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NCT ID: NCT06072352 Not yet recruiting - Clinical trials for Maternal Infection During Pregnancy

Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

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

Maternal infection during pregnancy is one of the leading causes of maternal mortality, accounting for 10.7% of maternal deaths worldwide (~37,000 annually). Majority of maternal infection occurs during intrapartum (36%) and postpartum (47%) period, of which the genital tract is the source of infection in 89% of intrapartum and 54% of postpartum sepsis. Introduction of skin flora into the genital tract during vaginal examination in women with rupture of membranes or active labour may cause intrapartum and puerperal sepsis. We hypothesize intrapartum vulval and perineal cleansing before vaginal examination could reduce the chance of peripartum infection caused by introducing the skin flora to intrauterine environment. We plan to carry out a randomized controlled trial of intrapartum vulval and perineal cleansing using chlorhexidine, compared sterile water, prior to vaginal examination during labour and its effect on maternal and neonatal sepsis.

NCT ID: NCT06068517 Not yet recruiting - Clinical trials for Surgical Wound Infection

Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery

CISSI
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Surgical site infections (SSI) are a frequent complication in abdominal surgery. SSI lead to worse outcomes for the affected patients and significantly higher healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) consists of a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. It is currently unclear, if ciNPWT reduces SSI in patients undergoing abdominal surgery. This trial will investigate the effect of ciNPWT on SSI in abdominal surgery.

NCT ID: NCT06065267 Not yet recruiting - Clinical trials for Helicobacter Pylori Infection

Levofloxacin Concomitant Versus Levofloxacin Sequential

Start date: January 2, 2024
Phase: Phase 4
Study type: Interventional

The goal of this trial is to determine the efficacy of levofloxacin based sequential treatment regimen or concomitant levofloxacin based regimens as empirical first-line therapy in the Syrian population

NCT ID: NCT06063629 Not yet recruiting - Clinical trials for Surgical Site Infection

Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Surgical Wound After Abdominal Surgery

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Surgical site infections (SSI) pose a common challenge in the field of surgery. Current evidence and literature do not provide clear consensus whether the use of subcutaneous drainage will help reduce the incidence of SSI in patients who underwent abdominal surgery, especially in wounds that are categorized as contaminated (class 3) or dirty/infected (class 4). The objective of this clinical study is to compare the rate of surgical site infection in contaminated and dirty/infected surgical wounds among patients whose wounds are inserted with subcutaneous drainage and patients who are not inserted with subcutaneous drainage.

NCT ID: NCT06057194 Not yet recruiting - Clinical trials for Infections, Cytomegalovirus

Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.

LETERCOR
Start date: October 2023
Phase: Phase 2
Study type: Interventional

The goal of this quasi-experimental multicenter before-after cohort study, phase II study is to evaluate the efficacy of 12-month letermovir prophylaxis in lung transplant recipients (D+/R-) compared to a historical cohort of lung transplant recipients (D+/R-) who received 12 months of valganciclovir prophylaxis to prevent CMV disease."

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: NCT06045429 Not yet recruiting - Clinical trials for VAP - Ventilator Associated Pneumonia

Oral Care With 3% Hydrogen Peroxide (Oroxid®) in ICU - Effects on the Lower Airway Microbial Colonisation

HyperMICROBE
Start date: May 2024
Phase: Phase 4
Study type: Interventional

HyPerMICROBE is a single-centre, controlled, randomised, prospective, superiority clinical trial to compare the efficacy of daily oral care with 3% hydrogen peroxide (Oroxid®) versus standard of care (0.2% chlorhexidine digluconate) on the cumulative incidence of lower respiratory tract microbial colonisation in mechanically ventilated adult critically ill patients.

NCT ID: NCT06043414 Not yet recruiting - Laparotomy Clinical Trials

Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This randomized control trial aims to compare the efficacy of triclosan-coated barbed suture (TCB) versus conventional non-barbed polydioxanone (PDS) suture in the closure of the abdominal fascia after emergency exploratory laparotomy. The study addresses the common complications of incisional surgical site infections (SSI) and fascial dehiscence (FD) following emergency exploratory laparotomy. The primary objective is to assess the effectiveness of triclosan-coated barbed suture and conventional non-barbed suture in reducing the rates of incisional SSI and FD within 30 days postoperatively. The study population comprises adult patients undergoing emergent laparotomy for traumatic injuries or acute intraabdominal pathology. This prospective, single-blinded randomized control trial will be conducted at Los Angeles General Medical Center. Patients will be randomized to receive either triclosan-coated barbed suture or conventional non-barbed suture for abdominal fascial closure, with a standard closure technique employed. Patients will be followed up for 30 days postoperatively to monitor surgical site infections, fascial dehiscence, and other outcomes. Statistical analysis will be conducted to compare outcomes between the study arms, assessing the efficacy of triclosan-coated barbed suture in reducing the incidence of SSI and FD, along with secondary outcomes.

NCT ID: NCT06039176 Not yet recruiting - Stroke Clinical Trials

Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future

Start date: October 2023
Phase:
Study type: Observational

Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac transplantation. Despite the decreasing size of the newest generation devices leading to a lessened occurrence of adverse events, bleeding and infection still remain a concern for clinicians, as well as a general lack of predictability towards adverse events in individuals with a dLVAD in place. There is a lack of description in the literature currently, regarding the interface between what the pump data provides and what is seen in clinical practice. There also is little known about the effects of what is provided in the pump data, in correlation to quality-of-life following dLVAD implantation. Therefore, the purpose of this study is to prospectively analyze normal and abnormal pump data through pump operations such as suction events, low flow alarms as well as other adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty and other various medical conditions and adverse events as defined by the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical practice application (quality of life, frailty and various medical conditions, and adverse events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate correlations and relationships of longitudinal normal and abnormal dLVAD pump operations data, to demographic and clinical variables. This study is the first study to evaluate HeartMate 3 ® dLVAD pump operations data over time for effectiveness in the clinical practice.

NCT ID: NCT06037122 Not yet recruiting - Clinical trials for Helicobacter Pylori Infection

Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication

Start date: September 2023
Phase:
Study type: Observational

The primary objective of this retrospective study was to assess the efficacy and safety of a bismuth quadruple regimen of a low-dose potassium-competitive acid blocker versus a standard-dose potassium-competitive acid blocker and a standard-dose proton pump inhibitor combined with amoxicillin and clarithromycin as the initial treatment of Helicobacter pylori infection.