One RCT reported the use of microbiologic data to verify infection [ 28].
In 2009, the FDA provided a draft guidance to industry for the development, analysis, and presentation of microbiologic data for new systemic antibiotics, and described how provisional breakpoints are established using PK PD data before initiation of phase III clinical trials.
Patients from many sites across the 18 countries in Europe, Latin America, and Asia were enrolled in EU-CORE, allowing for the inclusion of a wide spectrum of infections and microbiologic data to be studied.
Bacterial load was tracked from origin using clinical and microbiologic data to provide an estimate at the start of sepsis.
Our study provides additional epidemiologic and microbiologic data to this discussion.
The purpose was to use local microbiologic data to develop institution-specific guidelines for VAP.
We used the laboratory information system at CLS PathNett Classic version 306, Cerner, Kansas City, MO, USA) to determine basic demographic information (age, sex, specimen submission site, date of hospital admission) and microbiologic data (location of isolate on patient and antimicrobial-susceptibility testing results) for all patients.
In the case of nodular disease, the frequent absence of systemic or pulmonary symptoms impede collection of microbiologic data, which would provide early clues to the possibility of mycobacterial infection as the etiology of lung nodules [ 18].
In other instances, the reports were either clearly not of cases of NTM disease (n = 27, 11%) or could not be determined (n = 95, 40%) because of a lack of microbiologic data, unclear reporting, or duplicate reports (n = 12, 5%).
