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Antimicrobial Resistance clinical trials

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NCT ID: NCT06358872 Not yet recruiting - Mortality Clinical Trials

Azithromycin for Child Survival in Niger II

AVENIR II
Start date: April 29, 2024
Phase: Phase 4
Study type: Interventional

Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years.

NCT ID: NCT06356285 Not yet recruiting - Clinical trials for Antimicrobial Resistance

Testing New Ways to Name Antimicrobial Resistance

Start date: April 10, 2024
Phase: N/A
Study type: Interventional

This study aims to investigate the public's views on antibiotics and the impact of different ways to name the potential consequences of antibiotics not working in the future. It is known that current ways to name this don't resonate well with the public, and the study team have worked with members of the public through focus groups and community workshops to develop new ways of describing this in a process of co-design. This study aims to test four different ways of presenting this potential crisis to the public, some of which are new communication strategies designed by the public themselves, to evaluate which are the most memorable and investigate the impact on behaviour change. Adults aged over 18, living in the United Kingdom, who have already signed up to a market panel research company will be eligible to participate in this study. Participants will be invited to complete a short online survey (this should take around five minutes), advertised to them by the market research panel they have already signed up to. This survey is completely anonymous, and contains some multiple-choice questions, and some that require a short free text response. At the start of the survey one of the four ways to name AMR will be presented to participants in the form of a poster. This study aims to result in an improved understanding regarding the general public's understanding of antibiotic use and investigate the impact of communication on behaviour change. The data from this study may be used to inform future public health campaigns on this topic and improve the use of antibiotics. This study will be conducted online using the Predictiv platform, an online platform built by the Behavioural Insights Team. The study is being run in collaboration between the Behavioural Insights Team and the Institute of Global Health Innovation at Imperial College London. Is it anticipated that the survey will open in April 2024 and be open until recruitment of 4000 participants is complete. This is expected to take 4-6 weeks.

NCT ID: NCT06305455 Not yet recruiting - Clinical trials for Antimicrobial Resistance

Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship

Start date: April 2024
Phase:
Study type: Observational

The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit.

NCT ID: NCT05960084 Not yet recruiting - Clinical trials for Antimicrobial Resistance

Impact of Reducing Colistin Use on Colistin Resistance in Humans and Poultry in Indonesia

COINCIDE
Start date: July 23, 2023
Phase:
Study type: Observational

Colistin (polymyxin E) is considered a last resort antimicrobial for treatment of infections with multidrug- resistant bacteria, classified by WHO as 'highest prioritized, critically important for human medicine'. WHO suggests to ban or highly restrict its use in animals. In Indonesia, colistin resistance in human Escherichia coli isolates is poorly characterized as it requires specific non-routine tests. Presence of colistin resistance in E. coli in poultry resulted in a ban for livestock in Indonesia in 2020. However, colistin is still suspected to be routinely used in humans in multiple settings but the reasons for these practices are poorly understood. The ban on colistin use in livestock offers a unique opportunity to assess the impact of this intervention on colistin resistance in humans and animals, and how a One Health perspective can strengthen this intervention. This project aims to: i) determine phenotypic and genotypic colistin resistance in E. coli from humans and poultry in Indonesia; ii) assess the impact of the colistin ban on resistance in E. coli in animals and humans; iii) estimate the transmission of colistin resistance between animals and humans; iv) study colistin use and perceptions at the community level; and v) expand the initial colistin ban in the animal production sector into an integrative multi-sectorial One Health intervention, which will be designed and implemented using a community participatory approach. This project will provide a strong scientific basis to AMR policies in Indonesia, with great significance across Southeast Asia.

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: NCT05734391 Completed - Clinical trials for Antimicrobial Resistance

Surveillance of Healthcare-associated Infections & Antimicrobial Resistance

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

The aims of this project, called "Surveillance of Healthcare-associated infections & Antimicrobial Resistance", or "SHARE", are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs to use data to prevent, detect, and contain emerging AMR threats; 3) deploy study teams to answer critical public health surveillance questions, and 4) to build a national network of infection prevention and control (IPC) resources to prevent, detect, and contain emerging infectious disease threats

