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Antimicrobial Resistance clinical trials

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NCT ID: NCT05285657 Completed - Clinical trials for Antimicrobial Resistance

Algorithm Using a Rapid Diagnostic Test for the Management of Childhood Febrile Diseases.

e-MANIC
Start date: February 28, 2022
Phase: N/A
Study type: Interventional

In Sub-Saharan Africa (SSA), fever remains a major public health problem in children. The introduction of malaria rapid diagnostic tests (RDTs) in routine healthcare has greatly improved the management of malaria. However, despite the good attitude of healthcare workers to adhere to malaria RDT test results, persisting hrp2antigen and low sensitivity of pLDH RDT negatively affect antimalarials and antibiotics prescriptions practices. This is one of the main causes of antimicrobial resistance (AMR) and inappropriate management of febrile diseases. To improve the diagnosis of febrile diseases and subsequent prescription of antimicrobials, it is hypothesized that the implementation of an algorithm including a two-step malaria RDT PfHRP2/pLDH supported by point-of-care tests (POCTs) for C-reactive protein, oximetry, and bacterial infection such as Group A Streptococcus, and Salmonella/Shigella, will significantly improve the management of febrile diseases and thereby tackling AMR. To assess the value of the proposed algorithm, an open-label randomized controlled trial with three arms, enrolling febrile children under 5 years is proposed. - In the control arm, febrile children will benefit from a complete clinical examination. Treatment will be done according to the national guideline. - In RDTs decisional algorithm (RDT-DA) arm (intervention), the complete clinical examination will be supported by two-step malaria RDT and bacterial infections RDTs. Prescription will be left to the discretion of the healthcare workers. - In e-algorithm arm (intervention), the complete clinical examination and the outcomes of RDTs (malaria and bacterial infections) will be digitalized. Diagnostic and prescription will be done by the algorithm. A final follow-up visit (day7) will be scheduled for all participants. Patients will be asked to return to the health facilities in case of no improvement. Primary study outcomes will be the proportion of curative case and antimicrobial(s) prescribed in each arm. Secondary outcomes include: (i) adherence of healthcare workers to the algorithm; (ii) adherence of parents/guardian to treatment; (iii) accuracy of the algorithm for the diagnostic of malaria. This project will serve as a path of policy change in the management of febrile diseases and AMR. By relying on existing RDTs available, the implementation of this algorithm will tackle AMR and provide better care. If successful, the project will equip the lead applicant to establish himself as an independent researcher with ability to further build his own research team. The project will also offer training opportunities to young scientists, and further strengthen already existing capacities of the home institute.

NCT ID: NCT05089760 Not yet recruiting - Neonatal Sepsis Clinical Trials

Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China

Start date: January 1, 2024
Phase:
Study type: Observational

Neonatal sepsis remains one of the most important cause of mortality and morbidities in China. This study will establish a prospective registral cohort of all infants with culture-proven neonatal sepsis in Chinese NICUs participating in the Chinese Neonatal Network (CHNN). The microbiology, antimicrobial resistance patterns and neonatal outcomes will be described in detail for this cohort.

NCT ID: NCT04388293 Recruiting - Clinical trials for Antimicrobial Resistance

Using Antibiotics Wisely - An Antimicrobial Stewardship Program

Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

There are significant variations in antimicrobial consumption across Canadian Neonatal Intensive Care Units (NICUs). Inappropriate and overuse of antibiotics can result in antimicrobial resistance and adverse outcomes among vulnerable neonatal populations. There are limited data on broad-spectrum antimicrobial use, multi-drug resistant organisms (MDRO) prevalence, and effective NICU-specific antimicrobial stewardship strategies. The aim of this study is to develop and implement NICU-specific antimicrobial stewardship strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of MDROs.

NCT ID: NCT04182230 Completed - Clinical trials for Antimicrobial Resistance

UROGEN WELL D-ONE : Evaluation of a Novel Diagnostic for Sexually Transmitted Bacterial Infections

Start date: September 5, 2018
Phase:
Study type: Observational

UROGEN WELL D-ONE Principal research question: Can the UROGEN WELL D-ONE assay detect urinary tract infections and urethritis in clinical samples from patients attending Genitourinary Medicine outpatient clinics as accurately as standard laboratory microscopy and culture methodologies, while simultaneously identifying antimicrobial resistance? The primary aim of this study is to evaluate the rapid diagnostic assay UROGEN WELL D-ONE and determine if it can accurately detect infectious organisms causing UTI's and urethritis. Secondary research question: Is the antimicrobial resistance identified by the UROGEN WELL D-ONE assay accurate as compared to determination by the Clinical and Laboratory Standards Institute international guidelines? The secondary research objective will be to assess the accuracy of the breakpoint antimicrobial susceptibility measurement by the assay. This is particularly important with the global increase in antibiotic resistance, when the acquisition of mobile resistance genes to the remaining effective therapeutics is rising internationally.

