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Infections clinical trials

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NCT ID: NCT05699174 Recruiting - Amputation Clinical Trials

PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation

POvIV2
Start date: May 30, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.

NCT ID: NCT05695196 Recruiting - Clinical trials for Microbial Colonization

Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant

ParentsTREAT
Start date: October 25, 2023
Phase: Phase 1
Study type: Interventional

This feasibility and safety pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the participant's infant(s) will create a healthy, diverse neonatal nasal microbiome.

NCT ID: NCT05688592 Recruiting - Clinical trials for Invasive Fungal Infections

Usefulness of PET-CT for Invasive Fungal Infection

PETIFI
Start date: April 27, 2023
Phase:
Study type: Observational

The goal of this national multicenter prospective cohort study is to learn about the added value of 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose) PET-CT in invasive fungal disease management. The main questions it aims to answer are: 1. Does the use of 18F-FDG PET-CT allow a better characterization of invasive fungal infection (IFI) (performance) compared to the exclusive use of conventional radiological studies in terms of extension/staging and monitoring of response/follow-up ? 2. Does the systematic and protocolized use of 18F-FDG PET-CT in IFI allow a better management of patients with IFI and increase the prognostic value of the initial evaluation? Participants will undergo systematically a 18F-FDG PET-CT as part of the work-up of their invasive fungal disease. Researchers will compare the performance of 18F-FDG PET-CT with standard management without 18F-FDG PET-CT to see if adds value (diagnostic, prognostic, and changes in management).

NCT ID: NCT05688423 Recruiting - Clinical trials for Substance Use Disorders

Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients

CTN0121
Start date: January 5, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effectiveness of an integrated infectious disease/substance use disorder (SUD) clinical team intervention approach in patients hospitalized with severe injection-related infections (SIRI) who use drugs. The main question this study aims to answer is whether this intervention approach will be associated with lower mortality and fewer hospital readmissions. Participants will participate in the integrated SUD/ID care team intervention (SIRI Team). Researchers will compare this intervention to treatment as usual (TUA) to see if there are any differences in health outcomes.

NCT ID: NCT05687877 Recruiting - Clinical trials for SARS-CoV-2 Infection

Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS)

Start date: January 6, 2023
Phase:
Study type: Observational

To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.

NCT ID: NCT05685992 Recruiting - COVID-19 Infection Clinical Trials

Novel Coronavirus Infection and Reproductive Function

Start date: January 20, 2023
Phase:
Study type: Observational [Patient Registry]

This study aims to observe the impact of COVID-19 infection on the reproductive function and assisted pregnancy outcome of infertile couples undergoing assisted reproductive technology and to determine which factors are related to the clinical pregnancy rate. A multicenter, prospective, observational cohort study was adopted. Infertile couples who met the selection criteria were included in this study, the SAS anxiety self-rating scale was filled out, the basic situation was observed, and blood samples and related tissues were collected for testing. Relevant reproductive function, laboratory, clinical, and psychological indicators were collected, and the correlation between the above indicators and the outcome of the ART-related pregnancy were analyzed.

NCT ID: NCT05684549 Recruiting - Surgery Clinical Trials

Coronavirus Infection (COVID-19) and Radical Surgery in Patients With Early-stage Lung Cancer

COVIDLungSurg
Start date: January 11, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the effects of coronavirus infection in patients with early-stage lung cancer. The main question it aims to answer is whether the interval of surgery and COVID-19 infection will affect the surgery and prognosis of the patients.

NCT ID: NCT05684198 Recruiting - Clinical trials for Surgical Site Infection

NPWT vs Primary Closure in SSI Prevention for Emergency Laparotomies for Peritonitis

PRISTINE
Start date: January 11, 2023
Phase: N/A
Study type: Interventional

The study aims to evaluate the efficacy of negative pressure wound therapy (NPWT) compared with primary closure (PC) in surgical site infection (SSI) prevention for laparotomy for peritonitis.

NCT ID: NCT05683834 Recruiting - Clinical trials for Infectious Mononucleosis

Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-seronegative Persons

Start date: September 22, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Mono can cause fatigue that lasts more than 6 months, and some people can have severe complications. EBV infection may also contribute to some cancers and autoimmune diseases. Currently, there are no approved therapies or vaccines for EBV infection. Objective: To test a vaccine against EBV. Eligibility: Healthy people aged 18 to 25 years. Design: Participants will be screened in 2 parts. They will have a blood test. If that test shows they have never had an EBV infection, they will have a second clinic visit. They will have a physical exam, with blood and urine tests. A cotton swab will be rubbed on their gums to collect saliva. Participants will receive 2 injections into a shoulder muscle. Some will receive the EBV vaccine. Others will receive a placebo; this contains harmless salt water with no vaccine. Participants will not know which one they are getting. The 2 injections will be 30 days apart. Participants will be asked to record any side effects or symptoms they have between visits. They can do this on paper or online. Participants will return for a follow-up visit 60 days after the first injection. They will have follow-up visits by phone or telehealth after 5 and 8 months. They will return for a physical exam after 13 months. They may come back for an optional physical exam after 2 years. Participants will come to the clinic if they become ill with an EBV infection during the study.

NCT ID: NCT05683457 Recruiting - Clinical trials for Cytomegalovirus Infection

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.

Start date: April 5, 2023
Phase: Phase 2
Study type: Interventional

The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 postHCT through Month 9 postHCT.