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NCT ID: NCT05060419 Not yet recruiting - Clinical trials for Acute Pyelonephritis

Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections

Start date: October 8, 2021
Phase: Phase 2
Study type: Interventional

Phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis.Treatment duration for each cohort was 7 to 14 days. Patients were not permitted to switch to oral therapy.

NCT ID: NCT05050786 Not yet recruiting - Quality of Life Clinical Trials

Prophylactic Negative Pressure Wound Therapy for Patients Undergoing Incisional Hernia Repair

PROPRESS
Start date: January 2022
Phase: N/A
Study type: Interventional

The study will examine the effect of using Negative Pressure Wound Therapy (NPWT) compared with standard wound dressing among patients undergoing elective open surgery for incisional hernia. The study's main hypothesis is that NPWT will decrease the post-operative incidence of surgical site infections and also improve the patients' quality of life including less scar-related pain and higher cosmetic satisfaction.

NCT ID: NCT05047666 Not yet recruiting - Clinical trials for COVID-19 Respiratory Infection

COVID-Like Illness Respiratory Pathogens. A Prospective Cohort on the COVID-19 Post-acute Condition

CLEAR
Start date: October 2021
Phase:
Study type: Observational

Identifying multiorgan sequalae and complications through high quality, prospective matched controlled studies throughout the course of COVID-19 is important for the acute and long-term management of patients and for health systems' planning. Further, it is key to understand the link between acute illness and long term consequences particularly in those already living with other comorbidities such as cardiovascular diseases or cancer. Since the clinical presentation of COVID-19 can resemble a variety of common respiratory infections, describing the distribution of pathogens and the severity of clinical presentation associated with COVID-like illnesses (CLI) infections is important to generate a baseline clinical description by comparing potential long-term effects of PCR-confirmed COVID-19 to those following other respiratory infections. To gain a better understanding of the clinical burden on COVID-19 survivors we will undertake a comparative evaluation within a cohort of PCR-confirmed individuals with COVID-19 vs. those PCR-confirmed symptomatic individuals with other respiratory pathogens plus healthy individuals from the community. The results will inform strategies to prevent long term consequences; inform clinical management, interventional research, direct rehabilitation, and inform public health management to reduce overall morbidity and improve outcomes of COVID-19.

NCT ID: NCT04993027 Not yet recruiting - Clinical trials for Infection of Total Knee Joint Prosthesis

Topical Vancomycin for Infection Prophylaxis in TJA

Start date: June 30, 2024
Phase: Phase 2
Study type: Interventional

11% of the general population undergo total hip arthroplasty (THA) in their lifetime and 7% undergo total knee arthroplasty (TKA), with these rates expected to rise up to 50% by 2026. Periprosthetic joint infection (PJI) remains one of the most common complications, accounting for 30% of THA/TKA revision surgeries. Topical delivery of antibiotic powder may reduce the incidence of PJI but its potential drawbacks include wound healing complications, reduced osteoblast activity, third body wear, and antibiotic resistance. In THA and TKA, topical administration of vancomycin powder for the primary prevention of PJI has been studied in observational studies, but conclusions are limited due to the low incidence of PJI and high number of patients required to detect a significant difference. Investigators therefore propose a randomized controlled trial (RCT) investigating the impact of topical vancomycin compared to standard care on PJI rates following THA and TKA. Aim: To determine whether topical vancomycin is a safe and effective intervention for the primary prevention of PJI after THA and TKA. Study Design: This is a pilot multi-centre RCT to evaluate the study design and assess feasibility prior to implementation across Canada. Investigators aim to recruit 50 THA and 50 TKA patients. Inclusion Criteria THA or TKA Patients aged 18 years or older Patients must complete 1 year follow-up Exclusion Criteria Patients undergoing surgery for inflammatory arthritis, post-traumatic arthritis, or avascular necrosis History or septic arthritis based on history or synovial aspirate Prior major operation on the affected joint Current immunosuppressive medications Vancomycin allergy or history of a vancomycin-related complication Recruitment: surgeons introduce study to the patients, research staff will conduct recruitment. Intervention: Patients will be randomized preoperatively and remain blinded to their treatment arm. Patients allocated to the control group will have all standard care infection prophylaxis interventions. Patients allocated to the vancomycin group will undergo all the standard care measures in addition to 1g of powdered vancomycin applied to the wound. Follow-up: Patients will complete follow-up at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year visits. Primary outcome: PJI in the same joint. Secondary outcome: PJI in THA and TKA subgroups: Reoperation on the same joint Superficial and non-infectious wound complications All complications

NCT ID: NCT04978038 Not yet recruiting - Clinical trials for Coronavirus Infection

Fourth Dose of mRNA COVID-19 Vaccine in Residents of LTCFs

Start date: August 1, 2022
Phase: Phase 4
Study type: Interventional

This study is a multi-centre, blinded, randomized controlled trial. LTCF residents ≥ 65 years who have received three doses of mRNA vaccine will be randomized to vaccination with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine or to vaccination with a control (Prevnar-13 vaccine).

