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Short-course aminoglycosides as adjunctive treatment in adults with sepsis

Short-course aminoglycosides as adjunctive treatment in adults with sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29602
Enrollment
3140
Registered
2021-04-23
Start date
2021-06-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Sepsis

Interventions

Ceftriaxon monotherapy vs cefuroxime with short-course aminoglycoside (gentamicin or tobramycin)

Sponsors

University Medical Center Utrecht
Lead Sponsor

Eligibility

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) or Modified Early Warning Score (MEWS) = 5. 5) Requiring intravenous antibiotic treatment and hospitalization.

Exclusion criteria

Exclusion criteria: 1) Working diagnosis at the ER of pneumonia. 2) Chemotherapy induced neutropenia as this is considered a separate entity in the guidelines. 3) Pre-existing renal failure defined as a GFR < 30, due to a relative contra-indication for aminoglycosides. 4) Allergy for cephalosporins or aminoglycosides, known prior to the start of treatment. 5) Indication for empirical coverage of ESBL-producing gram-negative bacteria according to the Dutch sepsis guidelines, i.e. known colonization or infection with ESBL-producing gram-negative bacteria in the prior year.

Design outcomes

Primary

MeasureTime frame
30-day all-cause mortality

Secondary

MeasureTime frame
Secondary outcomes include duration of IC and hospital admission, quality of life, nephrotoxicity, ototoxicity and costs. In a cost-effectiveness analysis we will determine the costs per quality-adjusted life year gained.

Contacts

Public ContactSharon van den Eijnde

UMC Utrecht

sagastudie@umcutrecht.nlsagastudie@umcutrecht.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)