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Table 4 Description of a randomized clinical trial that should be performed to investigate CI vs. IB beta-lactam antibiotics

From: Continuous beta-lactam infusion in critically ill patients: the clinical evidence

Criteria Comments
Population Should only include patients with sepsis or severe sepsis
Intervention Antibiotic dosing regimen should be similar between CI and IB group
a. A loading dose should be given to continuous infusion group to ensure rapid attainment of target antibiotic concentration
b. An equal daily antibiotic dose should be given to continuous and bolus administration group
c. Antibiotic doses should be specified according to the patient’s body weight
d. Concomitant administration of other non-beta-lactam antibiotics should be allowed
PK/PD analysis Concurrent PK/PD analysis should be performed to support any findings
a, Measurements of antibiotic concentrations should be performed as long as contributing sites have necessary infrastructure to ensure apt sampling
b. PK/PD analysis should evaluate the relative ability of IB to achieve a Cmin greater than 4 x MIC of the offending pathogen for 40-70% of the dosing interval while for CI, a Css greater than 4 x MIC
Methods Design
  Preferably multicenter in nature and recruits participants from different regions to improve generalizability of results
  Patients
  Define eligibility criteria for participants to be included into trial
a. Definition of sepsis and severe sepsis should be described in detail
b. Inclusion and exclusion criteria used should be explained
  Randomization
  Detailed explanation on allocation sequence generation development
  Detailed allocation concealment mechanism
  Blinding/masking
  Outcome evaluators for the trial should be blinded to participants management
  Endpoints
  a. Endpoints selection should include primary (clinical outcome) and secondary (PK/PD; adverse event) endpoints
  b. Data collection on the observed bacterial resistance in the two treatment arms should occur