Gram-Negative Bacterial Infection Clinical Trial
Official title:
The Attributable Burden and Costs of Infections Caused by Antibiotic-Resistant Gram-Negative Bacteria in Dutch Hospitals
This study aims to assess how large an additional disease burden and what extra costs are generated by antibiotic resistance in patients suffering from infections caused by gram-negative bacteria, such as Escherichia coli and Pseudomonas aeruginosa, in hospitals in the Netherlands.
This study addresses the following three aims:
1. To provide a more accurate estimate than currently available of the incremental disease
burden and attributable costs of antibiotic-resistant as compared to
antibiotic-sensitive gram-negative bacteria (i.e. Enterobacteriaceae and
non-fermenters). This analysis is focused on gram-negative infections for which patients
are hospitalized. In a less detailed manner, the same analysis of disease burden and
costs can be performed for acquiring a gram-negative infection during hospitalization.
2. To identify determinants associated with resistance in gram-negative infections, to the
extent that they are confounders of the relation between resistance and outcome.
3. To adapt and optimize existing methodology to measure the burden of resistance, among
others by calculating disability-adjusted life years (DALYs) which incorporate not
merely mortality, but also morbidity.
GRAND-ABC is designed as a prospective parallel matched cohort, which will run for a year in
each of the eight participating hospitals. The primary cohort is a random sample of all
Gram-negative infections occurring in a participating hospital during the study period. This
cohort can be divided on the basis of the primary determinant status (whether the
Gram-negative pathogen is resistant or not based on Dutch guideline for multi-drug resistant
organisms; Werkgroep Infectiepreventie (WIP). Bijzonder resistente micro-organismen (BRMO).
December 2012. http://www.wip.nl/free_content/Richtlijnen/130424_BRMO.pdf) into two parallel
subcohorts. Each patient in each of the subcohorts will be matched to one patient without a
gram-negative infection. Together these will form the secondary cohort of non-infected
patients: patients admitted to the hospital during the study period who are within the same
risk set as the infected patients.
For all patients data collection will be performed by review of medical files, which will
cover the entire admission during which they were included in the study, and all cause 30 day
mortality. Data collection for the hospital stay covers confounders and effect modifiers of
the associations studied, and feeds into the outcomes costs, DALYs and length of stay. For
the cohort with gram-negative infections, data on infection parameters and antibiotic
treatment parameters are also collected.
In addition, the subcohort with infections by multi-drug resistant organisms and a random 20%
of the subcohort with infections by sensitive organisms will be selected for follow-up,
consisting of sending questionnaires and renewed medical file review 30 days after the index
culture date. In the case of ongoing sequelae of the gram-negative infection, this procedure
is repeated 90 days after the index culture date. These questionnaires will feed into the
outcomes costs, DALYs and quality-adjusted life years (QALYs).
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