Standard vs. Double Dosing of Beta-lactam Antibiotics in Critically Ill Sepsis Patients

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The BULLSEYE trial is a randomized controlled study designed to enhance the treatment of critically ill patients with septic shock.

The concept of administering higher and double doses of beta-lactams in such patients has got increasing attention over the past few years.

To our knowledge, this study is the first prospective trial investigating a short term higher dosing regimen.

Higher dosing naturally comes with an increased risk of toxicity. However, no additional toxicity was observed with increased dosages in the DOLPHIN study.

Furthermore, a survey was carried out in our international consortium (including investigators from Belgium, France, and Australia).

All collaborators agreed that double dosing during a short period (of 48 h) would lead to improved target attainment and would outbalance the possible risk of toxicity for all antibiotics.

Furthermore, a Data Safety Monitoring Board (DSMB) has been established to offer objective advice on the safety and efficacy of the trial during interim analyses and annual meetings.

It should be noted however, that in a critically ill patient it is very challenging to differentiate between adverse effects of study medication, other administered medications or the medical condition itself.

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