View clinical trials related to Group B Streptococcal Infection.
Filter by:A placebo controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants
This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women. There will be 5 treatment groups; three groups of 60 participants will receive will receive two doses of GBS-NN/NN2 vaccine and one dose of placebo (saline); one group of 60 participants will receive one dose of GBS-NN/NN2 vaccine and two doses of placebo (saline), and one group of 60 participants will receive three doses of placebo (saline).
A randomised, placebo-controlled, double-blind study to evaluate the safety, tolerability and immunogenicity of the GBS-NN/NN2 (Recombinant protein vaccine against Group B Streptococcus) vaccine in women living with HIV and women without HIV,and their newborn babies from vaccination up to delivery/birth. Mothers and babies will be followed up for 6 months post-delivery.
Group B Streptococcus (GBS), is a facultative gram positive diplococcus originally known for causing bovine mastitis and was not demonstrated to be a human pathogen until 1938. In the 1970s, GBS emerged as the leading cause of neonatal morbidity and mortality, with a frequency of 2-3 cases per 1,000 live births and case-fatality ratios as high as 50%
All pregnant women prenatally being followed up or admitted at Rambam HealthCare Campus, Haifa, Israel are potential participants in the study. If a patient is agreeable, the nurse/physician/research coordinator will obtain informed consent. Once informed consent is obtained, the patient can be swabbed for GBS. The swabs will be obtained at the routine follow-up at the clinic at 30, 32 and 35 weeks' gestation. If a patient is found to have a positive GBS culture at 35 weeks, she will receive antibiotic treatment during labour according to the protocol. GBS swabs taken at delivery will be compared to previous swabs taken at an earlier gestational age in order to evaluate sensitivity, specificity, positive and negative predictive values of GBS swabs at each week of gestation and to determine the value of our primary hypothesis.
The aim of this project is to identify the duration of vancomycin administration at which group B streptococcus (GBS) colonization is eradicated from the vaginal and recto-vaginal mucosa. This will aid in labor management and delivery planning to ensure that the mother receives adequate GBS prophylaxis while also minimizing the duration of exposure to vancomycin. In addition, this could prevent unnecessary prolonged hospitalization or septic workup of neonates whose mothers received vancomycin intrapartum. This study aims to identify the time after administration of IV vancomycin at which GBS colonies are 100% eradicated.
Group B Streptococcus (GBS) is the leading cause of neonatal morbidity and mortality in Canada. It may be passed from a study participant colonized in the genital tract by GBS to their baby during vaginal birth. While approximately 10 to 30% of pregnant people harbour GBS in the vagina or rectum, the incidence of neonatal GBS disease is 1 to 2 infants per 1000 births. The use of intrapartum antibiotics to treat colonized individuals with or without risk factors has led to a 70% decline in the incidence of early-onset GBS sepsis in the past decade. Despite this impressive decline, antibiotic resistance has become a major public health concern. Association between intrapartum antibiotic use and ampicillin resistance in E. coli isolated from neonates has previously been documented. Furthermore, while GBS has remained sensitive to penicillin, 20% are resistant to erythromycin and clindamycin, which are alternate drugs for patients allergic to penicillin. Alternative approaches are therefore needed to reduce the risk of GBS infection. We therefore propose to study the use of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 (Lactobacillus fermentum RC-14) in the colonization status of GBS in pregnant people. Lactobacilli are part of normal gut and vaginal flora and have been widely used as probiotics to treat various conditions. In particular, these two strains have shown to be beneficial in the treatment of urinary tract infections and bacterial vaginosis. Our study design involves recruiting two hundred pregnant people (one hundred in each arm) through various midwifery practices in the GTA at the end of their first trimester of pregnancy. These individuals will be randomized to receive probiotics or placebo for twelve weeks of their pregnancies and will be cultured before delivery to determine their colonization status. The capsules with probiotics and placebo will be provided free of charge. The study design was chosen to minimize the cost and clients' visits to the clinic as vaginal/rectal swabs are routinely offered at 35-37 weeks of gestation.
1. At the University Hospital Basel, Switzerland, a simplified screening for group B streptococci (GBS) of vagina and perineum has been performed since several years. Reliable detection of GBS is critical to prevent GBS transmission during delivery with antimicrobial prophylaxis. Transmission of GBS to the neonate may otherwise lead to severe infection and complications in the neonate. Centers for Disease Control and Prevention (CDC) and other international organizations recommend a vaginal and additional rectal swab.We therefore aim to test this simplified screening against the international gold standard. 2. Antibiotic resistant bacteria may reside in the genital tract of an expected mother and may be transmitted to the new-born during delivery. In case of infection of the pregnant woman or the neonate, application of standard antimicrobial treatment will insufficiently cover these extended spectrum beta-lactamase (ESBL) producing bacteria. Therefore, colonization with ESBL in pregnancy needs to be known to potentially deliver adequate antimicrobial treatment.
The purpose of this study is to examine whether daily use of oral gelatin capsules containing dried viable Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 can reduce the GBS colonization rate of vagina and rectum in pregnant women who present with GBS-positive diagnosed by GBS culture at 35-37 weeks gestation. This study is a prospective double blind randomized clinical trial. Vaginal and rectal GBS screening culture are carried out for all pregnant women at 35-37 weeks of gestation in our out-patient department. Subjects with vagina and rectum GBS colonization are invited to participate in our study after informed consent. A total of 200 pregnant women will participate in the study during the 12-months trial period. They are randomly assigned to one of the two groups. The study group is treated with two oral capsules of probiotics once daily (before sleeping) for 14 days, and the control group will take 2 capsules of placebos. Vaginal and rectal GBS culture is repeated for all participators 2 weeks later. All participators will treated according to GBS guideline by CDC in 2002 during laboring.