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Bacterial Infections clinical trials

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NCT ID: NCT06391463 Enrolling by invitation - Clinical trials for Multidrug Resistant Bacterial Infection

Multi-resistant and Spore-forming Bacteria in a Neonatal Intensive Care Unit

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

Preventing the spread of multidrug-resistant bacteria (MRB) is a major challenge for hospitals today. MRB are defined as bacteria that combine several resistance mechanisms to different families of antibiotics, thus limiting therapeutic possibilities in the event of infection. The spread of MRBs is particularly prevalent in hospital units caring for fragile patients, such as neonatal units. Preventing the spread of MRBs is of prime importance in these units, in order to limit the number of infections caused by these germs. Newborns are at risk of infection due to intrinsic factors such as an immature immune system and fragile skin, as well as extrinsic factors such as mechanical ventilation and intravascular catheters. In Germany, a 2012 KRINKO agreement encourages neonatal units to monitor MRB carriage on a weekly basis. This measure enables early detection of MRB colonization outbreaks in neonatal units. In France, MRB carriage monitoring in neonatal units is not systematic. Spore-forming bacteria also require close monitoring in neonatology, as they do not strictly meet the definition of MRB, but represent a major threat to newborns. The main spore-forming bacterium of medical interest is Bacillus cereus (BC), which is responsible for serious infections in premature infants. BC is resistant to the use of hydro-alcoholic solutions. The origin of these BC infections remains controversial, with numerous studies in the international literature suggesting a link between BC infections and contamination of breast milk given to infants in neonatal units. The role of environmental contamination has also been studied. The potential seriousness of these BC infections justifies the systematic detection of the carriage of this spore-forming bacterium in routine coprocultures, in the same way as other MRB germs. In the neonatal unit at Hôpital de la Croix Rousse, MRB and BC are routinely tested on patient arrival, and then weekly until discharge. If MRB or BC germs are found in children's stools reinforced specific hygiene measures are implemented to prevent cross-transmission in this open-bay unit with little space between incubators. Reinforced specific hygiene measures represent a time constraint for the nursing team, for parents and a financial burden for the neonatal unit. However, to our knowledge, there are no international or national recommendations concerning the duration of stools reinforced specific hygiene measures. Our clinical experience has shown that the persistence of pathogenic germs in stools seems to vary in duration depending on the microorganism. To better determine the optimal duration of reinforced specific hygiene measures, as it is costly in terms of work time, parental stress, and hospital expenses due to reinforced hygiene conditions during the isolation period.

NCT ID: NCT06188988 Enrolling by invitation - Clinical trials for Respiratory Viral Infection

Viral Infections and Airway Microbiome in Young Children With Cystic Fibrosis

Start date: November 1, 2023
Phase:
Study type: Observational [Patient Registry]

Cystic fibrosis (CF) is the most common hereditary life-threatening condition in Belgium. Because of a dysfunctional cystic fibrosis transmembrane conductance regulator (CFTR) channel, chloride is unable to move to the cell surface and mucus becomes more viscous. Consequently, CF patients are not able to clear their lungs efficiently, and trapped bacteria can lead to chronic infection and inflammation of the lungs, and ultimately respiratory failure. CF lung disease starts at birth due to muco-inflammatory processes and is associated with a significantly altered microbial colonization of the infant airways compared to infants without CF. Additionally, young children with CF suffer from viral infections as often as their healthy peers, but the episodes are more severe and often prolonged. Moreover, frequent viral infections in children with CF contribute towards a more pathogenic airway microbiome at a young age. Although this link has been previously reported, the exact mechanisms by which this occurs need to be elucidated. A pulmonary exacerbation in CF is characterized by an increase in respiratory symptoms, general symptoms and a decline in lung function. Most young children with CF suffer from a mean of 4 exacerbations per year for which antibiotics are prescribed. Despite the current novel therapies in CF, treatment of respiratory infections stay relevant and is a greater challenge with increasing survival. The key objective of this study is to gain insights into the mechanisms by which viral infections leading to pulmonary exacerbations induce a more pathogenic microbiome in young children with CF. About forty participants will be recruited at the paediatric CF clinic of the Antwerp University Hospital. Inclusion criteria are an age of less than 5 years and a diagnosis of CF. There are no exclusion criteria. Duration of the study is 1 year to cover for seasonality of clinical symptoms. Study visits are scheduled at 3-month intervals corresponding with the regular follow up, or unscheduled during an acute pulmonary exacerbation. From all participants, two oropharyngeal swabs (for microbiome analysis and for immunological/mucin analysis) will be collected at set time points. For the linking of the laboratory data to the clinical characteristics, we will examine demographics, environmental exposures, and disease markers of CF. Next to the collection of the oropharyngeal swabs, a history, physical examination, and technical investigations will be performed at the study visits.

