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Infections clinical trials

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NCT ID: NCT06025682 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO

INO-FIRST
Start date: April 4, 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about infectious complications in patients affected by B-cell acute lymphoblastic leukemia treated with inotuzumab-ozogamicin (INO). The main question it aims to answer is: • incidence of infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin up to 60 days after the end of treatment

NCT ID: NCT06024421 Recruiting - Infectious Disease Clinical Trials

Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir in Healthy Volunteers

FAVIDOSE
Start date: May 14, 2024
Phase: Phase 1
Study type: Interventional

FAVIDOSE trial is a Phase I randomized, double blind controlled, monocentric, dose escalation clinical trial. The primary purpose of this trial is to evaluate tolerance of high doses of favipiravir for 14 days in healthy volunteers. This trial also looks to characterize favipiravir pharmacokinetics in blood and favipiravir levels in sperm. A pharmacogenetics analysis will be conducted in an attempt to identify genetic variants of metabolism and transport enzymes of favipiravir to explain the inter-individual variability of pharmacokinetic parameters of favipiravir. Three sequential dose levels including distinctive participants: - level 1: D1: 2400 mg BID; D2 to D13: 1600 mg BID and D14: 1600 mg in the morning; - level 2: D1: 2400 mg BID; D2 to D13: 2000 mg BID and D14: 2000 mg in the morning; - level 3: D1: 2400 mg BID; D2 to D13: 2400 mg BID andD14: 2400 mg in the morning. Three study groups of maximum of 8 participants, 6 receiving favipiravir and 2 receiving placebo per dose level, three dose levels proposed. Seven additional participants with the same follow up will be included and randomized (6:1 ratio) at the maximum tolerated dose level to allow a satisfactory accurate characterization of pharmacokinetics and pharmacogenetics of favipiravir and their determinants (maximum 39 participants in total, taking into account 8 participants - 2 per dose level - replaced because loss of follow-up before the end of treatment).

NCT ID: NCT06023940 Recruiting - Clinical trials for Microbial Colonization

Variability in Microbial Response to Dietary Fiber

TRIUMPH
Start date: May 12, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to understand varying in responses to different dietary patterns in healthy people who are getting a health screening colonoscopy. The main questions it aims to answer are: - What is the variability in the change of the microbes in the gut of (1) a provided diet that is high in fiber vs (2) a diet of the participant's choice. - What is the magnitude of fasting changes in glucose and lipids following the short-term, high-fiber feeding period and identify candidate predictive factors (short-chain fatty acids, BMI, sex, starting glucose level) for these changes Participants will be in one of two groups: 1. High-fiber diet group: These participants will have a series of measurements that include: blood biochemistries, body composition measured via DEXA, anthropometrics, surveys and questionnaires, and collection of fecal samples. 2. Normal diet group: These participants will eat a diet that is of their choosing (ad libitum) and will have a series of measurements that include: fecal samples, and questionnaires/surveys including food records.

NCT ID: NCT06023238 Recruiting - Clinical trials for Arthroplasty Complications

Knee Prosthetic Joint Infection Antibiotic Elution

Start date: June 5, 2023
Phase:
Study type: Observational

Patients presenting with prosthetic joint infections of a total knee replacement who are treated with an antibiotic spacer will be observed prospectively for their response to treatment and antibiotic elution profiles will be measured post-operatively utilizing mass spectrometry from synovial fluid acquired as part of standard of care in the management of prosthetic joint infection. Secondary outcomes including post-operative complications, re-operation rates, and re-admission rates will also be compared.

NCT ID: NCT06022887 Recruiting - Obesity Clinical Trials

Time-Restricted Eating and Mindfulness-Based Stress Reduction to Reduce the Risk of Early-Onset Colorectal Cancer

MBSR&TRE
Start date: October 18, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the feasibility of remote time-restricted eating (TRE) and mindfulness-based stress reduction (MBSR) interventions and the preliminary effect on EOCRC-related markers. The main question[s] it aims to answer are: - Is it feasible and acceptable to conduct 8-week remote interventions of TRE, MBSR, and combined TRE+MBSR among young adults with excess adiposity and moderate-to-severe perceived stress? - Will participants in the combined group lose more body weight and reduce their stress levels than those in the remaining groups? - Will participants in the combined group experience better body composition changes and improve their cardiometabolic health compared to those in the remaining groups? - Will participants in the combined group exhibit changes in the microbiome compared to those in the remaining groups? Participants will: - Complete 8 weeks of a TRE intervention - Complete 8 weeks of a remote MBSR intervention Researchers will compare 1. TRE alone; 2. MBSR alone; 3. TRE + MBSR; and 4. Control to see if the study is feasible and acceptable; to see if individuals lose body weight; to see if individual stress levels reduce; to see changes in the microbiome.

