Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.
Clin Microbiol Infect
; 23(8): 533-541, 2017 Aug.
Article
in En
| MEDLINE
| ID: mdl-27810466
ABSTRACT
OBJECTIVES:
To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI).METHODS:
Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process.RESULTS:
Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed.CONCLUSIONS:
These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Clinical Trials as Topic
/
Bacteremia
/
Endpoint Determination
/
Comparative Effectiveness Research
/
Anti-Bacterial Agents
Type of study:
Clinical_trials
/
Guideline
/
Observational_studies
Limits:
Adult
/
Humans
Language:
En
Journal:
Clin Microbiol Infect
Journal subject:
DOENCAS TRANSMISSIVEIS
/
MICROBIOLOGIA
Year:
2017
Document type:
Article