Clinical trials: AMR
Antimicrobial Resistance (AMR)
A Digital Escape Room to Teach Medical Students About Antimicrobial Resistance Using the One Health Approach
The goal of this clinical trial is to evaluate the effectiveness of a One Health-based educational intervention in final-year medical students from two universities in Norway and Zambia. The main question it aims to answer is: 1.
- Trial name
- NCT07848217
- Testing
- AMRageddon
- Where
- 2 sites in Norway, Zambia
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Norwegian University of Science and Technology
Antimicrobial Stewardship, Antimicrobial Resistance (AMR)
A Digital Escape Room to Teach Veterinary Students About Antimicrobial Resistance Using the One Health Approach
The goal of this study is to evaluate the effectiveness of a One Health-based educational intervention in second-year medical students from the veterinary university in Norway The main question it aims to answer is: 1.
- Trial name
- NCT07864077
- Testing
- AMRageddon
- Where
- Norway
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Norwegian University of Science and Technology
Antibody-Mediated Rejection (AMR)
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure.
- Trial name
- NCT07613359
- Testing
- Mezagitamab
- Where
- 35 sites in United States, China and 3 more
- Volunteers
- 36 people
- Sponsor
- Takeda
Sepsis, Antimicrobial Resistance (AMR)
Implementation of a Sepsis Chart and Its Effects on Mortality Rate in Indonesian Primary Referral Hospitals
The goal of this observational study is to evaluate the effectiveness of implementing Koran Sepsis, or sepsis chart, a paper-based order set designed to guide the implementation of the One-hour Sepsis Bundle, in improving…
- Trial name
- NCT07843277
- Testing
- Sepsis chart (koran sepsis), Usual care
- Where
- 2 sites in Indonesia
- Volunteers
- 304 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Sepsis, Antimicrobial Resistance (AMR)
Molecular-based Optimization of Pathogen Identification in Sepsis Patients in the Indonesian National Referral Hospital
This study aims to compare the diagnostic performance of conventional blood culture with two molecular-based diagnostic approaches, Hybrispot DNA Flow and metagenomic next-generation sequencing (mNGS), for the identification of…
- Trial name
- INA-MOSAIC (NCT07841535)
- Testing
- Standard-of-care blood culture, Hybrispot DNA Flow, Metagenomic 16s RNA
- Where
- Indonesia
- Volunteers
- 415 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Antimicrobial Resistance (AMR), ESBL
One Health Determinants of Rectal Colonization by ESBL-Producing Enterobacterales in the Community
This multicenter cross-sectional observational study aims to determine the prevalence of rectal colonization by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales among community-dwelling adults in Argentina and…
- Conditions
- Antimicrobial Resistance (AMR), ESBL, Gut Microbiota Dysbiosis, Environmental Exposure
- Trial name
- NCT07818109
- Where
- Argentina
- Volunteers
- 432 people, healthy volunteers welcome
- Sponsor
- Hospital Italiano de Buenos Aires
Multidrug-Resistant Organism Infection, Healthcare-Associated Infections (HAIs)
Prevalence of Multidrug-Resistant Organism Infections in General Adult Wards in Argentina (PREV-AR 2 - IGA)
This study measures how common infections caused by multidrug-resistant organisms (MDROs) are among adult patients hospitalized in general medical and surgical wards in Argentina, and how these infections relate to in-hospital…
- Conditions
- Multidrug-Resistant Organism Infection, Healthcare-Associated Infections (HAIs), Antimicrobial Resistance (AMR)
- Trial name
- PREVAR 2-IGA (NCT07797569)
- Testing
- Observational data collection (chart review / point-prevalence survey)
- Where
- Argentina
- Volunteers
- 2,000 people
- Sponsor
- Hospital Italiano de Buenos Aires
Antibody-Mediated Rejection, Kidney Transplantation
Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.
- Conditions
- Antibody-Mediated Rejection, Kidney Transplantation, Biopsy-proven Histologic Scores, AMR
- Trial name
- CONCORD (NCT06744647)
- Testing
- ALXN2030
- Where
- 51 sites in United States, Brazil and 6 more
- Volunteers
- 47 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthcare-Associated Infections (HAIs), Carbapenem-Resistant Enterobacteriaceae Colonization
Correlation Between Carbapenemase-Producing Enterobacterales Load, Environmental Contamination, and Transmission in Critical Care Units
Carbapenemase-producing Enterobacterales (CPE) are multidrug-resistant bacteria that can colonize the gastrointestinal tract of hospitalized patients and spread within intensive care units (ICUs).
