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Bacterial Infections clinical trials

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NCT ID: NCT04816968 Not yet recruiting - Clinical trials for Severe Bacterial Infections

Antibiotics Continuous Infusion at Home

TAID
Start date: September 2021
Phase: Phase 1
Study type: Interventional

BACKGROUND: The spread of multidrug-resistant bacteria represents a well-known problem, which must be face up by optimizing antibiotic therapy both in terms of choosing the most appropriate drug and of an adequate treatment duration. The method of administration is also a critical element. There are data relating to the maximization of the efficacy of Carbapenems and Piperacillin/Tazobactam by continuous infusion, able to constantly maintain adequate drug concentrations. Several studies, conducted comparing a standard administration of Carbapenem or Piperacillin/Tazobactam to an extended administration or continuous perfusion to evaluate safety and efficacy in terms of mortality reduction, have been documented. The achievement of optimal serum concentrations during continuous infusion has been documented both for Carbapenems and Piperacillin/Tazobactam, and for other types of antibiotics such as Cefepime and Vancomycin. The duration of antibiotic treatment is a critical factor for the prevention of relapses as well as the onset of resistance. The recommended duration of antibiotic treatment varies according to the site of infection and the type of pathogen and is generally between 7 and 14 days, however, in particular cases it is possible that the administration of antibiotics must be longer than one month. In general, the length of hospitalization is associated with a greater likelihood of complications for patients, with a substantial increase in the risk of developing multiple types of complications, such nosocomial infections, bed rest, bedsores, falls, malnutrition and disorientation. It should also be noted that prolonged hospitalization leads to a substantial increase in care costs. The advantage in terms of greater therapeutic success linked to the continuous infusion of some types of antibiotics has been used for the development of home infusion protocols for antibiotic therapy. There are numerous studies that show the feasibility and effectiveness of home infusion antibiotic therapy using elastomeric devices, documenting its substantial equivalence with respect to hospital treatment. The antibiotics for which there is evidence of feasibility are various, including Cefepime, Vancomycin and Piperacillin/Tazobactam. STUDY DESIGN: The study is aimed to patients with severe bacterial infections who have started an antibiotic treatment and are benefiting from such therapy. The purpose of the study is to move the continuation of antibiotic therapy to the home setting once its efficacy and tolerability during hospitalization have been documented, in order to allow the patient a potentially eradicating treatment, of adequate duration without the need of hospitalization. Patients are enrolled when the efficacy and tolerability of the ongoing antibiotic treatment based on Cefepime, Meropenem, Piperacillin/Tazobactam or Vancomycin has been documented. The protocol requires that the patient go to the hospital every morning to replace the elastomer and to carry out a medical examination. Blood chemistry tests, which include at least blood counts, electrolytes, renal function, liver function and inflammation indices are scheduled to be performed at least once a week. Exams can also be done more frequently based on clinical needs. Antibiotic therapy should be carried out until the infection is cured, as per current clinical practice. For the purposes of the study, the patient remains under observation for 30 days after enrollment. Blood samples for the assessment of antibiotic concentrations will be performed in correspondence with the blood chemistry tests performed routinely for patient assessment. In any case, for each patient, a sample is taken for the dosage of the antibiotic used, which will be a single sample in the event of a continuous infusion, or a downstream sample (within one hour of the new antibiotic administration) and peak (30 minutes after the end of the infusion). The pharmacokinetic sampling relating to the outpatient phase will be carried out on the third or fourth day of continuous infusion therapy at the time of the elastomer change.

NCT ID: NCT04809259 Not yet recruiting - Clinical trials for Infection, Bacterial

Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

Start date: January 1, 2024
Phase: Early Phase 1
Study type: Interventional

This study aims to evaluate if meropenem can be administered in outpatients as a continuous infusion using elastomeric pumps and an isothermal pouch maintaining the anti-infective solution between 10° and 15°C for improved stability.

NCT ID: NCT04447937 Not yet recruiting - Multiple Sclerosis Clinical Trials

Immunodeficiency in MS

Start date: June 29, 2020
Phase:
Study type: Observational

The purpose of this study is to identify if there is a relationship between multiple sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in subjects living with MS.

NCT ID: NCT04077606 Not yet recruiting - Clinical trials for Gingival Inflammation

Gingival Inflammatory Response,Bacterial Adhesion and Patient Satisfaction of Ceramo-metallic vs Zirconia Crowns

CairoU
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Ceramo metallic restoration has proved high success rate over past years as considered to be the gold standard while Monolithic zirconia as fixed dental prostheses have gained attention because of their good fracture strength, low wear of the enamel antagonist and pleasant color .Material composition will affect gingival health and biofilm formation which initiate caries and periodontal diseases.

