence, providing patients with a new treatment option.” “Vaginal L. crispatus live bacteria capsule is a novel Live Biotherapeutic Product (LBP) that aims to restore healthy vaginal microbiota by using L. crispatus to prevent and reduce the recurrence of vaginal infections,” said Dr. Liu Yang, co-founder and chief scientific officer of Suzhou OSAI Biopharma. “This Phase III clinical trial is the first registrational Phase III clinical trial globally to evaluate the efficacy of L. crispatus in reducing BV recurrence under a rigorous clinical design. The observed data is encouraging, our team is committed to continuing to advance the program in regulatory registration and further expand our LBP pipeline.” About Vaginal L. crispatus Live Bacteria Capsule Vaginal L. crispatus live bacteria capsule is a first-in-class, innovative LBP developed by Suzhou OSAI Biopharma, utilizing live L. crispatus bacteria to restore the balance of the vaginal microbiome. L. crispatus is the most common and dominant bacteria in the vaginas of healthy Chinese women of childbearing age. The presence and enrichment of L. crispatus in the vaginal environment is considered a marker of healthy vaginal microbiota. L. crispatus can suppress the growth of other microorganisms through various mechanisms, such as maintaining a weakly acidic environment in the vagina by producing lactic acid, producing hydrogen peroxide, competing for nutrients (such as glycogen), occupying space (by competing for adhesion to vaginal epithelial cells) and stimulating local vaginal immunity. In recognition of the important role of L. crispatus in maintaining vaginal health, Suzhou OSAI Biopharma selected a strain of L. crispatus, Lc262-1, from the vaginal microbiota of healthy Chinese women. Leveraging its proprietary “Natural Microbiome Drug Development Platform,” the company developed a highly stable live bacteria capsule. About Bacterial Vaginosis Bacterial vaginosis (BV) is a common vaginal infection in women of childbearing age. It is caused by an overgrowth of anaerobic bacteria in the vagina. In China, there are over 70 million cases of BV each year. The recurrence rate of BV is high, roughly 20% within one month of treatment, 40% within three months of treatment, and 60% within 12 months of treatment. BV can also lead to pelvic inflammatory disease, post-surgical infections after gynecological surgery, and infertility. BV in pregnancy can lead to miscarriage, preterm birth, premature rupture of membranes, chorioamnionitis, neonatal infection, and postpartum infection. BV can also increase the risk of sexually transmitted infections (STIs), such as those caused by HPV, HIV, Neisseria gonorrhoeae, Chlamydia trachomatis, and herpes simplex virus type 2. About Suzhou OSAI Biopharma Founded in 2011, Suzhou OSAI Biopharma is a biopharmaceutical company focused on the research and development of LBPs. The company has built its own proprietary "Natural Microbiome Drug Development Platform" since its inception, with patents covering the Greater China Area, United States, Europe, Japan, South Korea, and Southeast Asia. OSAI Biopharma is committed to the research and development of LBPs to restore the healthy balance of human microbiome. Its lead asset, live L. crispatus capsule, has completed a Phase III clinical trial and demonstrated significant potential in the treatment and prevention of BV related to microbiota dysbiosis. OSAI Biopharma anticipates applying for Biologics License Applications (BLA) of its vaginal L. crispatus capsule to the China NMPA’s Center of Drug Evaluation (CDE) in the near future.