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Streptococcal Infections clinical trials

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NCT ID: NCT04549220 Active, not recruiting - Clinical trials for Group B Strep Infection

Serosurveillance Study of Maternally Derived Anti-GBS Antibody

ProGreSs
Start date: April 24, 2019
Phase:
Study type: Observational

Globally, neonatal mortality remains unacceptably high, with little change in the death rate in the first 28 days of life since 1990, despite reductions in under-5 mortality of up to 50% over the same period. In 2014, neonatal deaths accounted for 44% of all deaths in children under 5 with neonatal infection accounting for over a third of all deaths. Group B Streptococcus (GBS) is a major cause of septicemia and meningitis in infants globally and a cause of severe adverse neurodevelopmental outcomes in up to 50% of meningitis survivors. It can also lead to sepsis in pregnant women. GBS acquisition occurs through vertical transmission in 15%-50% of infants born to a vaginally/rectally colonized mother. Maternal colonization is a prerequisite for early onset (EO) and a risk factor for late onset (LO) disease. Our proposal will provide these critical data in Uganda (a country with high neonatal disease burden) in a 12 month pilot study to determine: the burden of GBS disease in a cohort of mother/infant pairs and establish an active surveillance platform for monitoring of early and late onset neonatal infection in term and preterm infants in Uganda and compare this to the burden known for other African countries. This provides essential data on GBS disease outcomes from a high-HIV burden African cohort reflecting the usual standard of care in a low income, highly deprived urban environment. This pilot study will establish minimum disease estimates in the Ugandan cohort to determine the feasibility of a cohort study over three years to determine the level of antibody against GBS in cord blood from pregnancies where women are GBS colonized and non-colonized but whose infants do not develop GBS disease in the first three months of life and compare this to the level in the blood of infants who develop GBS disease. We will compare these results with those from other African countries such as South Africa to enable a robust estimate of potential sero-correlates of protection from natural infection against the most common GBS-disease-causing serotypes.

NCT ID: NCT04258995 Completed - Clinical trials for Group B Streptococcal Infections

A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS

Start date: February 11, 2020
Phase: Phase 2
Study type: Interventional

This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The study will determine whether individuals who received a primary dose of GBS6 have additional benefit following a booster dose.

NCT ID: NCT04227730 Withdrawn - Clinical trials for Group B Streptococcal Infection

MATERNAL AND NEONATAL SCREENING FOR GROUP B STREPTOCOCCI : A Follow up STUDY

Start date: June 1, 2019
Phase:
Study type: Observational

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%

NCT ID: NCT04222907 Completed - Clinical trials for Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis)

The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel

Start date: January 1, 2015
Phase:
Study type: Observational [Patient Registry]

Determination of GBS colonization rates in Pregnant Women insured with Maccabi Health Services, Doctors' Compliance Rates for Referral for Testing, test execution rates, and Early-onset GBS Disease (EOGBSD) Rates in Israel. Determine the relationship between conducting a GBS test in pregnant women and EOGBSD in Israel.

NCT ID: NCT04116645 Withdrawn - Clinical trials for Group B Streptococcal Infection

Time Frame for GBS Screening

Start date: November 1, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT04100772 Completed - Clinical trials for Bacterial Infections

Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above

PICTPCV13i
Start date: May 18, 2020
Phase: Phase 1
Study type: Interventional

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.

NCT ID: NCT04038073 Recruiting - Clinical trials for Attention Deficit-Hyperactivity Disorder

TLR Polymorphism, ASO and Beta-hemolytic Group A Streptococcus Infections in ADHD: an Observational Study

TLR;
Start date: June 3, 2019
Phase:
Study type: Observational

The aim of this observational cross-sectional study is to evaluate the streptococcal infection (clinical history, ASLO title and anti-DNAse title B) and autoimmunity (ABGA antibodies) in a sample of 100 adult patients diagnosed with ADHD (ie in patients in whom the disorder is permanent). Another objective will be to evaluate the frequency and types of genetic alterations of innate immunity (TLR polymorphisms, MyD88, IRAK-4) that can determine an infantile susceptibility to gram positive infections (ie S. pyogenes, S. pneumoniae, S. aureus) and the possible relationship between these elements, also in relation to comorbidity with other ABGA-related pathologies, to identify a possible pathogenetic immune mechanism of ADHD. Prevalence data will be obtained on an outpatient ADHD population for previous (history) and recent streptococcal infection (ASLO and Anti-DNAsiB), for the detection of ABGA and for the co-presence of other ABGA-related pathologies. By comparing the subgroups obtained by dividing the results on the basis of the positive infectious history, anti-streptococcus, autoantibody and comorbidity titers, it will be possible to assess whether the elevation of the ABGA titer is only linked to the previous/current infection ("infectious" group) or if there is a subpopulation of ADHD patients presenting pathological elevation of ABGA titers in the absence of infectious pictures ("immune" group). Furthermore, it is expected that the comparison of the descriptive polymorphisms TLR, MyD88 and IRAK-4 between the "infectious" and "immune" group may show a predisposition in subjects of the "immune" group.

NCT ID: NCT03976024 Not yet recruiting - Clinical trials for Streptococcus Infection

Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis Mono- or Multi-microbial Streptococcus Beta-haemolytic

STREPTO-FAST
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate streptococcal carriage by swab, pharyngeal, anal and perineal in patients with DHBN-FN, in the entourage living under the same roof as well as patients with erysipelas The main hypothesis is the major role of chronic porting of patients and entourage in DHBN-FN to SBH. Indeed, the chronic pharyngeal / anal / perineal carriage could be a gateway following a transient bacteremia for a DHBN-FN. The transmission of germs from the surrounding to the patient plays a major role: At the gateway level in the case of exogenous DHBN-FN At the origin of chronic carriage in the case of endogenous DHBN-FN Transmission of germs from the patient to the surrounding area also plays an important role in increasing the risk of invasive SBH infections in the surrounding area.

NCT ID: NCT03831269 Not yet recruiting - Clinical trials for Pityriasis Lichenoides

Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin

Start date: February 2019
Phase: N/A
Study type: Interventional

Primary outcome: The primary outcome at end of study (EOS) is to compare the therapeutic efficacy of Azithromycin in the treatment of pityriasis lichenoides chronica (PLC) with that of a well-documented line of therapy namely narrow band ultra violet B (nbUVB). Secondary outcomes: 1. To identify the possibility of streptococcal throat infection as a possible underlying etiology in PLC.

NCT ID: NCT03807245 Completed - Clinical trials for Group B Strep Infection

Group B Streptococcus Vaccine in Healthy Females

MVX0002
Start date: January 9, 2019
Phase: Phase 1
Study type: Interventional

A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.