NCT ID: NCT05285046 Enrolling by invitation - Clinical trials for Bacterial Infections

Phenotypic Profile and Molecular Mechanism of Resistance in Carbapenemase-producing Enterobacterales and Pseudomonas Aeruginosa Isolates From Brazilian Hospitals: Implications for the Introduction of IMIPENEM-RELEBACTAM

Start date: April 1, 2022
Phase:
Study type: Observational

The global dissemination of carbapenem-resistant Enterobacteriaceae (CRE) and Pseudomonas aeruginosa (CRPA) are a significant threat to health care, especially for severely ill patients. Antibiotics currently used to treat CRE and CRPA infections are usually toxic and not very effective. Novel treatments include beta-lactamase inhibitors with broad-spectrum activity, among them IMI-REL. IMI-REL is a promising molecule due to the ability of REL to diminish carbapenem MICs to the susceptible range, potentially restoring the activity of this potent drug. However, few studies have systematically examined IMI-REL activity against a diverse clinical collection of CRE and CRPA strains, in particular from a region where the resistance is high, and the main mechanisms are in general unknown (Brazil- Latin America). As the use of molecular diagnostics becomes increasingly available in clinical settings, it is crucial to identify molecular markers predicting antimicrobial efficacy to guide therapeutic decision-making. In the present study, we will acess different species of CRE and CRPA from clinically relevant isolates to determine if the species, clonal lineage, and resistance gene profile, have influence to the response to IMI-REL.

NCT ID: NCT04764058 Enrolling by invitation - Clinical trials for Bacterial Infections

Efficacy and Safety of Colistin Based Antibiotic Therapy

Start date: September 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the efficacy and safety of antibiotic combinations containing Colistin in the treatment of children with multidrug-resistant gram negative infections admitted in the pediatric surgery intensive care unit. The main outcome measure is clinical and microbiological responses to therapy. The secondary outcome is the occurrence of adverse events during Colistin combination treatment.

NCT ID: NCT04707092 Enrolling by invitation - Clinical trials for Surgical Site Infection

Use of Preoperative and Postoperative Antimicrobial Treatment

Start date: June 1, 2021
Phase: Phase 4
Study type: Interventional

In this study, patients undergoing ear surgery (cochlear implantation, stapedotomy, tympanoplasty) will be randomized to one of two antibiotic treatment groups. One group will receive a single treatment with an antibiotic at induction The other group will receive the single intravenous treatment, plus a one week course or oral antibiotic

NCT ID: NCT04633603 Enrolling by invitation - Anxiety Clinical Trials

LázBarát™ (FeverFriend™) Projekt: Attitude Toward Fever and Its Change in the Healthcare System

Start date: January 15, 2020
Phase:
Study type: Observational [Patient Registry]

The positive effects of fever are supported by a number of physiological, pathophysiological and clinical evidence. However, the negative attitude toward fever is widespread and have become persistent. According to sociological research, this is based on two main factors: comfort and fear. To change this negative attitude, awareness needs to be raised and the attitude toward fever among health care workers and the lay public needs to be reframed positively. Furthermore, the role of media users is essential, especially among the young generation. The current Hungarian recommendation/protocol is valid since 2011 (Professional protocol of the Ministry of National Resources: Caring for a child with fever, the recommendation of the College of Pediatric and Pediatric However, the practical implementation among health professionals and the laity public is low. Based on this protocol and current international guidelines (NICE) clinicians developed a protocol and register, where parents and caregivers can document the symptoms and runoff of fever as well as receive feedback on severity and appropriate management. The project aims to increase the evidence-based (EBM) guideline adherence, to reduce the unnecessary use of antipyretics and antibiotics, as well as the load on the current healthcare system. The documentation of the collected data allows the investigators to map and analyze (stats) socio-demographic behavior both on individual and societal level.

NCT ID: NCT04178915 Enrolling by invitation - Sepsis Clinical Trials

Study of Leukocyte Immunophenotype and the Lipid Transport System as Predictive Biomarkers of Severe Bacterial Infections

Start date: July 1, 2019
Phase:
Study type: Observational

Current study evaluates the relationship between cell immunity and lipid transport systems in patients with severe bacterial infections (on the model of pneumonia, infective endocarditis, sepsis) in order to develop new methods for predicting the course and outcome of severe bacterial infections.

NCT ID: NCT04055922 Enrolling by invitation - Clinical trials for Gram-Negative Bacterial Infections

Comparison of Solid Organ Transplant

Start date: May 3, 2018
Phase:
Study type: Observational

Solid organ transplant (SOT) recipients have increased incidence of infections with MDRO pathogens. This difference leads to a disparity in antibiograms between SOT recipients and other hospitalized patients.

NCT ID: NCT01646411 Enrolling by invitation - Clinical trials for Acute Viral Infections

300 Antibody Diagnostic Test Kit

Antibody 300
Start date: August 2012
Phase: N/A
Study type: Observational

For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically "normal" serum and whole blood matched specimens for specificity and sensitivity determination for each marker. The positive samples must be IgM positive using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.