Multi-antibiotic Resistance Clinical Trial
Official title:
Use of New Antibiotics Against Multidrug-resistant Gram-negative Bacteria in Swedish University Hospitals
Antibiotic resistance is a growing global health problem of great concern, especially multidrug-resistant Gram-negative bacteria. In recent years some new antibiotics targeting these bacteria have been developed. The aim of this study is to investigate how these new antibiotics are used in Sweden. Information will be collected on patients, types of infections, dosing strategies, treatment outcome and occurrence of antibiotic resistance during treatment. The overall goal is to increase the knowledge about how these antibiotics are prescribed and how to optimize the use of them in clinical practice.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Treatment with any of the following antibiotics; cefiderocol, ceftazidim-avibactam, ceftolozan-tazobactam, fosfomycin, meropenem-vaborbactam or imipepenem-relebactam against an acute infection. Exclusion Criteria: - Ongoing treatment with any of the above mentioned antibiotics for more than seven days at the point of inclusion. |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Gothenburg | |
Sweden | Linköping University Hospital | Linköping | |
Sweden | Skåne University Hospital | Lund | |
Sweden | Örebro University Hospital | Örebro | |
Sweden | Karolinska University Hospital | Stockholm | |
Sweden | Umeå University Hospital | Umeå | |
Sweden | Uppsala University Hospital | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Uppsala University | Karolinska University Hospital, Örebro University, Sweden, Sahlgrenska University Hospital, Sweden, Skane University Hospital, University Hospital, Linkoeping, University Hospital, Umeå |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical cure | Defined as discontinuation of the study drug following clinical or laboratory improvement with regard to the treated infection. Information on this will be extracted from the electronical medical records. | 30 days from enrollment | |
Primary | Microbiological cure | Defined as negative follow-up clinical cultures sampled seven days from start of treatment with the study drug. Information on this will be extracted from the electronical medical records. | 30 days from enrollment | |
Primary | All-cause mortality | Defined as death within 30 days from start of treatment with the study drug. Information on this will be extracted from the electronical medical records. | 30 days from enrollment | |
Secondary | Severity of illness | The severity of illness will be assessed with Sequential Organ Failure Assessment (SOFA) Score, which is a scoring system used in the assessment of acute morbidity in a range of critical illnesses. The SOFA-score allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulation, liver, cardiovascular, renal, and neurologic) and assigns a score based on the data obtained in each category. The higher the SOFA score, the higher the likely mortality. The requested information to calculate the score for each participant will be obtained from the electronical medical records. | 30 days from enrollment | |
Secondary | Indication for treatment | The type of infection will be obtained from the electronical medical records. The clinical assessment of infection type will be based on clinical symptoms and the sample site of cultures where the infecting bacteria was identified (e.g., blood, wound, nasopharynx, urine). | 30 days from enrollment | |
Secondary | Use of antibiotic combination therapy | Information on any concomitant antibiotic treatment used in combination with the study drug will be obtained from the electronical medical records. | 30 days from enrollment | |
Secondary | Microbiological results | Results from routine microbiological analyses (bacterial species, antibiotic susceptibility) of infecting bacteria will be obtained from the electronical medical records. | 30 days from enrollment | |
Secondary | Treatment failure | Defined as change of antibiotic treatment against infecting bacteria because of treatment failure with the study drug as documented by the treating physician. Information on this will be extracted from the electronical medical records. | 30 days from enrollment | |
Secondary | Colonization with multidrug-resistant Gram-negative bacteria in feces | Screening of multidrug-resistant Gram-negative bacteria in fecal samples will be performed seven days after start of treatment with the study drug to detect emergence of antibiotic resistance in the intestinal microbiota. Information on screening results will be obtained from the electronical medical records. | 30 days from enrollment | |
