NCT05048693

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

September 8, 2021

Last Update Submit

June 17, 2024

Conditions

Multi-antibiotic Resistance

Keywords

Multidrug-resistant Gram-negative bacteriaAntibiotic resistanceCefiderocolCeftazidime-avibactamCeftolozane-tazobactamFosfomycinMeropenem-vaborbactamImipenem-relebactam

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (16)

  • Severity of illness

    30 days from enrollment

  • Indication for treatment

    30 days from enrollment

  • Use of antibiotic combination therapy

    30 days from enrollment

  • Microbiological results

    30 days from enrollment

  • Treatment failure

    30 days from enrollment

  • +11 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in seven University Hospitals in Sweden treated with any of the following antibiotics; cefiderocol, ceftazidim-avibactam, ceftolozan-tazobactam, fosfomycin, meropenem-vaborbactam or imipepenem-relebactam against an acute infection.

You may qualify if:

  • Treatment with any of the following antibiotics; cefiderocol, ceftazidim-avibactam, ceftolozan-tazobactam, fosfomycin, meropenem-vaborbactam or imipepenem-relebactam against an acute infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Skåne University Hospital

Lund, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Umeå University Hospital

Umeå, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Study Officials

  • Thomas Tängdén, MD, Phd

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 17, 2021

Study Start

November 1, 2021

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations

SE(7)