A Phase 4 interventional study of Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor in Infection, Bacterial Infection and Sepsis, sponsored by Brahms AG. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-18.
Sponsored by Brahms AG · Phase 4, Interventional, and Treatment
The purpose of this study is to test whether a U.S. Food and Drug Administration (FDA) approved laboratory test (PCT Kryptor) can help doctors make better decisions on the need for antibiotic therapy in ICU patients with suspected infections.
The study is undertaken as prospective, randomized, controlled, multicenter trial. The study population, ICU patients with empiric antibiotic treatment due to suspected but unproven infection, is randomly assigned to either a Standard Care Group or a Procalcitonin (PCT) Guided Group. In the standard care group, antibiotic treatment would be based totally on clinical decision making with "traditional thought processes" (i.e., cultures, response to antibiotics, risk of untreated infection, other laboratory findings, etc.). The PCT guided group will use the same "traditional thought processes" and in addition the physician will be given access to a PCT value for Day 1 and Day 4 along with the recommended thresholds for likelihood of infection. In conjunction with other laboratory findings and clinical assessments the threshold of PCT is used to continue or discontinue empiric antibiotic treatment.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 11 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Brahms AG is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Standard treatment
PCT guided arm
Device: Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor
antibiotic treatment based on clinical decision making with "traditional thought processes" used in both groups. In addition the physician will be given access to Procalcitonin values with recommended thresholds for likelihood of infection.
Also known as: B.R.A.H.M.S, Kryptor, Procalcitonin
Days on antibiotics beginning with day 4 until the first day without antibiotics (up to max. 28 days follow up)
Time frame: 28 days
Days on antibiotics during ICU stay
Time frame: up to 28 days
Sepsis classification
Time frame: up to 28 days
SOFA score (modified)
Time frame: up to 28 days
ICU or hospital mortality up to 28 days
Time frame: up to 28 days
Frequency of infections
Time frame: up to 28 days
ICU and hospital length of stay
Time frame: up to 28 days
This study is terminated, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Brahms AG