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NCT ID: NCT04807894 Recruiting - Vaginal Atrophy Clinical Trials

Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

PIVoT
Start date: November 1, 2020
Phase: Phase 4
Study type: Interventional

Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora associated with menopause. After menopause, there is a chemical changes in the vagina that may predispose to bacterial infections. The role of vaginal estrogen creams to restore vaginal atrophy and prevent urinary tract infections has been well characterized. Vaginal testosterone (VT) application use in postmenopausal breast cancer patients on aromatase inhibitors have been shown to improve vaginal pH, vaginal atrophy symptom scores, dyspareunia, and vaginal dryness. Although testosterone has been used to improve sexual function in postmenopausal women, the effects of VT on vaginal flora and recurrent UTIs are unknown. The purpose of this study is to determine whether topically applied vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections and to ascertain the effects of topical estrogen on the vaginal pH and flora.

NCT ID: NCT04801862 Recruiting - Clinical trials for Clostridium Difficile Infection

Natural History of Clostridioides Difficile Infection

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Aim: To investigate if host factors, such as composition and diversity of intestinal microbiota and/or genetic determinants, are associated with a higher risk of recurrence of Clostridioides difficile infection (CDI). To generate a predictive tool based on epidemiological, clinical, genetic and microbiologic variables aimed to identify patients at a higher risk of CDI recurrence in a context of optimized ICD management. Design: Multicenter prospective cohort study. Patients: Older than 18 years patients with CDI diagnosis, made by IDSA criteria, in the participant centers. Follow-up: A stewarship program aimed to improve CDI management, including early detection of CDI recurrence, will be implemented in the participant centers. Blood samples for genetic testing and stool samples for intestinal microbiome studies will be collected. Variables and data analysis: The primary outcome variable will be the emergence of CDI recurrence. Potential independent predictors of recurrence, including genetic and microbiological factors, will be assessed. A predictive tool based on independent predictors of recurrence will be built in a development subpopulation. The performance of the model will be assessed by ROC curves, and sensititvity, especificity, as well as negative and positive predictive values will be calculated, both in the development subpopulation and in a validation subset.

NCT ID: NCT04801615 Recruiting - Clinical trials for Necrotizing Soft Tissue Infection

Characteristics of Patients With Necrotizing Soft Tissue Infections

Start date: September 1, 2020
Phase:
Study type: Observational [Patient Registry]

To study the demographic characteristic of patients with necrotizing soft tissue infections.

NCT ID: NCT04799808 Recruiting - Clinical trials for SARS-CoV-2 Infection

Saxon SARS-CoV-2 Infection and Vaccination Study in Dialysis Patients, Solid Organ Recipients and Staff

DIA-Vacc
Start date: January 15, 2021
Phase:
Study type: Observational

To investigate short- (3 and 8 weeks) and long-term (6, 9, 12, and 18 months) immune protection or response at the humoral and cellular levels before and after SARS-CoV-2 infection or vaccination in patients with moderately reduced immune status (dialysis patients) and severely reduced immune status (organ transplant recipients, mostly kidney transplant recipients) and immunocompetent subjects (medical staff) in Saxony, Germany.

NCT ID: NCT04793152 Recruiting - MRSA Clinical Trials

Vancomycin Dosing for Serious MRSA Infections: A Non-inferiority Randomized Trial of Trough Level Versus AUC/MIC

Start date: March 20, 2023
Phase: N/A
Study type: Interventional

Intravenous vancomycin is considered first line therapy for serious methicillin-resistant Staphylococcus aureus (MRSA) infections including bacteremia, central nervous system infection, pneumonia, pleural space infection, bone or joint infection, prosthetic joint infection and deep abscesses. The effectiveness and toxicity of vancomycin depend on its dosing and chosen target. The most recent guidelines suggest targeting area under the curve over 24 hours over minimum inhibitory concentration (AUC/MIC) of 400 to 600. Implementation of AUC/MIC requires Bayesian software that can be variable, costly, complicated and time consuming. Ideally, AUC/MIC dosing would also require susceptibility testing by broth microdilution, which is not commonly done. It is recommended to target AUC of 400 to 600 assuming a MIC of 1ug/mL when MIC by broth microdilution is not known. Targeting a trough level of 10 to 15mg/L may be a reasonable and more practical alternative without compromising effectiveness. We will be conducting a randomized controlled non-inferiority trial to compare intravenous vancomycin dosing strategy targeting a trough level of 10 to 15mg/L versus AUC of 400 to 600 assuming a MIC of 1ug/mL by broth microdilution for serious MRSA infections. The primary outcome will be treatment failure, which is a composite of mortality and microbiologic failure at 90 days. We hypothesize that targeting a trough level of 10 to 15mg/L is non-inferior to targeting a AUC of 400 to 600 in terms of treatment failure. The criterion for non-inferiority is that a two-sided 95% confidence interval for difference in risk of treatment failure will lie within the non-inferiority margin of 10%.

NCT ID: NCT04787575 Recruiting - Infection Clinical Trials

Oxygen-ozone Therapy Plus Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices

Start date: January 24, 2024
Phase: N/A
Study type: Interventional

This is an open-label, multicentre, randomized, parallel group study to evaluate the efficacy of treatment with oxygen-ozone therapy plus oral antibiotic therapy, in comparison with oral antibiotic therapy alone, in the proportion of patients with resolution/improvement of signs and symptoms of infection of the wound (e.g. ulcer, eschar, sore) in the target lesion after 14 days of treatment, in patients with infections secondary to implant of orthopaedic devices.

NCT ID: NCT04782674 Recruiting - EBV Infection Clinical Trials

Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases

Start date: March 15, 2021
Phase:
Study type: Observational

This study is a single-center, prospective, observational clinical study to evaluate the Application of saliva EBV-DNA Detection in EBV Infection Related Diseases

NCT ID: NCT04773457 Recruiting - Clinical trials for Surgical Site Infection

Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients

Start date: April 1, 2023
Phase:
Study type: Observational

Surgical site infections (SSIs) are one of the major hospital acquired infections and responsible for the most cost among the hospital acquired infections. The objective of this study is to assess the neutrophil functional profiles and their associations with SSIs.

NCT ID: NCT04762706 Recruiting - Clinical trials for Prosthetic Joint Infection

Measuring Distress in Prosthetic Joint Infection Using a Standardized Metric: CRUTCH Pathway Pilot.

Start date: March 4, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether patients being treated for prosthetic joint infections (PJI) experience distress during the course of their treatment and how distress influences various aspects of their lives. WVU expects to enroll approximately 12 subjects. Patients identified as scoring ≥4 on the Distress Thermometer at the two-week follow-up visit will be offered the opportunity to participate in the novel CRUTCH Pathway. Once enrolled, you will meet virtually with a mental health provider. The mental health provider will complete a 30-minute intake visit where he will review your distress thermometer scoring, discuss contributing factors to current distress level, and assess for psychiatric comorbidities.

NCT ID: NCT04761107 Recruiting - COVID-19 Infection Clinical Trials

Impact of COVID-19 on GU Disease

Start date: February 18, 2021
Phase:
Study type: Observational

The purpose of this research study is to identify patients with GU disease with active or past COVID-19 infection. Participants will be asked to: - Complete an Online COVID-19 Questionnaire. - Disclose if the patient has or had Genitourinary cancer or benign urologic condition - Provide urine specimen for research - Provide 4 tablespoons of blood for testing blood for research. - Provide permission to access medical records, such as patient lab results, medical history, imaging reports, etc.