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Investigation of unusually rapid clearance of cefazolin

Investigation of hyper-excretion of cefazolin as a potential cause of treatment failure in patients with invasive bacterial infection

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000332527
Enrollment
10
Registered
2024-03-26
Start date
2024-06-03
Completion date
2025-06-02
Last updated
2024-04-01

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

Conditions

None listed

Brief summary

This study aims to determine whether patients treated with cefazolin who have incidentally been found to have very low plasma cefazolin concentrations in the course of standard clinical management of invasive bacterial infections have abnormally rapid clearance of this drug. After recovery, these opportunistically-identified patients will be administered a 1g dose of cefazolin and will then have multiple free plasma concentration measurements in the 8 hours post-dose. These data will be used to construct pharmacokinetic curves which will then be compared with known drug pharmacokinetics in normal individuals. Patients will be asked to provide written informed consent prior to enrolment in the study.

Interventions

Administration of a single intravenous dose of 1g of cefazolin over 3-5 minutes

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Abnormally low plasma cefazolin concentration despite standard dosing and/or cefazolin treatment failure not easily explained by an alternative cause Age greater than or equal to 18 years Resolution of index infection Provision of informed consent to participate in the study Able to comply with study procedures

Exclusion criteria

Prior adverse reaction to cefazolin or any of its excipients Poor venous access Most recent haemoglobin concentration below 110g/L for women or 115g/L for men Receipt of cefazolin within the last 7 days

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026