Biomarkers and treatment of pneumonia.

Biomarker guided antibiotic treatment in Community-Acquired Pneumoni (BIO-CAP)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002501-11-DK

Enrollment

300

Registered

2016-01-12

Start date

2016-04-01

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

community acquired pneumonia MedDRA version: 18.1 Level: HLT Classification code 10004048 Term: Bacterial lower respiratory tract infections System Organ Class: 100000004855

Interventions

Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: BENZYLPENICILLIN SODIUM CAS Number: 69-57-8 Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age > 17 years Admitted to Hospital and treated for pneumonia A new infiltrate on chest x-ray consistent with pneumonia At least one of the following symptoms: cough purulent expectoration fever pathological lung aucultation Not hospitalized 14 dyas prior to admission signed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: Active pulmonary tuberculosis Immunosuppression assesed by treateing physician Involentary treatment Planned antibiotic treatment for more than 3 days for another indaction than pneumonia Patients where acitve treatment is topped within the first 48 hours Women who are pregnant or breast-feeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of biomarker algorithms to reduce duration of antibiotic exposure in patients hospitalized with CAP compared to standard of care and to evaluate the efficacy of an algorithm based on C-reactive protein compared to an algorithm based on Procalcitonin for this purpose.;Secondary Objective: Not applicable;Primary end point(s): Number of days in antibiotic treatment Fraction of patients having antibtioc treatment stopped before day 6 after initiation;Timepoint(s) of evaluation of this end point: within 30 days	—

Measure

Time frame

Main Objective: To evaluate the efficacy of biomarker algorithms to reduce duration of antibiotic exposure in patients hospitalized with CAP compared to standard of care and to evaluate the efficacy of an algorithm based on C-reactive protein compared to an algorithm based on Procalcitonin for this purpose.;Secondary Objective: Not applicable;Primary end point(s): Number of days in antibiotic treatment Fraction of patients having antibtioc treatment stopped before day 6 after initiation;Timepoint(s) of evaluation of this end point: within 30 days

—

Secondary

Measure	Time frame
Secondary end point(s): a combined endpoint for sever outcome: death within 30 days relapse of pneumonia within 14 days after treatment cessation;Timepoint(s) of evaluation of this end point: within 30 days	—

Countries

Denmark

Contacts

Public ContactGertrud Baunbæk-Knudsen

Nordsjællands Hospital

gertrud.louise.baunbaek-knudsen@regionh.dk+4526220865

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026