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NCT ID: NCT03361163 Completed - Clinical trials for Bacterial Infections

Controlled Human Infection for Vaccination Against Streptococcus Pyogenes

CHIVAS
Start date: July 10, 2018
Phase: Phase 1
Study type: Interventional

Group A Streptococcus (GAS) infection is a major cause of death and disability globally with a disproportionately high burden in settings of disadvantage worldwide. Acute infections due to GAS range from very common superficial skin infections (>150 million prevalent cases) and pharyngitis (over 600 million incident cases) to life-threatening invasive disease (>600,000 incident cases) such as necrotising fasciitis. Post-infectious GAS sequelae of GAS include acute rheumatic fever (ARF, ~500,000 incident cases) leading to rheumatic heart disease (RHD, ~34 million prevalent cases), and acute glomerulonephritis. The health services impact of GAS disease in all its forms is immense and strikes at every level from primary to intensive care. Controlled human infection models (CHIMs) have a long history of critical contributions to vaccine development. Data from CHIMs meeting modern scientific, regulatory, and ethical standards, are aiding efforts to control over 25 major human pathogens, including bacteria (e.g. pneumococcus, cholera), viruses (e.g. respiratory syncytial virus, influenza), and parasites (e.g. malaria, schistosomiasis). A reliable and safe controlled human infection model of GAS pharyngitis will be an important part of the global vaccine development effort. To build the model, the investigators are undertaking a dose-ranging study using an observational, dose-escalation, inpatient trial to determine the dose of GAS administered by direct oropharyngeal inoculation (bacteria 'painted' onto throat) required to reliably produce a pharyngitis attack rate of ≥ 60% in carefully screened healthy adult volunteers.

NCT ID: NCT03360877 Completed - Clinical trials for Severe Acute Malnutrition

Prevention of Nosocomial Infections (CleanKids)

CleanKids
Start date: September 5, 2016
Phase: N/A
Study type: Interventional

While the standardization of treatment protocols for Severe Acute Malnutrition (SAM) has helped to reduce historically high mortality, mortality in inpatient settings remains substantial, likely due to the severity of complications associated with late presentation and health-care associated infection (HCAI). The purpose of this study is to serve as an important stand-alone description to inform the understanding of the magnitude of the problem and help guide implementation of measures to reduce the risk of nosocomial infection and multi-drug resistance.

NCT ID: NCT03358576 Completed - Clinical trials for Intra Abdominal Infections

Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)

Start date: September 18, 2018
Phase: Phase 3
Study type: Interventional

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin-metronidazole for treatment of complicated intra-abdominal infections in adults.

NCT ID: NCT03354598 Completed - Clinical trials for Uncomplicated Urinary Tract Infections

Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

Start date: August 1, 2018
Phase: Phase 3
Study type: Interventional

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women

NCT ID: NCT03353532 Completed - Clinical trials for Staphylococcus Aureus

Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

SALT
Start date: August 1, 2017
Phase:
Study type: Observational

This is a retrospective multinational, multicenter cohort study with a nested case-control. The study includes all surgical procedures performed at a participating site to prevent bias. Data will be assessed in two populations. Cohort population: Export of electronic file data on demographics, surgical procedure ICPM code, duration of procedure, American Society of Anesthesiologists (ASA) score, body mass index, comorbidity ICD codes, and wound class of all patients undergoing surgery. Nested case-control population: For patients establishing S. aureus SSI and 1:1 matched controls from the same center further data will be captured: Length of hospitalization, length of ICU stay and reason as well as attribution to SSI, survival at 30 and at 90 days, antibiotic treatments including duration, functional status at admission and at final discharge; necessity for surgical revision, and death attributed to SSI. If readmission is necessary, reason and attribution to SSI, length of hospitalization and length of ICU stay as well as all antibiotic treatments and their duration will be recorded. The cases causative pathogens including resistance patterns and type of SSI according to CDC criteria will be captured. Matching criteria comprise the following: - Type of procedure - Age - ASA score - BMI - Duration of procedure (as percentile for this procedure) - Diabetes - Sex

NCT ID: NCT03353506 Completed - Clinical trials for Recurrent Clostridium Difficile Infection

Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection

Start date: February 14, 2018
Phase: Phase 2
Study type: Interventional

Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry. Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).

