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NCT ID: NCT05831189 Recruiting - Clinical trials for Clostridium Difficile Infection Recurrence

A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection

CDI-SCOPE
Start date: April 21, 2023
Phase: Phase 3
Study type: Interventional

This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy. More specifically, the purpose of this trial is to explore the safety and clinical effectiveness of RBX2660 when delivered by colonoscopy to adults with rCDI. The experience of physicians will be documented through a physician-experience questionnaire to explore the usability of RBX2660 in clinical practice for colonoscopic administration. Furthermore, to explore the patient-experience of RBX2660 treatment, each trial participant will be offered to undergo a structured interview.

NCT ID: NCT05830357 Recruiting - Clinical trials for Helicobacter Pylori Infection

Prevalence and Risk Factors of Helicobacter Pylori Infection in Children and Young Adults

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

Helicobacter pylori is a gram-negative bacterium that resides in the stomach and can cause inflammation leading to long-term effects, such as gastric ulcers, cancer, and lymphoma of the stomach mucosal linings Previous research and analysis of H. pylori prevalence in populations have examined common risk factors that increase the likelihood of acquiring the bacteria. Some of the most commonly identified risk factors across various studies in different geographic populations are larger family size, less education, lower socioeconomic status, less frequent hygiene practices, and lower sanitation with specific emphasis on sources of water and defecation. aim of the work: Studying prevalence of Helicobacter Pylori infection and its related risk factors in children and young adults in Sohag governorate.

NCT ID: NCT05830162 Recruiting - Infections Clinical Trials

Oral Antibiotics After Obstetric Perineal Tear

REPAIR
Start date: March 21, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate if 3 dose of oral antibiotics administrated the first day after a vaginal delivery with a second degree obstetric tear will decrease the risk of infection and/or wound dehiscence compared to women with 3 doses of placebo treatment.

NCT ID: NCT05828563 Not yet recruiting - Clinical trials for Pesticide Adverse Reaction

Immunological Indices and Infections Among Pesticide Applicators in Sohag Governorate

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The human body gets exposure to pesticides either directly or indirectly. By using pesticides on crops, humans come in direct contact with them and they affect the heaith Immune system is the first defense line against pathogenic organisms; however, it is altered by the vulnerable environmental factors such as pesticides, which can cause structural or functional alterations in humoral or cell mechanisms (nonspecific or adaptive) of the immune response which lead to an increase in the susceptibility to infections

NCT ID: NCT05826873 Enrolling by invitation - Clinical trials for Urinary Tract Infections

Discharge Stewardship in Children's Hospitals

DISCO
Start date: June 10, 2020
Phase: N/A
Study type: Interventional

The goal of this interventional study is to test if a discharge stewardship bundle is effective at reducing inappropriate antibiotic prescriptions at hospital discharge for children with the three common infections: community-acquired pneumonia (CAP), urinary tract infections (UTI), and skin/soft tissue infections (SSTI). The goals of this study are: - To develop, locally adapt, and implement a discharge stewardship intervention across four geographically diverse children's hospitals. - To measure the impact of the discharge stewardship intervention on antibiotic prescribing and patient outcome for three common pediatric infections. Families who are enrolled in the study will be asked to: - complete a one question wellness track on days 3, 7, and 21 after hospital discharge - complete a brief survey on days 7 and 21 after hospital discharge The study team will conduct interviews with the hospitalists at each of the four participating hospitals to create a "discharge stewardship" bundle. Once the bundle intervention is implemented, the hospitalists will be asked to follow prescribing guidelines for CAP, UTI, and SSTI. They will receive regular group-level feedback reports to show how well they follow the guidelines and motivate the hospitalists to follow the guidelines better.

NCT ID: NCT05826067 Not yet recruiting - Clinical trials for Urinary Tract Infections

Study of E. Coli Isolates From Recurrent Urinary Tract Infections

Per-UTI
Start date: April 20, 2023
Phase:
Study type: Observational

Prospective study aiming at collecting clinical Escherichia coli isolates from patients with recurrent urinary tract infection; samples to be collected during routine procedures.

NCT ID: NCT05824988 Recruiting - Clinical trials for Gram-Positive Bacterial Infections

Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease

Start date: April 14, 2023
Phase:
Study type: Observational

The incidence and prevalence of nontuberculous mycobacteria (NTM) infections have gradually increased over the years worldwide (1-3). In China, Mycobacterium avium complex (MAC) was the most prevalent NTM specie (4), while challenged by long treatment duration, frequent drug-induced adverse events, lack of treatment alternatives, poor treatment outcome and high recurrence rate (5, 6). In order to maximize the efficacy of the few available drugs and prevent the development of drug resistance, ensuring adequate plasma drug concentrations are of importance. Despite the role of pathogen susceptibility, determined by minimum inhibitory concentration (MIC), is non-negligible, the evidences regarding its association with treatment outcome are limited, especially for rifamycin and ethambutol. The difficulties in explaining the clinical values of MIC might partially be attributed to the lack of in vivo drug exposure data, which cannot be accurately predicted by the dose administered because of between-patient pharmacokinetic variability (7). Therapeutic drug monitoring (TDM) is a strategy to guide and personalize treatment by measuring plasma drug concentrations and pathogen susceptibility, which might have the potential to improve treatment response to MAC lung disease. In this observational study, the hypothesis is that the drug exposure and/or MIC of antimycobacterial drugs are correlated to the treatment response of MAC lung disease, which is assessed from the perspective of treatment outcome, mycobacterial culture negative conversion, lung function, radiological presentation and self-reported quality of life. Consenting adult patients with culture-positive MAC lung disease will be recruited in study hospital. Respiratory samples (sputum and/or bronchoalveolar lavage fluid) will be collected regularly for mycobacterial culture on the basis of BACTEC MGIT 960 system and MIC will be determined using a commercial broth microdilution plate. Drug concentrations will be measured at 1 and/or 6 months after treatment initiation using liquid chromatography tandem mass spectrometry (LC-MS/MS). The final treatment outcome is recorded at the end of MAC treatment and defined according to an NTM-NET consensus statement (8).