Secondary | Mortality attributable to infection | Defined as death within 30 days from start of treatment with the study drug where the cause of mortality is determined to be the infection treated with the study drug, as documented by the treating physician. Information on this will be extracted from the electronical medical records. | 30 days from enrollment | |
Secondary | Readmissions within 30 days | Information on readmissions within 30 days from start of treatment with the study drug will be obtained from the electronical medical records. | 30 days from enrollment | |
Secondary | Documented side effects | Information on suspected side effects associated with treatment with the study drug will be obtained from the electronical medical records. | 30 days from enrollment | |
Secondary | Occurrence of Clostridioides difficile infection | Information on confirmed Clostridioides difficile infection within 30 days from start of treatment with the study drug will be obtained from the electronical medical records. | 30 days from enrollment | |
Secondary | Duration of hospitalization | Information on number of hospital days will be obtained from the electronical medical records. | 1 year from enrollment | |
Secondary | Use of study drug in relation to the approved indications | Indication for the prescribed study drug (secondary outcome measure no. 2) will be compared to the approved indications for the respective study drug according to the summary of product characteristics (SPC). | 1 year from enrollment | |
Secondary | Dosing of study drug in relation to recommendations | Dosing of the study drug, extracted from the electronical medical records, will be compared to the approved dosing according to the summary of product characteristics (SPC). | 1 year from enrollment | |
Secondary | Phenotypic characterization of isolated bacteria | Isolated bacteria will be collected from the local microbiological laboratories for minimum inhibitory concentration (MIC) determination with phenotypical methods (e.g., microdilution, agar dilution) at the reference laboratory at Uppsala University. | 1 year from enrollment | |
Secondary | Genotypic characterization of isolated bacteria | Isolated bacteria will be collected from the local microbiological laboratories for genotypic characterization by whole-genome sequencing to determine the presence of resistance genes and mutations (e.g., production of beta-lactamases, porin loss and efflux) at the reference laboratory at Uppsala University. | 1 year from enrollment | |
Secondary | Emergence of antibiotic resistance | In case of repeated growth of the same bacterial species in clinical or screening samples seven days from start of treatment, the two isolates (prior and post treatment start with study drug) will be compared by MIC determination and whole-genome sequencing at the reference laboratory at Uppsala University regarding resistance genes and mutations to detect resistance development during treatment. | 2 years from enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03309358 -
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
|
Phase 1 | |
Completed |
NCT02909946 -
Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents
|
N/A | |
Recruiting |
NCT04335383 -
Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies
|
||
Recruiting |
NCT04181112 -
Fecal Transplant for MDRO Decolonization
|
N/A | |
Completed |
NCT05897801 -
Distinguishing Bacterial and Viral Infections by MeMed BV® Test to Limit Gut Colonization by MDRO
|
||
Completed |
NCT04212130 -
Can Environmental Cleanliness be Assessed by BCA (Bicinchoninic Acid) Method
|
N/A | |
Completed |
NCT05100407 -
Factors Impacting the Prevalence of MDR Bacteria
|
||
Completed |
NCT05549427 -
Ventilator Associated Pneumonia by Multi-Drug Resistant Organism
|
||
Not yet recruiting |
NCT06370299 -
Screening of Multidrug Resistant Bacteria, and the Clinical Implication for the Patient
|
||
Recruiting |
NCT06148480 -
Perinatal Transmission of MDR Bacteria
|
||
Recruiting |
NCT04995133 -
Colistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs.
|
Phase 4 | |
Recruiting |
NCT03921645 -
Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
|
N/A | |
Completed |
NCT06199141 -
Multi-drug Resistant Gram-negative Bacteria and Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
|
||
Recruiting |
NCT04759001 -
FMT for the Decolonization of Carbapenem-resistant Enterobacteriaceae
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05791396 -
FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae
|
Phase 1/Phase 2 | |
Terminated |
NCT02906774 -
Fecal Transplant for MDR Pathogen Decolonization
|
||
Recruiting |
NCT06036628 -
Resistant Bacteria in Children in France
|