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NCT ID: NCT05950984 Recruiting - Sepsis Clinical Trials

Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)

MD-PK
Start date: October 30, 2023
Phase:
Study type: Observational

Getting the right dose of antibiotic promptly is an important part of treating infections. Unfortunately, when an infection is severe (sepsis) the body changes how it processes antibiotics. Consequently, some people with severe infection retain antibiotics for too long (risking adverse effects), whilst others excrete antibiotics too quickly (risking under-treatment). Mathematical models can help researchers understand drug handling variability (known as pharmacokinetics) between people. These models require very accurate information about drug administration and drug blood concentration timings. Researchers usually rely on someone recording these timings, but recording errors can make models inaccurate. We would like to understand if using data from routinely used electronic drug infusion devices (recording the exact time of administration) can improve the accuracy of pharmacokinetic models. We intend to investigate this with an antibiotic (vancomycin) that clinicians already routinely monitor blood concentrations for. Adults and children treated at St George's Hospital intensive care units will be invited to participate in the study which will last for 28-days within a 14-month period. Participants will donate a small amount of extra blood and provide researchers access to their clinical data. Blood will be taken at special times during vancomycin treatment from lines placed as part of standard treatment, minimising any pain or distress. There will be no other changes to patient's treatment. In the future, data from this study might help change the way we dose antibiotics. The National Institute for Health and Care Research and Pharmacy Research UK are supporting the study with funding.

NCT ID: NCT05950607 Recruiting - Alzheimer Disease Clinical Trials

Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0

TRAIN-AD 2
Start date: November 13, 2023
Phase: Phase 4
Study type: Interventional

The goal of this pragmatic cluster randomized clinical trial is to compare management of suspected infection in nursing home residents with dementia The main questions it aims to answer whether residents with dementia in nursing homes randomized to use a multicomponent intervention to optimize suspected infection management ( versus usual care) use less antibiotics and fewer burdensome interventions.

NCT ID: NCT05949398 Recruiting - HPV Infection Clinical Trials

Evaluation of the Prevalence of Oral HPV Infection in Patients Who Are Positive to the PAP-test

Start date: March 1, 2021
Phase:
Study type: Observational

The present cross-sectional study aims to assess the prevalence and type distribution of oral HPV infection in PAP-test-positive women aged ≥18 years. The means used in the present study will be the use of anamnestic questionnaires and exfoliative cytology tests at predetermined oral mucosal sites (lingual belly and dorsum, palate, and buccal mucosa).

NCT ID: NCT05948592 Recruiting - Clinical trials for Diabetic Foot Infection

Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection

REVERSE2
Start date: November 8, 2023
Phase: Phase 2
Study type: Interventional

TP-102 is a novel bacteriophage cocktail comprised of 5 (five) lytic bacteriophages against Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii. TP-102 is being developed for topical treatment of patients with wound infections including chronic ulcers; applied every other day (three times weekly (TIW)).

NCT ID: NCT05942157 Recruiting - Sepsis Clinical Trials

Therapeutic Drug Monitoring in Patients With Difficult-to-Treat Gram-Negative Bacterial Infections

TDM-RCT
Start date: March 29, 2023
Phase: N/A
Study type: Interventional

A prospective, open-label, randomized controlled trial will be conducted to evaluate a novel TDM-guided therapy in management of DT-GNB infections. We hypothesize that TDM-guided antibiotic therapy will reduce 14-day all-cause mortality by 6% (absolute risk reduction) in septic patients with DT-GNB infections, when compared to standard therapy. TDM for 11 antibiotics will be performed for all trial patients although test information will be withheld for the standard therapy arm. The primary aim is to compare the 14-day all-cause mortality rates of novel TDM-guided antibiotic dosing versus standard therapy.

NCT ID: NCT05930639 Recruiting - Clinical trials for Bariatric Surgery Candidate

The Effect of the Care Bundle to be Applied to Obesity Surgery Patients on Surgical Site Infection and Patient Comfort

Start date: June 12, 2023
Phase: N/A
Study type: Interventional

One of the most effective treatment methods of obesity is surgery. Bariatric surgery is classified as a clean-contaminated wound. The expected benefit from surgery is weight loss. However, surgical site infection is among the complications. Although many methods are applied to reduce these rates, it is not very possible to reduce them to zero. It is predicted that the incidence of infection will decrease with surgical care packages created from the combination of evidence-based interventions applied. This study was a randomized controlled trial designed to determine the effect of the Surgical Site Infection (SSI) prevention package on SSI and patient comfort in patients undergoing bariatric surgery. The questions to be answered by the research are; - What is the effect of the care package applied to patients undergoing bariatric surgery on surgical site infection? - What is the effect of the care package applied to patients undergoing bariatric surgery on comfort? .Patients aged 18 and over who have had bariatric surgery (sleeve gastrectomy) will be taken from a private hospital in Kayseri. All surgeries will be performed by the same surgeon. The care package (identification of risk factors, antibiotic prophylaxis, normothermia, normoglycemia and patient education) prepared for the experimental group will be applied. On the 30th day, the patient is called by phone and the surgical site infection findings are questioned.

NCT ID: NCT05929378 Recruiting - Chronic Pain Clinical Trials

A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Gilbert Type III Inguinal Hernia

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

This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with type Ⅲ gilbert inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.

NCT ID: NCT05927311 Recruiting - Joint Infection Clinical Trials

Side Effects of Antibiotics in Bone and Joint Infections

PROSEAB
Start date: August 11, 2023
Phase:
Study type: Observational

Treatment for bone and joint infection (BJI) is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.

NCT ID: NCT05923333 Recruiting - Hiv Clinical Trials

B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV

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

The primary objectives of this study are to evaluate the effect of early-life B. infantis Rosell®-33 supplementation in infants exposed to HIV on: - gut microbiome composition and diversity at 4 weeks of life - markers of intestinal inflammation and microbial translocation at 4 weeks of life - Th1 cytokine responses to BCG at 7 weeks and 36 weeks of life The secondary objectives include to evaluate the effect of B. infantis Rosell®-33 supplementation on: - longitudinal succession of the gut microbiota composition, diversity and function - relative and absolute abundance of B. infantis in infant stool during the first 36 weeks of life - stool metabolome - T cell subset ontogeny during the first 9 months of life. Exploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves: - infant growth - all-cause morbidity - neurodevelopment during the first 9 months of life - antibody responses to early childhood vaccines

NCT ID: NCT05920304 Recruiting - Infections Clinical Trials

Early Discharge - Evaluating a Virtual Hospital at Home Model

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

This controlled clinical trial will be part of a larger, 'virtual hospital-at-home' (vHaH) project called Influenz-er. vHaH is a care model designed to deliver medical care at home, as a substitute for a continued conventional inpatient hospital admission. The overall aim of Influenz-er is to develop, implement and evaluate a novel Hospital at Home model, that will enable safe and satisfactory admission of hospitalised patients including epidemic patients in their homes.