Procalcitonin as a Marker of Antibiotic Therapy in Patients With Lower Respiratory Tract Infections

NCT02171338 | Unknown Phase 4

• 2 other identifiers: SJ-342SJ-RO-01, j.nr. 12-000179
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate weather or not the use of a procalcitonin(PCT)-based treatment in the daily clinical work could lower the consumption of antibiotics in patients with lower respiratory tract infections.

Conditions

Pneumonia; Acute Exacerbation of Chronic Obstructive Airways Disease

Keywords

Procalcitonin; Antibiotic therapy; Lower respiratory tract diseases

Outcome Measures

Primary Outcomes (1)

• Days of antibiotic treatment

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks, and up to 2 weeks after discharge.

Secondary Outcomes (1)

• Numbers of days admitted

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Other Outcomes (4)

• Patients with low PCT-level

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

• Recurrence within 30 days after discharge

  From 1 to 30 days after discharge

• Type of antibiotics

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks, and up to 2 weeks after discharge.

Study Arms (2)

Antibiotic treatment based on PCT-level

OTHER

Information regarding the PCT-levels in the intervention group is available to the treating doctor and the test subjects are randomized for treatment based on the level of PCT (PCT algorithm). With a PCT ≥0.25 µg/l and ≥0.10 µg/l for pneumonia and AECOPD respectively antibiotic treatment is advised to be started.

Other: PCT-level; Behavioral: Antibiotic treatment based on PCT-level

Control

NO INTERVENTION

Test subjects randomized for standard treatment (control group) are treated in accordance with the existing treatment guidelines of Holbaek Hospital. PCT-level will be measured but the treating doctor has no access to the result.

Interventions

PCT-level OTHER

PCT-level is available to the treating doctor.

Antibiotic treatment based on PCT-level

Antibiotic treatment based on PCT-level BEHAVIORAL

PCT-level is available to the treating doctor and the decision whether or not to treat with antibiotic is based on the level of PCT. The type of antibiotic chosen to treat is based on the existing antibiotic treatment guidelines of Holbaek Hospital and includes the antibiotics listed above.

Also known as: Avelox®, Azithromycin, Benzylpenicillin, Bioclavid®, Cefuroxim, Ciprofloxacin, Clarithromycin, Piperacillin/Tazobactam, Primcillin, Vepicombin®, Zinacef®

Antibiotic treatment based on PCT-level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized in Holbæk Hospital
• Clinical and paraclinical signs of pneumonia and/or AECOPD.

You may not qualify if:

• Unable to hand over written consent.
• Terminal patients.
• Patients with known abscess in the lungs and/or emphysema.
• Patients who have received treatment with strong doses (\>5mg/day) of biotin (vitamin B7 og B8) within the last eight hours.

Sponsors & Collaborators

• Holbaek Sygehus: lead
• Region Sjælland: collaborator
• Aase and Ejnar Danielsens Foundation: collaborator

Study Sites (1)

Holbæk Hospital

Holbæk, Holbæk, 4300, Denmark

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Moxifloxacin; Azithromycin; Penicillin G; Cefuroxime; Ciprofloxacin; Clarithromycin; Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Cephalosporins; Thiazines; Tazobactam; Penicillanic Acid; Piperacillin; Ampicillin; Sulfones; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Hans Ibsen, M.D., D.M.Sc

  Holbaek Sygehus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 24, 2014
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

DK (1)