NCT ID: NCT06021210 Recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

Letermovir for the Prevention of CMV Infection in HSCT Recipients Based on the Outcome of mNGS

Start date: July 7, 2022
Phase: Phase 2
Study type: Interventional

Letermovir for the Prevention of CMV Infection in HSCT Recipients Based on the Outcome of mNGS

NCT ID: NCT06019312 Recruiting - Colorectal Cancer Clinical Trials

L. Plantarum 299v and Gut Microbiome, Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients

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

Colorectal cancer in periooperative period patients (n=60) will be enrolled to this study. Participants will be divided into 4 groups as follows: - group 1 (n=15) will receive 2 capsules (per day) of L. plantarum 299v L. plantarum 299v (Sanprobi IBS®) for 4 weeks - group 2 (n=15) will receive L. plantarum 299v (2 capsules per day) and inulin (4 g) for 4 weeks - group 3 (n=15) will receive placebo (2 capsules per day) and inulin (4 g) for 4 weeks - group 4 (n=15) will receive placebo (2 capsules per day) for 4 weeks

NCT ID: NCT06018792 Recruiting - Sepsis Clinical Trials

Molecular Culture for the Diagnosis of Pediatric Sepsis

CHAMPIONS
Start date: March 10, 2024
Phase:
Study type: Observational

Babies and children have an increased risk of getting an infection with a bacteria in the bloodstream (sepsis). It is often difficult for the doctor to determine whether a child has an infection of the bloodstream, because the symptoms are often unclear and can also occur in children who are not sick. To determine whether there is an infection, a little blood is currently taken for a blood test (the blood culture) to investigate whether there is a bacteria in the blood. However, it often takes at least 36 hours before the results of this blood culture are available. That is why antibiotics are usually started immediately to treat the possible infection. However, it often turns out that the blood culture is negative after 36 hours, which means that no bacteria have been found in the blood. Usually the antibiotics are then stopped because it turns out that there was no infection at all. There is currently no good test that can predict whether (newborn) children have an infection or not. That is why too many children are currently wrongly receiving antibiotics. These antibiotics can damage the healthy bacteria in the intestines. There are many billions of 'beneficial bacteria' in the intestine. These play an important role in the digestion of food and protect against external infections. Antibiotics aim to kill bacteria that cause inflammation or infection. Unfortunately, antibiotics also kill some of these beneficial bacteria. In addition, unnecessary use of antibiotics contributes to antibiotic resistance. The aim of this research is to investigate whether Molecular Culture, a PCR based test that can identify bacterial pathogens in bodily fluids within 4 hours, has greater accuracy than traditional culturing techniques for bacteria in blood. If proven, this could lead to faster identification or exclusion of sepsis in children.

NCT ID: NCT06017310 Recruiting - Clinical trials for Respiratory Viral Infection

Respiferon Project

Respiferon
Start date: November 11, 2022
Phase:
Study type: Observational

Respiratory viral infections (RVIs) represent a major public health problem and a great burden in terms of morbidity and mortality in children and adults worldwide. To ascertain the source of an infection, microbiology laboratories routinely perform a crucial step: the search for the pathogen through Polymerase Chain Reaction (PCR). Due to the extensive variety of pathogens, testing for the existence of all potential viruses, bacteria, or fungi accountable for the infection is an impractical and time-intensive endeavor. Furthermore, the rise of novel pathogens, exemplified by those accountable for the recent SARS-CoV-2 pandemic, underscores the urgency of promptly developing new innovative diagnostic tests. To address these needs, researchers have dedicated several years to developing indirect methodologies notably centered around utilizing markers derived from the host's immune system. Among these, one particularly promising approach focuses on measuring the expression of interferon-stimulated genes, which are uniquely triggered by viral infections, thereby facilitating viral diagnosis. This methodology's efficacy has been proven in the context of SARS-CoV-2 infections. This study's objective is to assess the functionality of such a tool across a spectrum of Respiratory Viral Infections (RVIs) prevalent within a French population during the winter season.

NCT ID: NCT06016088 Recruiting - Clinical trials for Pseudomonas Aeruginosa

A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection

Start date: April 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.