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 |