NCT ID: NCT03794479 Completed - Clinical trials for Antimicrobial Resistance

Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel

Start date: November 5, 2018
Phase:
Study type: Observational

International travel is well reported to be associated with acquisition of multidrug-resistant organisms, however, the impact of colonization of these multidrug-resistant organisms is currently uncertain. As colonization of multidrug-resistant organisms had been demonstrated to be associated with distinct intestinal microbiota composition and travellers constitute a generally healthy population with minimal antibiotics exposure; by evaluating serial stool samples before and after travel, the investigators can delineate a potential causal relationship between host intestinal microbiota and subsequent risk of acquisition of multidrug-resistant organisms.

NCT ID: NCT03479710 Completed - Clinical trials for Antimicrobial Resistance

Fecal Microbiota Transplantation for CRE/VRE

Start date: February 10, 2018
Phase: Phase 2
Study type: Interventional

Multidrug-resistant organisms (MDRO) present an increasingly serious public health threat to the global community.The prevalence of various MDRO, including carbapenem-resistant Enterobacteriaceae (CRE) and vancomycin-resistant Enterococcus (VRE), has been increasing worldwide, and some have become endemic in certain countries. Data from the Hospital Authority showed that the number of carbapenemase- producing Enterobacteriaceae (CPE) cases increased from 36 in 2012 to 134 in 2015. A large outbreak of VRE involving >200 patients was recently reported in a tertiary hospital in Hong Kong. The primary site of colonization and persistence of most MDRO is in the gastrointestinal tract. Carriage can persist for months, with up to 40% of individuals still having colonization one year after hospital discharge. Outbreaks of MDRO have been reported in hospitals and long-term care facilities. Around 10% of patients colonized with MDRO would develop clinical infections by the same organism. Infections caused by these MDRO carry significant morbidity and high mortality of up to 50%, however, there is no proven therapy for eradication of intestinal colonization of MDRO. There is accumulating evidence showing that the gut microbiota plays an important role in the control of intestinal colonization and infection by pathogenic bacteria. Administration of obligate anaerobic commensal bacteria to mice has been shown to markedly reduce VRE colonization. Preliminary evidence, mainly from anecdotal reports, have shown that fecal microbiota transplantation (FMT) in human carriers of MDRO were safe and potentially effective in eliminating intestinal colonization by various MDRO, including CRE and VRE, even in immunocompromised patients. Therefore, investigators hypothesize that FMT will be safe and potentially effective in eradicating intestinal colonization of CRE and VRE. This is a prospective pilot study to evaluate whether FMT is safe and effective to eradicate intestinal colonization of CRE and VRE.

NCT ID: NCT03388944 Completed - Sepsis Clinical Trials

PCT Guided Stopping of Antibiotic Therapy in Children With Sepsis

Start date: October 21, 2019
Phase: N/A
Study type: Interventional

The investigators' objective is to compare the risk of treatment failure* in children admitted to the pediatric intensive care unit (PICU) with sepsis and managed by procalcitonin guided therapy for stopping of antibiotics ('PCT- guided therapy' group) with those managed with standard practices based on the evidence based guidelines ('control' group). Children with suspected or proven sepsis will be randomized to the PCT guided group or the standard practices group and will be followed up for the outcome measures that include treatment failure and mortality. The investigators plan to enroll 560 patients over a period of 3 years. The investigators believe that the proposed study will provide the answer to reducing unnecessary antibiotic usage in the PICU without causing any harm to the patient in the form of treatment failure and/or mortality.

NCT ID: NCT02814877 Recruiting - Clinical trials for Antimicrobial Resistance

Efficacy and Cost-effectiveness of Hospital Antimicrobial Stewardship Programs

CEFECA
Start date: September 2016
Phase: N/A
Study type: Observational

The main objective of the project is to evaluate the efficiency and cost-effectiveness of different strategies aiming at optimizing antibiotic prescribing in hospitals. In the first section of the project, the project team intend to map the different antimicrobial stewardship programs in French hospital, by investigating a sample of 30 healthcare facilities, and determine the strategies to be evaluated by the model. The investigators will also evaluate physicians' adherence to the intervention to promote better use of antibiotics and explore potential barriers and facilitators to the implementation of effective strategies.