NCT ID: NCT04075344 Not yet recruiting - Clinical trials for Infection, Bacterial

Effect of a Infection Control Program on the Reduction of Bacterial Contamination on NG Tube Feeding in RCHEs

Start date: September 2, 2019
Phase: N/A
Study type: Interventional

Septicaemia is a potential complication of nasogastric (NG) tube feeding contamination (Leanne, 2014; Anderton, 2000) and a major cause of morbidity and mortality in residential care home for elders ( RCHEs) (Leanne, 2014). Although health workers (HWs) and personal care workers (PCWs) are responsible for NG tube feeding and direct care to the residents who are fed by NG tube feeding under supervision of registered nurses (RNs) and enrolled nurses (ENs) in RCHEs, HWs and PCWs unfortunately receive limited training regarding infection control (Ho et al., 2012; NICE, 2012; Duckro et al., 2009; Bankhead et al., 2009). A multimodal ICP could reduce the incidence of NG tube feeding contamination by improving the knowledge and skills of RCHE staff members regarding NG tube feeding (Ho et al., 2012). However, because the intervention described by Ho et al. (2012) was not administered in a randomised manner, potential confounders that could affect the outcomes of interest were not adjusted. To overcome that limitation, the proposed work will establish a well-designed multimodal ICP and explore the effectiveness of this intervention in terms of enhancing the knowledge and skills regarding NG tube feeding of RCHE staff members and consequently reducing NG tube feeding contamination after adjusting for potentially important baseline factors. The proposed research objectives are as follows: 1. To explore the effectiveness of a multimodal ICP for reducing bacterial contamination, as measured by the total bacterial counts on NG tube hubs and fingertips on both hands of RCHEs staff, as well as in enteral milk; and 2. To investigate the effectiveness of a multimodal ICP for improving the knowledge and skills of RCHEs staff members regarding infection control measures during NG tube feeding in RCHEs setting.

NCT ID: NCT03948308 Not yet recruiting - Infection Clinical Trials

Alteration of the Immune Response in Bacterial Infection

ARIIBACT
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The pilot study "ARIIBO" was conducted to analyze changes in immune parameters reported in obese subjects, which had never been the subject of a global study outside of an infectious context, and studied in period septic only sporadically. This study was intended to contribute to a better understanding of the probably adverse impact of obesity on the immune response to bacterial infections, and to describe a specific immunological profile of an infectious excess risk in obese subjects. In terms of infection, obesity is a risk factor due to "mechanical" and pharmacodynamic variations, but also to the immune system. One of the best studied immunological parameters in obese patients, leptin resistance, is associated with a decrease in innate and adaptive immunity through a modification of the lymphocyte and cytokine profile. It is important to compare the data collected in obese patients infected (first study called "ARIIBO"), with those of non-obese subjects presenting the same type of infection, which will be included in the study "ARIIBACT"

NCT ID: NCT03931876 Not yet recruiting - Clinical trials for Bacterial Infections

A Single Ascending Dose Study of AV-006 in Healthy Subjects

Start date: June 24, 2019
Phase: Phase 1
Study type: Interventional

Characterization of the single dose pharmacokinetics of AV-006 in healthy male and female subjects. Description of safety and tolerability of AV-006 in healthy subjects

NCT ID: NCT03923803 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Diagnostic Values of C-reactive Protein and Procalcitonin in Predicting Bacterial Infection in Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Start date: July 2019
Phase:
Study type: Observational

Chronic obstructive pulmonary disease is a serious disease . Exacerbations of Chronic obstructive pulmonary disease is an acute worsening condition of Chronic obstructive pulmonary disease, which always accompanied by clinical symptoms such as, shortness of breath and increased production of sputum. Respiratory infection (bacteria or viruses or mixed) is thought to be the main cause in most exacerbations.

NCT ID: NCT03915275 Not yet recruiting - Clinical trials for Bacterial Infections

Clinical Impact of 16S rDNA PCR

CI16DP
Start date: May 1, 2019
Phase:
Study type: Observational

The main objective of this study is to evaluate the impact of a positive 16S rDNA PCR in various sites on patient's management. The secondary objectives of the protocol are: - to evaluate bacterial identification performance - to evaluate the effect of previous antibiotic therapy - to analyze the management of discordant results between 16S PCR and culture identification

NCT ID: NCT03857295 Not yet recruiting - Clinical trials for Bacterial Infections

Infections Following NeuroSurgery (INS)

INS
Start date: March 11, 2019
Phase:
Study type: Observational

Neurosurgery (NS) is essential for the treatment of various diseases such as malignant tumors, vascular conditions, spinal stenosis or trauma. However, NS can be complicated by the onset of infections, directly related to surgery or to hospitalization. Little is known regarding the epidemiology, the optimal treatment regimens and the outcome of infections following NS (I-NS). The study aims at investigating the clinical and microbiological characteristics as well as the outcomes of I-NS occurring at a single Institution (IRCCS Neuromed, Pozzilli, Italy) during the period 2016-2018. Patients with at least 1 infective episode requiring antimicrobial therapy are included in this retrospective observational study.