NCT ID: NCT03353051 Completed - Neonatal Infection Clinical Trials

Iron and Infection: Neonatal Nutritional Immunity

NeoInnate
Start date: July 25, 2017
Phase:
Study type: Observational

The motivation for this study was produced from our preliminary data, which showed that during the first 96 hours of life a full-term neonate will actively reduce the overall serum iron concentration of their blood and the transferrin saturation decreases rapidly from 45% in cord blood to ~20% by six hours post-delivery. The Investigators hypothesise that this active sequestration of iron, which results in hypoferremia, is done in an effort to limit susceptibility to infection, a process referred to as nutritional immunity. Currently, little is known about iron regulation and iron homeostasis during the first week of life and even less is known about the comparisons of nutritional immunity between full term, preterm and low birth weight neonates. Additionally, limited research has been conducted on the impact of these processes on bacterial pathogens. In an effort to study the neonatal nutritional immunity and its role in neonatal susceptibility to infection, The investigator will conduct an observational study in full-term, preterm and low birth weight vaginally-delivered neonates born at Serrekunda General Hospital, The Gambia. The investigators will fully characterise and quantify nutritional immunity during the early neonatal period and the investogators will assess how this impacts bacterial growth. Study sensitisation will occur at the antenatal clinic, during the mother's second trimester of pregnancy. Mothers will be consented and enrolled at delivery. Blood samples will be collected once from the umbilical cord and at serial time points from the neonates over the first week of life.

NCT ID: NCT03349814 Completed - Appendicitis Clinical Trials

Explanations for Negative Laparoscopic Appendectomies and Normal Laparoscopies

Start date: November 21, 2017
Phase:
Study type: Observational

Trial The aim of the study is to investigate which infectious diseases might mimic the symptoms of acute appendicitis to a degree to cause a diagnostic laparoscopy or laparoscopic appendectomy. The primary outcome is to compare the incidence of Yersinia spp. infection in patients, who undergo surgery due to suspected appendicitis, between those with and without appendicitis detected by polymerase chain reaction on rectal swabs. The secondary outcomes are comparison of the incidence of bacterial pathogens (Campylobacter spp., Salmonella spp., Shigella spp., Aeromonas spp.) and Enterobius vermicularis in the two groups. Rectal swabs, appendix swabs, and blood samples are collected prospectively and research biobanks will be established. Initially, the rectal samples and serology samples will be investigated, and possible biomarkers and results of the appendix swabs will be evaluated at a later time point. Ethics The trial will be conducted according to the Helsinki II Declaration after approval from both the local Health Research Ethics Committee and the Danish Data Protection Agency. An informed written consent will be collected from the participants prior to inclusion in the study. Data will be stored according to the approval from the Danish Data Protection Agency. This study is conducted in patients with suspected appendicitis. These patients are fully awake and conscious at time of inclusion. The patients included in this study will not experience any adverse effects due to their participation.

NCT ID: NCT03346603 Completed - Clinical trials for Urinary Tract Infections

Prevalence of Antimicrobial-resistant Pathogens in Patients Admitted for UTIs

Start date: February 8, 2018
Phase:
Study type: Observational

Between 2013-2014, our study network of U.S. emergency departments, EMERGEncy ID NET, found that the rate of fluoroquinolone-resistant E. coli was 11.7% among all patients, 6.3% in uncomplicated and 19.9% in complicated. ESBL-producing Enterobacteriaceae were found in 7.7% of all cases, 2.6% in uncomplicated and 12.2% in complicated. More recently, Enterobactericeae and gram-negative non fermenting bacteria have started to show resistance to carbapenems (CREs and CR-NF). Patients hospitalized with UTI and urosepsis represent a higher risk population for infections due to multi-drug resistant bacteria and experience serious adverse outcomes, including death. EMERGEncy ID NET will conduct a study to determine the prevalence of ESBL-producing, CREs and CR-NFs among this high risk population of patients admitted for UTI from U.S. emergency departments.

NCT ID: NCT03345992 Completed - Sepsis Clinical Trials

Benefit of Clarithromycin in Patients With Severe Infections Through Modulation of the Immune System

INCLASS
Start date: December 15, 2017
Phase: Phase 3
Study type: Interventional

High mortality associated with sepsis and Multiple Organ Dysfunction Syndrome (MODS) calls for alternative, individualized therapies in selected patients that might benefit form specific interventions. Role of macrolides as potential immunomodulatory treatment in sepsis is promising, but unclear. Subgroup analysis of previous large-scale clinical trials on patients with ventilator-associated pneumonia or gram-negative sepsis, showed that addition of clarithromycin to standard antibiotic therapy conferred a significant survival benefit in the subgroup of patients with respiratory dysfunction and MODS. The INCLASS study is aiming to assess the efficacy of intravenous treatment of clarithromycin in the reduction of 28-day mortality among patients suffering from these entities.