Masking of an intravenous preparation of ceftriaxone for use in clinical trials: a technical report

Intravenous antibiotics are often evaluated in clinical trials in hospitalised patients but for blinded trials masking of antibiotics is required. To evaluate the effectiveness of masking of ceftriaxone and amoxicillin / clavulanic acid for use in blinded clinical trials. Amoxicillin / clavulanic ac...

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Bibliographic Details
Published in:Critical care and resuscitation 2023-12, Vol.25 (4), p.172-174
Main Authors: Golding, David M., Chan, Tak Wai, Orozov, Nikola G., Young, Paul J.
Format: Article
Language:English
Subjects:
antibiotic
blinding
clinical trials
masking
Original
performance bias
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Summary:Intravenous antibiotics are often evaluated in clinical trials in hospitalised patients but for blinded trials masking of antibiotics is required. To evaluate the effectiveness of masking of ceftriaxone and amoxicillin / clavulanic acid for use in blinded clinical trials. Amoxicillin / clavulanic acid (1.2g) and ceftriaxone (1g and 2g) were diluted in 100mL of sodium chloride. Clinicians from a single centre were asked to attempt to distinguish solutions containing antibiotics from solutions without added antibiotics at time points up to 12 hours following dilution. 1g of ceftriaxone diluted in 100 mL of 0.9 sodium chloride stored in a light-protected bag and refrigerated at 3-4 °C for up to 10 h could not readily be distinguished from 100 mL of 0.9 % sodium chloride. However, solutions containing either amoxicillin / clavulanic acid (1.2g) or ceftriaxone (2g) were readily identifiable. 1 g of ceftriaxone can be effectively masked by dilution in 100mL of sodium chloride.
ISSN:1441-2772
2652-9335
DOI:10.1016/j.ccrj.2023.10.002