Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia
NCT ID: NCT03146182
Last Updated: 2017-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
300 participants
INTERVENTIONAL
2017-03-15
2019-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Procalcitonin as a Marker of Bacterial Pneumonia
NCT00415753
Diagnostic Accuracy of Infection Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia
NCT04652167
Procalcitonin Versus C-reactive Protein to Guide Therapy in Community Acquired Pneumonia
NCT01018199
Procalcitonin as a Marker of Antibiotic Therapy in Patients With Lower Respiratory Tract Infections
NCT02171338
Pneumonia Pathogens' Virulence Factors, Patient Inflammatory Markers, and Their Associations With Outcomes
NCT07011433
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Hypothesis: the duration of antibiotic exposure can be reduced when a biomarker algorithm - in addition to standard of care - is used to stop antibiotic treatment.
1\) CRP based guidelines can reduce duration of antibiotic exposure equally to procalcitonin based guidelines and 2) Either of these two biomarker algorithms ( CRP or PCT) are superior compared to standard of care.
Sample size. Preconditions: significance level (α) 5 % and power (β) 80 %. Test: unpaired T-test. Mean treatment time 11 days (SD 5) in this population. Relevant detection limit defined at 2 days. The bonferroni correction has been used to correct for the fact that 2 primary analysis will be performed, why α = 0.005/2 = 0.025. Estimated 100 patient in each arm, thus n = 300.
Site monitoring and auditing. The study is monitored by the unit for Good Clinical Practice, Bispebjerg Hospital, Denmark.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Patients are treated according to current local guidelines on antibiotic treatment for CAP.
No interventions assigned to this group
CRP
Patients are treated according to the CRP-algorithm. CRP is measured daily. Antibiotic treatment is stopped when CRP reach threshold value.
CRP-algorithm
a strategy based on CRP guided antibiotic stewardship
PCT
Patients are treated according to the PCT-algorithm. PCT is measured daily. Antibiotic treatment is stopped when PCT reach threshold value.
PCT-algorithm
a strategy based on PCT guided antibiotic stewardship
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CRP-algorithm
a strategy based on CRP guided antibiotic stewardship
PCT-algorithm
a strategy based on PCT guided antibiotic stewardship
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Not admitted to hospital within the last 14 days
* The patients has been prescribed antibiotic treatment for pneumonia
* The patient can comprehend the written and verbal information and has provided written consent.
Exclusion Criteria
* Active pulmonary tuberculosis
* Severe immunosuppression determined by the treating physician (i.e. treatment with highdose corticosteroid for more than 2 weeks, chemotherapy and neutropenia with neutrophils \< 0.5x109/l, ongoing treatment with biological drugs, chronic HIV-infection with CD4 cell count \< 350 mio./l, immunosuppression after organ transplantation).
* Pregnancy and breastfeeding
* Patients admitted to hospital and treated against their will.
* Terminal ill patients where active treatment is stopped within the first 48 hours of admission.
* Patients who are, from the date of inclusion, prescribed antibiotic treatment for more than 3 days on a different indication than pneumonia.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gertrud Baunbaek Egelund
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gertrud Baunbaek Egelund
M.D.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gertrud B Egelund, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of pulmonary and infectious diseases, Nordsjaellands Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nordsjællands Hospital.
Hillerød, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-002501-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BIO-CAP_NZH
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.