- Conditions
- Healthcare-Associated Infections (HAIs), Carbapenem-Resistant Enterobacteriaceae Colonization, Antimicrobial Resistance (AMR)
- Trial name
- CPE-Load ICU S (NCT07685132)
- Where
- Argentina
- Volunteers
- 60 people
- Sponsor
- Hospital Italiano de Buenos Aires
Gram Negative Infections, Antimicrobial Resistance (AMR)
PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE
A multicenter international prospective observational pharmacological study in adult patients (≥18 years) treated with ceftazidime/avibactam (CAZ/AVI) alone or with CAZ/AVI plus fosfomycin (FOS) for infection due to…
- Trial name
- CAVIFOS (NCT06717594)
- Where
- 2 sites in Italy, Spain
- Volunteers
- 60 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Antimicrobial Resistance (AMR), Oral Microbiota
Salivary Microbiota and Antimicrobial Resistance in Relation to Chlorhexidine Use
This study evaluated the ecological effects of 0.06% chlorhexidine toothpaste on the salivary microbiota of healthy individuals, focusing on taxonomic composition, functional shifts, and prevalence of predicted antimicrobial…
- Conditions
- Antimicrobial Resistance (AMR), Oral Microbiota, Oral Microbiome Health, Chlorhexidine
- Trial name
- SMARCH (NCT07570927)
- Testing
- 0.06% Chlorhexidine Digluconate Toothpaste
- Where
- 2 sites in Czechia
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Masaryk University
Antimicrobial Prescribing Practices, Antimicrobial Resistance (AMR)
Development and Implementation of Mobile Antibiograms to Optimize Empirical Antibiotic Prescriptions Among Prescribers in Tertiary Hospitals in Tanzania
Antimicrobial resistance (AMR) is a critical issue, especially in Africa, with resistance to common antibiotics reaching 100% in some areas.
- Trial name
- AMR; AMU; DDD (NCT07393308)
- Testing
- Mobile antibiogram application, standard of care
- Where
- 2 sites in Tanzania
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Muhimbili University of Health and Allied Sciences
Respiratory Tract Infection Bacterial, Respiratory Tract Infection Viral
CRP and Patient Information Leaflets to Optimise Antibiotic Treatments for Adults With Respiratory Tract Infections in Primary Care in Kyrgyzstan
This study aims to determine how CRP levels and Patient Information Leaflets (PILs) affect antibiotic prescribing in adults with acute respiratory symptoms in Kyrgyz primary care.
- Conditions
- Respiratory Tract Infection Bacterial, Respiratory Tract Infection Viral, AMR, CRP
- Trial name
- 2CARE INSTALL (NCT07261969)
- Testing
- The C-reactive protein point-of-care test (CRP-POCT), Patient information leaflets
- Where
- 2 sites in Kyrgyzstan
- Volunteers
- 1,050 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
UTI - Urinary Tract Infection, UTI - Lower Urinary Tract Infection
Clinical Impact Analysis of PA-100 AST in a Spanish GP Setting
Assessment of workflow implications of the PA-100 AST System. Using well-defined data collection protocols, the study comprises the following: Collection of clean-catch midstream urine samples Measurement of specimens on the…
- Conditions
- UTI - Urinary Tract Infection, UTI - Lower Urinary Tract Infection, AMR, Cystitis Acute
- Trial name
- NCT07189429
- Testing
- PA-100 AST
- Where
- Spain
- Volunteers
- 199 people
- Sponsor
- Sysmex Europe GmbH
Penicillin Allergy, Antimicrobial Drug Resistance
A Study of the Impact of Penicillin Allergy on Antimicrobial Resistance and ouTcomes
Penicillin allergy is one of the commonest reported allergies. The presence of a penicillin allergy record in a patients notes leads to the avoidance of recommended first-line penicillin antibiotics and the use of alternative…
- Conditions
- Penicillin Allergy, Antimicrobial Drug Resistance, AMR
- Trial name
- IMPAART (NCT07177690)
- Where
- United Kingdom
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- University of Leeds
Rotavirus Gastroenteritis, Rotavirus Vaccines
ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage
Rotavirus is the most common aetiology of serious diarrhoea in young children. Despite antibiotics not being indicated in its treatment, diarrhoea remains a very common cause for antibiotic prescribing in low-income settings.
- Conditions
- Rotavirus Gastroenteritis, Rotavirus Vaccines, Antimicrobial Resistance (AMR), Antibiotic
- Trial name
- NCT06882070
- Testing
- Vaccine
- Where
- 2 sites in Ghana, Zambia
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Antimicrobial Resistance (AMR)
NCCR AntiResist:: New Approaches to Combat Antibiotic-resistant Bacteria
This is an explorative, mono-center study including prospectively collected patient samples from the University Hospital of Basel.
- Trial name
- AntiResist (NCT05017766)
- Testing
- analysis of antimicrobial resistance
- Where
- Switzerland
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Sepsis, Septic Shock
PCT Guided Stopping of Antibiotic Therapy in Children With Sepsis
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…
- Conditions
- Sepsis, Septic Shock, Antibiotic Use, Procalcitonin
- Trial name
- NCT03388944
- Testing
- PCT group
- Where
- 2 sites in India
- Volunteers
- 561 people
- Sponsor
- All India Institute of Medical Sciences
Gram Negative Infection, Antimicrobial Resistance (AMR)
PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections
A multicenter, national, prospective, observational pharmacological study of patients with difficult-to-treat Gram-negative infections treated with ceftazidime/avibactam (CAZ/AVI) or cefiderocol (CEF) monotherapy or combination…
- Trial name
- PACCOF (NCT06651047)
- Where
- 11 sites in Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Bologna
Acute Antibody-Mediated Rejection (AMR)
A Multicenter Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Participants With Kidney Transplant
The main purpose of the study is to evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free immunoglobulin (IVIg) for the treatment of acute…
- Trial name
- NCT02547220
- Testing
- Cinryze®
- Where
- 47 sites in United States, Canada and 4 more
- Volunteers
- 39 people
- Sponsor
- Shire