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NCT ID: NCT04333602 Completed - Clinical trials for Kidney Transplant Infection

Asymptomatic Bacteriuria in Early Kidney Transplantation Follow up

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Urinary tract infection (UTI) continues to be the leading cause of infection and hospitalization in post-kidney transplant (RT) surveillance. Facts such as immunosuppression, anatomical alterations and catheters are part of the factors that contribute to a high prevalence of this condition. The incidence during the first trimester is highly variable and ranges between 15 and 50 %. This variability often depends on the definition of UTI, which sometimes overlaps with asymptomatic bacteriuria (AB). Currently the indication for treatment of AB is clear in pregnant patients and urological procedures. In post-RT surveillance, the treatment of AB is controversial. The use of Trimetropim Sulfamethoxazole during the first 6 months post RT is currently a recommendation, however new evidence has found the absence of benefit in the treatment of AB. Given the high prevalence of post RT AB and the increase in bacterial resistance, determining the usefulness of searching for and treating post RT AB is a priority in this population. Methodology: Randomized Controlled trial of kidney transplant candidates which will be randomized in the following groups: Group 1 (intervention) where the urine cultures will be analyzed openly, and in the case of asymptomatic bacteriuria, treatment based on the germ and antibiogram will be prescribed. Group 2 will undergo urine cultures at the same post-transplant times, the results will not be known by the clinical team and the participants will not receive treatment in the presence of present AB. Both groups, in the presence of UTI symptoms, will undergo urine culture and receive empirical treatment, which will be adjusted based on an antibiogram. The primary objective is to assess the prevalence of UTI, pyelonephritis, UTI-related hospitalizations, and antimicrobial resistance. As a secondary objective, the germs and associated virulence genes will be analyzed. Surveillance will be carried out for two months after transplantation and the predefined times for the evaluation of the BA will be: after the removal of the urinary catheter, week 3 and after the removal of the ureteral stent (month 2).

NCT ID: NCT04333420 Completed - Clinical trials for Severe COVID-19 Pneumonia

Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

PANAMO
Start date: March 31, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Phase II & Phase III: This is a pragmatic, adaptive, randomized, multicenter phase II/III study evaluating IFX-1 for the treatment of COVID-19 related severe pneumonia. The study consists of two parts: Phase II, an open-label, randomized, 2-arm phase evaluating best supportive care (BSC) + IFX-1 (Arm A) and BSC alone (Arm B); and Phase III, a double-blind, placebo-controlled, randomized phase comparing standard of care (SOC) + IFX-1 (Arm A) versus SOC + placebo-to-match (Arm B)

NCT ID: NCT04333355 Terminated - COVID-19 Clinical Trials

Safety in Convalescent Plasma Transfusion to COVID-19

Start date: May 8, 2020
Phase: Phase 1
Study type: Interventional

There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. This plasma will be infused in patients affected by the same virus, but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. The investigator will evaluate the safety of this procedure by accounting for any adverse event.

NCT ID: NCT04333147 Terminated - Clinical trials for Arthritis, Rheumatoid

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

contRAst X
Start date: May 12, 2020
Phase: Phase 3
Study type: Interventional

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

NCT ID: NCT04332952 Completed - Clinical trials for Cardio-Renal Syndrome

Damage and Renal Clearance of Glycocalyx in Cardiac Surgery

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

The glycocalyx is a component of the vascular endothelium that currently plays a relevant role in the modified Starling theory. The manipulation of the heart during cardiac surgery stimulates the release of the natriuretic atrial peptide, which causes endothelial wear in patients undergoing extracorporeal circulation. Dilation of the atrium produces natriuretic atrial peptide, which reduces plasma volume by increasing renal excretion and vascular permeability. The atrial peptide degrades the surface of the coronary endothelium, causing loss of the side cam protein nucleus. This study investigates the relationship between clamping time in cardiac surgery and the clearance of endothelial inflammation markers.

NCT ID: NCT04327024 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction (HFpEF)

Study of Verinurad in Heart Failure With Preserved Ejection Fraction

AMETHYST
Start date: May 19, 2020
Phase: Phase 2
Study type: Interventional

International, Multicenter, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad combined with Allopurinol in Heart Failure with Preserved Ejection Fraction

NCT ID: NCT04326517 Recruiting - Clinical trials for Emphysematous Pyelonephritis

Factors Associated To Intensive Care Admission And Mortality In Patients With Emphysematous Pyelonephritis

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

Emphysematous pyelonephritis is a lifethreatening necrotizing infection of the kidney characterized by accumulation of gas in the renal parenchyma and within the surrounding tissues. The aim of the study is to report the outcome of the management of this condition at the investigators institution and to determine the microbiological characteristics, antibiotic resistance patterns, and to analyze factors predicting mortality and intensive care unit admission.

NCT ID: NCT04321850 Terminated - Oral Mucositis Clinical Trials

Impact of the Use of Zinc in the Prevention of Oral Mucositis in Pediatric Patients With Lymphoblastic Acute Leukemia.

Start date: June 10, 2019
Phase: N/A
Study type: Interventional

Oral mucositis (OM) is a secondary complication of chemo/radiotherapy, which causes pain, dysphagia and predisposition to infections, being a frequent reason for hospitalization that may have an impact on the prognosis of cancer patients. Various interventions for the prevention of OM have been studied, including the use of zinc, which is a micronutrient that participates in various cellular functions and in wound repair, while showing a reduction in the incidence and severity of MO, so the purpose of the present study is to evaluate the impact of the use of zinc in the prevention of oropharyngeal mucositis in pediatric patients with acute lymphoblastic leukemia in chemotherapy, comparing it with the use of placebo. Hypothesis: The use of zinc reduces the incidence and severity of OM in pediatric patients with ALL in chemotherapy compared to the control group.

NCT ID: NCT04320472 Active, not recruiting - COVID-19 Clinical Trials

Acute Encephalopathy in Critically Ill Patients With COVID-19

NeuroCOVID19
Start date: March 23, 2020
Phase:
Study type: Observational [Patient Registry]

Infection with SARS-CoV-2 or severe acute respiratory syndrome coronarvirus type 2 was highlighted in December 2019 in the city of Wuhan in China, responsible for an pandemic evolution since March 11, 2020. The infection affects all ages of life, although affecting children in a very small proportion of cases. The typical presentation of the disease combines fever (98%), cough (76%), myalgia and asthenia (18%) as well as leukopenia (25%) and lymphopenia (63%). Upper airway involvement rare. The main clinical presentation requiring hospitalization of infected patients is that of atypical pneumonia which may require critical care management (27%), and progress to an acute respiratory distress syndrome (67%) involving life-threatening conditions in almost 25% of patients diagnosed with SARS-CoV-2 infection. Other organ damage have been reported, mainly concerning kidney damage (29%) which may require renal replacement therapy in approximately 17% of patients. Neurological damage has been very rarely studied, yet reported in 36% of cases in a study including patients of varying severity. Finally, the mortality associated with this emerging virus is high in patients for whom critical care management is necessary, reported in 62% of patients. We therefore propose a prospective observational study which aim at reporting the prevalence of acute encephalopathy at initial management in Critical/Intensive care or Neurocritical care , to report its morbidity and mortality and to identify prognostic factors.

NCT ID: NCT04320342 Recruiting - COPD Clinical Trials

A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD

TRITON
Start date: April 28, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.