Short-course aminoglycosides as adjunctive treatment in adults with sepsis

Short-course aminoglycosides as adjunctive treatment in adults with sepsis - SAGA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53650

Enrollment

3140

Registered

2022-03-24

Start date

2022-05-25

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infection sepsis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Age >= 18 years 2) Presenting to the ER 3) Suspicion of bacterial infection of unknown origin, primary suspected urinary origin or primary suspected abdominal origin. 4) National Early Warning Score (NEWS) >= 5. 5) Requiring intravenous antibiotic treatment and hospitalization.

Exclusion criteria

Exclusion criteria: 1) Working diagnosis at the ED of pneumonia (even if other foci are mentioned in the differential diagnosis). 2) Chemotherapy induced neutropenia as this is considered a separate entity in the guidelines. 3) History of renal transplantation or pre-existing renal failure defined as a GFR

Design outcomes

Primary

Measure	Time frame
30-day all-cause mortality	—

Secondary

Measure	Time frame
Main study: • Duration of intravenous antibiotic treatment in calendar days and hours • Time to switch to oral treatment in calendar days and hours • Duration of hospitalization in calendar days • ICU admission, length of ICU stay, mechanical ventilation • ICU admission in patients who are not directly admitted to the ICU • Complications during hospital admission possibly related to the disease or treatment. • Nephrotoxicity requiring dialysis • Hospital re-admission within 30 days of initial hospitalization • Failure of treatment Active Follow-up subset: • Quality of life • 1 year mortality • Duration of absenteeism • Health care cost per quality-adjusted life year • Societal costs per quality-adjusted life year • Nephrotoxicity according to the The Kidney Disease: Improving Global Outcomes (KDIGO) criteria. For criteria see chapter 7.2.1. • Recovery of renal function in patients with acute renal failure. • Subjective hearing loss PKPD subset: - To define the association between attained PK/PD index of empirical sepsis treatment with cefuroxime, ceftriaxone, gentamicin and/or tobramycin in the first 48 hours of treatment and 30-day mortality and other clinical outcomes such as renal toxicity and length of hospital stay in patients with community-onset sepsis - To define population pharmacokinetic characteristics of cefuroxime, ceftriaxone, gentamicin and tobramycin in patients with community-onset sepsis, including risk factors for not reaching the PK/PD target, in order to design future trials on optimized empirical antibiotic dosing in sepsis - To assess and compare attained PK/PD indices of patients sepsis empirically treated with cefuroxime plus aminoglycoside versus ceftriaxone or cefuroxime monotherapy and their association with 30-day mortality. - To assess and compare attained PK/PD indices of patients empirically treated with gentamicin versus tobramycin and their association with 30-day mortality.	—

Measure

Time frame

Main study: • Duration of intravenous antibiotic treatment in calendar days and hours • Time to switch to oral treatment in calendar days and hours • Duration of hospitalization in calendar days • ICU admission, length of ICU stay, mechanical ventilation • ICU admission in patients who are not directly admitted to the ICU • Complications during hospital admission possibly related to the disease or treatment. • Nephrotoxicity requiring dialysis • Hospital re-admission within 30 days of initial hospitalization • Failure of treatment Active Follow-up subset: • Quality of life • 1 year mortality • Duration of absenteeism • Health care cost per quality-adjusted life year • Societal costs per quality-adjusted life year • Nephrotoxicity according to the The Kidney Disease: Improving Global Outcomes (KDIGO) criteria. For criteria see chapter 7.2.1. • Recovery of renal function in patients with acute renal failure. • Subjective hearing loss PKPD subset: - To define the association between attained PK/PD index of empirical sepsis treatment with cefuroxime, ceftriaxone, gentamicin and/or tobramycin in the first 48 hours of treatment and 30-day mortality and other clinical outcomes such as renal toxicity and length of hospital stay in patients with community-onset sepsis - To define population pharmacokinetic characteristics of cefuroxime, ceftriaxone, gentamicin and tobramycin in patients with community-onset sepsis, including risk factors for not reaching the PK/PD target, in order to design future trials on optimized empirical antibiotic dosing in sepsis - To assess and compare attained PK/PD indices of patients sepsis empirically treated with cefuroxime plus aminoglycoside versus ceftriaxone or cefuroxime monotherapy and their association with 30-day mortality. - To assess and compare attained PK/PD indices of patients empirically treated with gentamicin versus tobramycin and their association with 30-day mortality.

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Countries

Netherlands

Outcome results