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Infections clinical trials

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NCT ID: NCT06056947 Completed - Bacterial Vaginosis Clinical Trials

Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule

One-Shot
Start date: July 20, 2020
Phase: Phase 3
Study type: Interventional

Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.

NCT ID: NCT06055777 Recruiting - Infections Clinical Trials

Study of the Safety, Tolerability, and PK of SZEY-2108 Administered Intravenously to HVs in SAD and MAD Cohorts

Start date: September 7, 2023
Phase: Phase 1
Study type: Interventional

This phase 1 study was designed to evaluate the safety and tolerability of SZEY-2108 in single and multiple intravenous infusions, the pharmacokinetic profile of SZEY-2108 after single and multiple intravenous infusions, and the effect of exposure to SZEY-2108 after a single intravenous infusion on QT/QTc interval. Metabolites in each biological matrix (blood, urine, feces) and excretion characteristics (feces) after SZEY-2108 were analyzed.

NCT ID: NCT06055712 Enrolling by invitation - Infections Clinical Trials

Antibiotic Prophylaxis in Pediatric Open Fractures

Start date: September 11, 2023
Phase: Phase 4
Study type: Interventional

This research will involve a prospective study on infection rates after grade 1 or 2 open fractures in the skeletally immature pediatric population. There will be 3 arms: one dose intravenous cefazolin, 24 hours intravenous cefazolin, and 24 hours intravenous cefazolin plus 5 days of oral cephalexin.

NCT ID: NCT06055699 Not yet recruiting - Psoriasis Clinical Trials

Association Between the Occurrence of a Clinical RElapse and Gut MIcrobiota Modifications: a Cohort Study of Patients With pSOriasis

REMISSIOn
Start date: March 1, 2024
Phase:
Study type: Observational

The human microbiota corresponds to an extremely rich and varied set of microorganisms that colonize our various epitheliums from birth, including the intestine, lungs and skin, where they interact continuously with our immune system. Changes in microbial composition and function, termed dysbiosis, have been linked to alterations in immune responses and to disease development, such as psoriasis. Recent research has shown that the gut microbiota can condition the therapeutic response to checkpoint inhibitors and that fecal microbiota transplant overcomes resistance to these therapy, suggesting a direct role for the microbiota in the ability to shape a therapeutic immune response. Antibiotic exposure during the course of cancer therapy negatively correlates with patients' response to anti-PD-1 treatment response, thus highlighting the link between the enrichment of specific microbial taxa in intestines and the response to immunotherapy. This observation suggests that treatments capable of modulating microbial networks and promoting specific bacterial clades may modulate the host's immune response. Hence, beyond their expected effect in the targeted tissue, part of the therapeutic effect of drugs could rely on this mechanism. In psoriasis patients, observational studies suggest that gut microbiome is altered differently after the use of anti-IL17 or anti-IL23 biologic agents. Main objective: To determine the evolution of microbial composition of fecal samples issued to patients who responded to a biologic agent (IL-17 inhibitors, IL-23 inhibitors) and have stopped their treatment for 2 to 4 weeks before the index date, at baseline and 6 months or clinical relapse after treatment discontinuation Design of the study: Prospective french multicentre observational cohort study Population of study participants: Patients with psoriasis in remission after IL23i or IL17inhibitor treatments and who have stopped their medication for 2 to 4 weeks. Number of participants included: 50 adult patients considered in remission and have stopped for at least 2 weeks and a maximum of 4 weeks, one of the following biologic agent: secukinumab, ixekizumab, brodalumab, bimekizumab, guselkumab, tildrakizumab, or risankizumab

NCT ID: NCT06052540 Active, not recruiting - Clinical trials for Upper Respiratory Tract Infection

Probiotic Supplementation in Children Affected by Upper Respiratory Infections

PROBIOS2021
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The goal of this randomized non-pharmacological Intervention study is to evaluate the effects of probiotic supplements (Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, Lactobacillus rhamnosus HN001) on children affected by upper respiratory tract infections. The main questions it aims to answer are: - probiotic formulation can reduce intensity and duration of fever in children affected by upper respiratory tract infections - probiotic formulation can influence the gut microbiota composition in children affected by upper respiratory tract infections Participants will be asked to take probiotic supplements or placebo for 14 days and to collect three fecal samples: before probiotic supplementation (T0), 14 days after probiotic supplementation (T1), and 12 months after the enrollment (T2).

NCT ID: NCT06052033 Recruiting - HPV Infection Clinical Trials

Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection

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

Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.

NCT ID: NCT06051513 Recruiting - Clinical trials for Carbapenem-Resistant Enterobacteriaceae Infection

Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection

Start date: September 21, 2023
Phase: N/A
Study type: Interventional

Colistin can be used to treat the infection caused by carbapenem-resistant enterobacteriaceae(CRE). In China, patients diagnosed with Hospital-acquired-pneumonia (HAP)or bloodstream infection caused by CRE are recruited, and randomly assigned to two groups, and in one group the patients accept treatment with colistin, however in another group, the patients accept treatment without colistin. The efficacy and safety of the treatment between the two groups are compared.

NCT ID: NCT06050824 Completed - H. Pylori Infection Clinical Trials

A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection

Start date: July 21, 2022
Phase: Phase 4
Study type: Interventional

All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies. The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography. About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study. All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively. Biopsies will be classified using the Updated Sydney system of classification of gastritis

NCT ID: NCT06050148 Recruiting - Clinical trials for Recurrent Urinary Tract Infection

Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

FMT-UTI
Start date: August 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study investigates Faecal microbiota transplantation (FMT) in prevention of recurrent urinary tract infections (UTIs) caused either by sensitive E. coli or ESBL-E. coli.

NCT ID: NCT06049771 Recruiting - Clinical trials for Carbapenem-resistant Enterobacteriaceae

The Population Pharmacokinetics Study of Tigecycline and Pharmacokinetics- Pharmacodynamics Index in Patients With Carbapenem Resistant Enterobacteriaceae Bloodstream Infection

Start date: September 17, 2023
Phase: N/A
Study type: Interventional

Carbapenem-resistant Enterobacteriaceae (CRE) are an urgent global public health problem. Patients who were infected caused by CRE bloodstream infection were high mortality up to 40%. The National Antimicrobial Resistance Surveillance Center, Thailand (NARST) reported CRE increased from 1.1% to 17.9%. For carbapenemase producing CRE in Thailand was reported blaNDM 47.33%, blaOXA-48 43.33% and blaNDM+blaOXA-48 6.67%. Tigecycline (TGC) was a glycylcyclines antibiotics. High dose tigecycline (HD-TGC) loading dose 200 mg then TGC 100 mg q 12 h via intravenous improve clinical cure in critically ill patients and reduce mortality in carbapenem resistance Klebsiella pneumoniae bloodstream infection compared with standard dose therapy. TGC has susceptibility to CR-KP 79.6% and has an activity to blaNDM, blaKPC and blaOXA-48 carbapenemase producing CRE. However, TGC has clearance (CL) 0.2-0.3 L/h/kg, and high volume of distribution (vd) 2.8-13 L/kg resulted in low levels of TGC in plasma. Moreover, the pharmacokinetics of TGC in critically ill was limited and inconsistent with the previous study. Now pharmacokinetics-pharmacodynamics index (PK/PD index) of TGC for CRE bloodstream infection was not reported. This study aims to study the population pharmacokinetic and PK-PD index of TGC in patients who were CRE bloodstream infection to increase the success rate of treatment.