NCT ID: NCT04960306 Not yet recruiting - Clinical trials for Clostridium Difficile Infection

Fecal Filtrate as a Treatment Option of Multiple Recurrent Clostridioides Difficile Infection

FILTRATE
Start date: November 1, 2023
Phase: Phase 3
Study type: Interventional

Clostridioides difficile infection (CDI) is one of the most common hospital-acquired infectious diseases with a high mortality rate (6-30%). The treatment of CDI, especially the recurrent form of the disease is still considered a challenge. The FILTRATE randomized controlled trial aims to investigate the safety and efficacy of fecal filtrate transplantation in the treatment of recurrent CDI and compare it with conventional fecal microbiota transplantation (FMT).

NCT ID: NCT04955210 Not yet recruiting - Critical Illness Clinical Trials

A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children

Start date: May 30, 2024
Phase:
Study type: Observational

1. To research the current situation of severe infection in children in China, and to investigate the incidence, prognosis and disease burden of severe infection in children in different regions of China. 2. Establish the risk prediction model and diagnosi model of severe infection in children, and verify the accuracy of the model in multi-center; 3. To study the effectiveness and safety of different treatments in real diagnosis and treatment, and to evaluate the efficacy of subgroups under different ages and high risk factors.

NCT ID: NCT04851015 Not yet recruiting - Clinical trials for Pneumocystis Pneumonia

Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia

LOW-TMP
Start date: June 2022
Phase: Phase 3
Study type: Interventional

Pneumocystis jirovecii pneumonia (PJP) is an opportunistic fungal infection of immunocompromised hosts which causes in significant morbidity and mortality. The current standard of care, trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg/kg/day of TMP, is associated with serious adverse events, including hypersensitivity reactions, drug-induced liver injury, cytopenia, and renal failure occurring among 20-60% of patients. The frequency of adverse events increases in a dose dependent manner and commonly limits the use of TMP-SMX. Reduced treatment doses of TMP-SMX for PJP reduced ADEs without mortality differences in a recent meta-analysis of observational studies. We therefore propose a Phase III randomized, placebo-controlled trial to directly compare the efficacy and safety of low dose (10 mg/kg/day of TMP) compared to the standard-of-care (15 mg/kg/day) among patients with PJP for the primary outcome of death, new mechanical ventilation, and change of treatment.

NCT ID: NCT04803435 Not yet recruiting - Clinical trials for Gastrointestinal Infection

Telemedicine and Face-to-face Consultations Diagnostic Accuracy Comparison in Gastrointestinal Infection Patients

Start date: February 20, 2022
Phase: N/A
Study type: Interventional

Acute gastroenterocolitis (GECA) in healthy adults is a frequent cause of looking for medical care in emergency care units and most cases are aimed at etiology viral infection or food toxin, being generally self-limited with good prognosis and only need for treatment with behavioral measures and use of medications for relief symptomatic. Anamnesis is the main resource for the diagnosis and stratification of GECA severity and is infrequent alterations of physical examination and complementary examinations without association with symptoms of alert. Telemedicine has become a resource that allows easier and faster access to medical evaluation, with low cost and rational use of resources. Virtual emergency care is part of Hospital Israelita Albert Einstein (HIAE) institutional routine and there is a large number of consultations whose final diagnosis was GECA. It is not known whether the accuracy of diagnosis of GECA by telemedicine is not inferior to the diagnosis by face-to-face evaluation, considered the Golden pattern. The aim of the study is compare the diagnostic accuracy of GECA by telemedicine with that of face-to-face care. It is a prospective randomized study with a population of adult patients who sought in person the screening of the Morumbi Emergency Care Unit of HIAE with symptoms suggestive of GECA (diarrhea with or without other symptoms of the digestive tract and infectious). Patients whose screening will be excluded of nursing directed for immediate evaluation in the emergency room and patients with dysfunctions organisms or immunosuppression. Patients who accept and sign the informed consent form will be randomized into 2 groups: A) immediate face-to-face evaluation; B) evaluation initially by telemedicine and sequentially at face-to-face evaluation. In both cases, the ICD diagnostics will be compiled and grouped according to clinical significance and will be the primary outcome of the study. Service time, exams requested, guidelines, prescription and destination will also be analyzed. Patients and doctors who undergoing group B assessment will be blinded to the telemedicine assessment data.

NCT ID: NCT04703335 Not yet recruiting - Infectious Disease Clinical Trials

Pilot Clinical Trial - Comparative Study of Two Material Concentration of OD-141309

Odysseus-01
Start date: June 1, 2023
Phase: Early Phase 1
Study type: Interventional

A sufficient number of subjects will be entered into testing to complete 42 subjects per each of the 2 test and 2 control configurations. A total of 84 subjects, testing bi-laterally (168 abdomen and groin sites in total completed, 42 abdomen and groin sites per each test and control material) will be evaluated using the standardized ASTM E1173 test method. Following a 14-day restriction period, subjects will be sampled for baseline, 10 minutes, 6 hours, and 24 hours post application (subjects will not be sequestered) for microbial reduction evaluations. Test day baseline criteria will be set at: abdomen: ≥ 3.0 log10 CFU/cm2, and groin: ≥ 5.0 log10 CFU/cm2.