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Bacterial Infections clinical trials

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NCT ID: NCT06220370 Not yet recruiting - Clinical trials for Infection, Bacterial

PATH Study: People With Injecting Related Infections: Assessing Treatment Outcomes for Those Who Are Hospitalised.

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

We seek to characterise the burden and outcomes of and understand the current experience of people who inject drugs admitted to hospital with invasive injecting-related infections, in order to implement and evaluate strategies to improve completion of therapy and reduce patient-directed discharges, with ultimate benefit to the patient and health service.

NCT ID: NCT06193512 Not yet recruiting - Clinical trials for Mechanical Ventilation Complication

Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a Pilot Study

EASIER
Start date: March 15, 2024
Phase: N/A
Study type: Interventional

We propose a randomized pilot/feasibility study comparing oral care treatment as usual (TAU) with Swiftsure SwishKit plus oral care TAU on the presence and magnitude of bacterial load in the oropharyngeal space in orotracheally intubated patients. The trial will be conducted with IRB approval and written consent from patient or its legal representative.

NCT ID: NCT06166381 Not yet recruiting - Clinical trials for Infection, Bacterial

Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction

Start date: January 25, 2024
Phase: N/A
Study type: Interventional

An anterior cruciate ligament (ACL) tear is one of the knee joint's most common soft tissue injuries [1]. It is frequently injured in non-contact and some contact competition sports and even during ordinary life activities. With an annual incidence of 68.6 per 100,000 person-years, ACL tears remain a common orthopedic injury [2]. Females are two to eight times more likely to develop ACL tears in sports compared to men who play the same particular sports [3]. Most highly demanding persons and those who develop frequent instability of their knee require reconstructive surgery on the ACL to prevent early degenerative changes in their knees. This is done by completely removing the torn or ruptured ACL and replacement with a piece of tendon or ligament (graft) [4]. Post-operative infection may occur in 0.14-2.6% of ACL reconstruction despite intravenous antibiotics prophylaxis [5,6]. The deep infection results in poor outcomes with pain, stiffness, arthrofibrosis, and articular cartilage degeneration [7,8]. Few studies reported improved outcomes of infection control when the autograft presoaked in vancomycin solution during the preparation process outside the body before being transferred to the knee of the patient [9-13]. Systematic reviews and meta-analysis showed that all the articles discussing the outcome of vancomycin presoaked autograft in ACL reconstruction surgery were case series, observational retrospective, prospective comparative, or case-control studies [14,15]. Randomized control trial (RCT) provides the strongest evidence among the primary research studies to confirm the effectiveness of a new method of treatment [16,17]. To date, there is no available RCT study in this field.

NCT ID: NCT06157242 Not yet recruiting - Clinical trials for Bacterial Infections

PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment

Start date: June 1, 2024
Phase: Phase 1
Study type: Interventional

A Phase 1, open-label, single-dose study to determine the safety and pharmacokinetics of ORAvance (ceftibuten/xeruborbactam oral prodrug [QPX7831]) in participants with renal impairment

NCT ID: NCT06143657 Not yet recruiting - Clinical trials for Infection, Bacterial

Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device

Start date: January 10, 2024
Phase:
Study type: Observational

The investigators have developed an analysis AI for Gram staining. In this study, the investigators will compare the testing accuracy of automated Gram staining equipment with AI with the testing accuracy of laboratory technicians. Based on the results, the investigators will examine the possibility of clinical application of the automated Gram staining device.

NCT ID: NCT06135350 Not yet recruiting - Clinical trials for Gram-Negative Bacterial Infections

Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV

Start date: November 2023
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the clinical and antibacterial efficacy, safety and pharmacokinetics of the drug Fluorothiazinone compared to placebo to prevent nosocomial gram-negative bacterial infections with participation of patients on mechanical ventilation. The main objectives of this study are: - Evaluation of the clinical and antibacterial efficacy of the drug Fluorothiazinone in combination with standard measures for the prevention of nosocomial infections compared to placebo in combination with standard measures for the prevention of nosocomial infections for the prevention of nosocomial infections caused by bacterial gram-negative flora in patients on mechanical ventilation. - Evaluation of the safety and tolerability of the drug Fluorothiazinone in patients on mechanical ventilation. - Evaluation of the pharmacokinetics (in whole blood) of the drug Fluorothiazinone with a single daily dose of 2400 mg/day. Researchers will compare results for the treatment and the placebo arms.

NCT ID: NCT06103500 Not yet recruiting - Sepsis Clinical Trials

Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis

IDEAS-CRXO
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

As antibiotic resistance increases globally, it becomes more difficult to select empiric antibiotic therapy, particularly in patients with sepsis who stand to benefit from early adequate treatment. In particular it is difficult for clinicians to balance antibiotic stewardship principles (the need to avoid unnecessary prescribing of antibiotics that have an excessively broad spectrum of activity that favour resistance development) and under treatment. The integration of multiple risk variables for resistance are hard for clinicians to translate into clinical action, and is seemingly at odds with the natural inclination to provide heuristic/emotion-based antibiotic selection. The inappropriate treatment of sepsis is not uniformly too broad, or too narrow, and there is a need to optimize and tailor selection of antibiotic therapy to each patient, such that those that are at risk for resistant organisms receive broad therapy, and those that are not at risk, receive narrower antibiotic agents. Clinicians need support picking the right antibiotic for each patient, and from this they can potentially drive reduction of unnecessarily broad antibiotic prescribing while preserving adequacy of treatment. Individualized clinical prediction models and decision support interventions are promising approaches that meet these needs by improving the classification of patient risk for antibiotic resistant or susceptible infections in sepsis. Unfortunately, few have been validated in the clinical setting and larger rigorous studies are needed to provide the evidence to support broader clinical adoption. The investigators will perform a cluster randomized cross-over trial of an individualized antibiotic prescribing decision support intervention for providers treating hospitalized patients with suspected sepsis. The aim of this trial is to determine whether a stewardship led clinical decision support intervention can improve antibiotic de-escalation in patients with sepsis while maintaining or improving adequacy of antibiotic coverage. This decision support intervention will be based on a combination of proven decision heuristics (for Gram-positive organisms) and modelled predicted susceptibilities (for Gram-negative organisms) that are individualized to the patient. The primary outcome will be the proportion of patients de-escalated from their initial empiric regimen within 48 hours.

NCT ID: NCT05993442 Not yet recruiting - Clinical trials for Infection, Bacterial

Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in Neonatal Intensive Care.

NeoDeco
Start date: February 2024
Phase: N/A
Study type: Interventional

NeoDeco is a pragmatic, multicenter, parallel group, cluster randomised hybrid effectiveness-implementation study with baseline assessment, wash-in period and staggered randomisation. All sites will be offered the implementation support for optimised Kangaroo Care (KC) as part of the study; however, intervention sites will be randomised to immediate receipt of implementation support whereas standard care sites will be offered this after the study period.

NCT ID: NCT05988177 Not yet recruiting - Clinical trials for Hemophagocytic Lymphohistiocytoses

Efficacy and Safety of Carrimycin Tablets in HLH Patients With Carbapenem-resistant Infections

Start date: August 30, 2023
Phase: N/A
Study type: Interventional

This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.

NCT ID: NCT05922124 Not yet recruiting - Clinical trials for Carbapenem Resistant Bacterial Infection

Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii

CASCADE
Start date: April 1, 2024
Phase: Phase 4
Study type: Interventional

Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will be compared to patients treated treated with colistin alone or colistin combined with meropenem.