NCT ID: NCT05451836 Completed - Clinical trials for Antimicrobial Resistance

N-of-1 Trials of Interventions to Improve Decision-making for Antibiotic Use

Start date: July 4, 2022
Phase: N/A
Study type: Interventional

Antibiotics have brought about a substantial reduction in infectious mortality. However, inappropriate antibiotic use has driven the rapid increase in antibiotic resistance. The Centers for Disease Control and Prevention estimates that at least 2 million people in the United States (US) become infected with antibiotic-resistant bacteria each year, and at least 23,000 people die each year as a direct result of these infections. Antimicrobial stewardship programs have largely focused on inpatient settings and have excluded emergency departments (ED). The ED is a unique healthcare setting which is distinct from inpatient and other ambulatory settings. Given the many factors that could influence inappropriate antibiotic prescribing, a one-size-fits-all approach is unlikely to work for all physicians and all regions. Hence, the design and implementation of tailored interventions based on the understanding of the local patient, physician, and ED organizational factors are pertinent for the interventions. The team has conducted a mixed-methods study to understand the patient, physician, and organisational factors that influence antibiotic prescribing in the local EDs. The findings of the study were used to design two interventions which will be implemented in four EDs in Singapore to reduce the inappropriate antibiotic prescribing in the ED. This study aims to evaluate the effectiveness of 2 tailored antimicrobial stewardship interventions in reducing antibiotic prescribing rates for uncomplicated URTI patients attending four adult EDs in Singapore: 1. Patient education via information leaflets addressing knowledge-, perception-, and belief-gaps of the local patient population on antibiotic use for URTI 2. Two-monthly physician feedback on their antibiotic prescribing rates by senior ED doctors coupled with bite-sized information on good antibiotic prescribing practices. The study will include an initial control period of 18 months where none of the 4 hospitals will be exposed to the interventions. At the beginning of the intervention period, the 4 hospitals will be randomly assigned to one of the 2 interventions (Patient education or physician feedback). At the end of 6 months, all hospitals will receive the other intervention and be exposed to both interventions concurrently. Data will be collected for another 6 months to assess if the effects of the interventions are persistent.

NCT ID: NCT05445414 Completed - Clinical trials for Antimicrobial Resistance

A Mobile App Serious Game to Increase Awareness of Antibiotic Use in the Community

Start date: January 4, 2022
Phase: N/A
Study type: Interventional

The widespread and unnecessary use of antibiotics has encouraged the growth of antibiotic-resistant bacteria which can cause hard-to-treat and deadly infections. These infections are due to antimicrobial resistance (AMR). The public's lack of knowledge on the indication for and proper use of antibiotics often leads to unnecessary patient demands and subsequent misuse of antibiotics. Traditional mass public educational efforts through the use of brochures, posters and advertisements are extensive in outreach but questionable in effectiveness in improving the general public's knowledge on appropriate antibiotics use and AMR. Serious games app provides an additional venue for public education outreach to the population since a substantial amount of time is spent using smartphones. The use of serious games is expected to increase user engagement in learning, which will lead to short- and long-term improvements in knowledge, attitudes and perceptions on the appropriate use of antibiotics. The study team has co-developed an evidence-based serious game app- "SteWARdS Antibiotic Defense" -with Temasek Polytechnic. Users will be brought on a quest to learn about antibiotic use and AMR through mini-games and the bite-sized information released throughout the game quest. We intend to clinically validate our evidence-based app and improve its application with actual participants' feedback on its usage. Hence, this study aims to evaluate the effectiveness of an evidence-based serious game mobile application (SteWARdS Antibiotic Defense) in improving the knowledge on, attitude towards, and perception (KAP) of appropriate antibiotic use and AMR among Singaporeans. The primary objective is to assess the change in knowledge on antibiotic use and AMR among the app users compared with the control group. The secondary objectives are to:1) Assess the extent of user engagement of the app by evaluating the users' average screen time per day; and 2) Assess the level of user satisfaction in using the app for learning through a user satisfaction survey.

NCT ID: NCT05296837 Recruiting - Clinical trials for Antimicrobial Resistance

Ocular Rosacea Biome Study

ORBS
Start date: June 22, 2023
Phase: Phase 4
Study type: Interventional

Ocular rosacea is an inflammatory disease of the eyelids and ocular surface. Like the facial disease, the ocular condition is chronic and recurrent. Sequelae of ocular rosacea vary from mild to severe. Ocular rosacea may cause chronic eye redness, blepharitis, recurrent chalazia, dry eye, corneal erosion, corneal vascularization, and corneal ulceration. Rosacea affecting the cornea can result in vision loss. Prescription eye drops and ointments can be used topically to control mild ocular rosacea. However, severe disease, or rosacea that is not well controlled with local treatments is treated systemically. The most commonly used systemic treatment for rosacea is the bacteriostatic antibiotic doxycycline. Rosacea treatment doses of doxycycline vary widely. Treatment-dose doxycycline for systemic infections is 100mg twice a day. However, as rosacea is considered an inflammatory disease, doxycycline is often dosed at what is termed, sub-microbial dose doxycycline (SDD). Initially introduced in the oral medicine literature, SDD are doses 40mg and lower because systemic administration at this dose does not appear to alter the oral mucosa flora or increase resistance rates when given long-term for periodontal disease. Whereas 100mg doxycycline, even when given short term, may increase the percentage of culturable nasopharyngeal flora that is resistant to doxycycline. The FDA does not categorize SDD an antibiotic, stating this dosing is expected to exhibit only anti-inflammatory activity.

NCT ID: NCT05285657 Recruiting - 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.