Bacterial Infections Clinical Trial
Official title:
Quasi-experimental Intervention Study to Optimize the Use of New Antibiotics (Project NEW_SAFE)
Quasi-experimental intervention multicenter trial of patients treated with new antibiotics
(before-after study).
The study will be carried out in 14 hospitals of the Andalusian Public Health System with
representation from all the provinces and has been designed in two phases:
1. A first phase in which an observational study of historical preintervention cohorts of
patients who have received either empirical or targeted treatment with ceftaroline,
tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam and isavuconazole
from January 2016 to December 2019 will be developed. Case detection will be carried out
by locating the antimicrobial prescriptions in the electronic prescribing systems and /
or pharmaceutical management systems of each hospital. A set of epidemiological,
clinical, microbiological and prognostic variables will be completed in each case.
2. A second phase or intervention period that will be applied to the cohort of patients
treated with new antibiotics (intervention cohort) from January 2020 to June 2021. A
quasi-experimental intervention study will be carried out through the development of a
Program for Optimizing the use of Antibiotics (PROA) in Spanish, Antimicrobial
Stewardship Program (ASP) in English, in the participating hospitals. It will consist in
the development of a consensus document on the use of new antibiotics following a Delphi
methodology, dissemination of the consensus document / guide among the participating
hospitals and audit on the prescription of new antimicrobials after the implementation
of the guide based on providing non-imposition advice and positive reinforcement to the
prescriber. The recommendations will be consigned in a structured form, which will allow
to evaluate the degree of follow-up of the recommendations. The audit will be performed
on day 0-1 of the prescription.
3. Cohort of bacteremia due to multiresistant microorganisms ("safety" cohort): In order to
evaluate the safety of the use of new antimicrobials against therapeutic alternatives in
syndromes where they are potentially a preferred option and parallel to the two phases,
episodes for bacteremia by carbapenem-resistant Acinetobacter baumannii and Pseudomonas
aeruginosa, carbapenem-resistant enterobacteria, vancomycin-resistant Enterococcus
faecium and methicillin-resistant Staphylococcus aureus occurred in participating
hospitals from 2017 to 2021 will be collected.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03726216 -
Xydalba Utilization Registry in France
|
||
| Completed |
NCT03605498 -
OR PathTrac (Tracking Intra-operative Bacterial Transmission)
|
||
| Withdrawn |
NCT05269121 -
Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
|
Phase 1/Phase 2 | |
| Completed |
NCT02541695 -
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
|
N/A | |
| Recruiting |
NCT02074865 -
Children's Antibiotic Resistant Infections in Low Income Countries
|
N/A | |
| Completed |
NCT01932034 -
Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software
|
N/A | |
| Completed |
NCT01689207 -
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)
|
Phase 1 | |
| Completed |
NCT01412801 -
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
|
Phase 2 | |
| Not yet recruiting |
NCT01159470 -
The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children
|
N/A | |
| Completed |
NCT00983255 -
Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)
|
Phase 1 | |
| Completed |
NCT00678106 -
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
|
Phase 1 | |
| Completed |
NCT00799591 -
French Study In ICU Patients Treated With Tigecycline
|
N/A | |
| Completed |
NCT01074775 -
Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection
|
N/A | |
| Completed |
NCT00478855 -
Tazocin Intervention Study
|
Phase 4 | |
| Terminated |
NCT00431028 -
Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT03634904 -
Serum Ceftazidime Concentrations in Hemodialysis Patients
|
N/A | |
| Recruiting |
NCT05684705 -
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100
|
Phase 1 | |
| Recruiting |
NCT03858387 -
PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
|
||
| Enrolling by invitation |
NCT04764058 -
Efficacy and Safety of Colistin Based Antibiotic Therapy
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06319235 -
Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
|
Phase 1/Phase 2 |