NCT ID: NCT05821946 Recruiting - Clinical trials for Kidney Transplantation

Web-Based Multi-Resource Training on the Prevention of Urinary Tract Infections in Adult Kidney Transplant Recipients

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Purpose: The study aims to examine the effect of web-based multi-source training on the prevention of urinary tract infections in adult kidney transplant recipients on clinical outcomes. Design: The study is a single-center, parallel-group, single-blind, pretest, and posttest randomized controlled experimental study. Methods: A total of 90 kidney transplant recipients, 45 in the control group and 45 in the intervention group will be included in the study. Kidney transplant recipients will be randomized on the day of discharge. Before discharge, the Patient Socio-Demographical/Descriptive Characteristics Form and the Discharge Readiness Scale will be applied to the control and intervention groups. Routine training and aimed at preventing urinary tract infections web-based multi-source training will be provided to the intervention group. The developed educational material was evaluated by experts in terms of literacy, reliability, and information quality. As multiple resources on the web: there will be written and visual texts of the educational material, as well as podcasts and animation videos. Web page usability will be evaluated with the System Usability Scale. Individuals will be able to benefit from each of these multiple educational resources according to their preferences. The control group will be directed to the organ transplantation handbook on the website of the routine education and organ transplant center. After discharge, the follow-ups of the intervention and control group were carried out during the first 6-month post-transplant standard follow-up process of the center (2. day; once a week for the first month; every ten days for up to 1-3 months; every three weeks for the next 3-6 months) will be performed. When patients come to their controls, the results of routine examinations (complete urinalysis, urine culture taken when necessary, hospitalization, emergency application, and other data) will be taken from the Hospital Information Management System. In addition, the recipients' opinions in the intervention group on the Web-Based Multi-Resource Training Program will also be received at the end of the 6th month. The research adhered to the Standard Protocol Items: Recommendations for Interventional Trials-SPIRIT (2013) and Consolidated Standards of Reporting Trials-CONSORT (2018) checklists.

NCT ID: NCT05820594 Recruiting - Tuberculosis Clinical Trials

Using BCG Vaccine to Understand Tuberculosis Infection

Pilot BCG CHIM
Start date: June 30, 2023
Phase: N/A
Study type: Interventional

Tuberculosis (TB) is a disease that usually causes an infection in the lungs. The only vaccine to prevent TB is called BCG (Bacillus Calmette-Guérin). BCG contains a live germ similar to Mycobacterium tuberculosis, the germ that causes TB. BCG does not work very well, and TB remains the most common cause of death by infection worldwide. Human challenge models involve exposing healthy volunteers to an infectious disease in a safe and controlled way. This helps researchers understand more about an infectious disease and the body's response and can help develop new vaccines and treatments. The purpose of this study is to set up a human challenge model using BCG to understand how the body responds to this. If our human challenge model works well it may be used to help researchers develop new vaccines and tablets to treat TB in the future. This study will recruit healthy volunteers, of all genders, age 18-50 years. The first part of the study (phase A) will recruit 10 participants. Participants in phase A will receive intradermal injection with BCG into the upper arm at three times the usual dose. On day 14 after BCG the following skin samples will be taken from the BCG site with the use of local anaesthetic: skin swab, microbiopsy, skin scrape and punch biopsy. Participants in this phase of the study will also have blood tests to ensure they are safe to take part and to monitor the immune response to BCG. The overall aim of this part of the study will be to ensure BCG can be isolated (grown in culture and by molecular techniques) from participants' BCG site 14 days after the injection. The investigators aim to test whether BCG can be isolated by punch biopsy and minimally invasive techniques (microbiopsy, skin scrape and skin swab). If the investigators find that they can isolate BCG successfully using the minimally invasive methods of skin sampling and the participants have not experienced any serious adverse events, they can proceed to phase B of the study. In phase B 20 participants will be recruited. These participants will receive BCG as described for phase A. They will then have serial skin samples taken using either microbiopsy, skin scrape or skin swab on days 0, 2, 7, 14 and 28. The focus of this phase of the study is to assess immune responses to intradermal injection at the local (skin), systemic (blood) and respiratory mucosal (nose) compartments. This will involve longitudinal sampling from blood, nose and skin to measure BCG growth and the immune response over time.

NCT ID: NCT05819229 Recruiting - Clinical trials for Urinary Tract Infections in Children

Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection

Start date: February 27, 2023
Phase:
Study type: Observational

The goal of this prospective study is to investigate whether oral antibiotic therapy alone is feasible and safe in clinically stable children aged 4 weeks to 2 months without any past high-risk medical history with a suspected or confirmed urinary tract infection.