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Communicable Diseases clinical trials

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NCT ID: NCT04420221 Active, not recruiting - Clinical trials for Infections, Soft Tissue

Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)

Start date: June 29, 2020
Phase: Phase 2
Study type: Interventional

Safety, immunogenicity and efficacy of GSK S. aureus candidate vaccine (GSK3878858A) when administered to healthy adults (dose-escalation) and to adults 18 to 64 years of age with a recent S. aureus skin and soft tissue infection (SSTI). In the dose-escalation safety lead-in phase in healthy adults safety and immunogenicity of 4 different compositions is assessed. After safety has been shown in this phase, in the second phase, proof of principle (PoP) phase of the study in adults with a recent SSTI safety, immunogenicity and efficacy of the final composition of the vaccine is assessed.

NCT ID: NCT04416373 Recruiting - Breastfeeding Clinical Trials

COVID-19 and Pregnancy Outcomes

COVID&PREG
Start date: March 22, 2020
Phase:
Study type: Observational

This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

NCT ID: NCT04415424 Active, not recruiting - Clinical trials for Neisseria Gonorrheae Infection

Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men

GoGoVax
Start date: July 8, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3, double-blinded, randomised placebo-controlled, multi-centred trial evaluating the efficacy of the four-component meningococcal B vaccine, 4CMenB (Bexsero®), in the prevention of Neisseria gonorrhoeae infection.The targeted population is 18-50 years-old men (cis and trans), trans women and non-binary people who have sex with men (hereafter referred to as Gay Bisexual Men+ [GBM+], either HIV-negative and taking pre-exposure prophylaxis [PrEP], or HIV-positive with undetectable viral load <200copies/ml and a cluster of differentiation 4 [CD4] count >350 cells/cmm) who have high N. gonorrhoeae incidence and are recommended by Australian guidelines to have regular, comprehensive sexual health screening. 730 participants will be enrolled and randomised 1:1 and stratified by clinical sites to receive two doses of 4CMenB vaccine or a matching placebo at 0 and 3 months by intramuscular injection. Recruitment is for 12 months and all participants will be follow-up 3-monthly for a period of 2 years. The trial aims to evaluate the efficacy of 4CMenB in the prevention of N. gonorrhoeae infection.

NCT ID: NCT04414631 Terminated - Clinical trials for Coronavirus Infections

Conestat Alfa in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19

Start date: August 6, 2020
Phase: Phase 2
Study type: Interventional

The aim of this study is to analyze if administration of conestat alfa for 72 hours in addition to standard of care (SOC) in patients hospitalized with non-critical SARS-CoV-2 pneumonia (WHO Ordinal Scale Score 3 or 4) reduces the risk of disease progression to Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).

NCT ID: NCT04413838 Not yet recruiting - Clinical trials for Obesity, COVID-19 Infection

Efficiency and Security of NIVOLUMAB Therapy in Obese Individuals With COVID-19(COrona VIrus Disease) Infection

NIVISCO
Start date: June 15, 2020
Phase: Phase 2
Study type: Interventional

Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus). Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19. In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production. This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15

NCT ID: NCT04413565 Recruiting - Clinical trials for Arthroplasty Complications

Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study

Start date: December 8, 2016
Phase: N/A
Study type: Interventional

The use of bilateral total knee replacements (TKR) is increasing with the number of patients with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral TKR); single-stage, a sequential bilateral TKR (single surgeon bilateral TKR); and two-stage bilateral TKR. Periprosthetic joint (PJI) infections are serious complications after TKR that negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity and mortality. The incidence of PJI is 1-2% and the number of cases is projected to grow as the indications for TKR continue to increase. Investigators will prospectively compare the incidence of periprosthetic joint infection between groups.

NCT ID: NCT04413305 Recruiting - Clinical trials for Klebsiella Pneumoniae Infection

WGS-guided Tracking and Infection Control Measures of CRKP

Start date: May 28, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to investigate the effect of the infection control measures based on the active screening of carbapenem-resistant Klebsiella pneumoniae and whole-genome based tracking and surveillance though the hospital.

NCT ID: NCT04412811 Completed - Clinical trials for Hematologic Diseases

Prospective Survey of CMV, Herpesviruses Infections and Diseases in Allo-HSCT

CYTOALLOSURVEY
Start date: January 1, 2021
Phase:
Study type: Observational

Prospective observational study of epidemiological surveillance, multicenter, non-profit, spontaneous, Italian with objective to describe the incidence of CMV infections and diseases in adult and pediatric patients undergoing allo-HSCT during the first 6 months from transplant. This study will evaluate approximately 1500 subjects (with competitive enrolment) from GITMO investigational centers.

NCT ID: NCT04412551 Completed - Clinical trials for Corona Virus Infection

Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19

Start date: May 20, 2020
Phase:
Study type: Observational [Patient Registry]

This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.

NCT ID: NCT04412395 Not yet recruiting - COVID-19 Clinical Trials

Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease

COVID-19_LF
Start date: February 1, 2022
Phase: Phase 2
Study type: Interventional

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.