NCT03146182

Brief Summary

The purpose of this study is to determine the efficacy of C-reactive protein and procalcitonin based guidelines versus standard of care to reduce duration of antibiotic exposure in patients hospitalized with community acquired pneumonia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

May 5, 2017

Last Update Submit

May 9, 2017

Conditions

Community Acquired Pneumonia

Keywords

C-reactive proteinProcalcitoninCommunity-acquired pneumoniaAntibiotic stewardship

Outcome Measures

Primary Outcomes (1)

  • Duration of antibiotic treatment

    Number of days in antibiotic treatment for pneumonia

    30 days from inclusion

Secondary Outcomes (2)

  • 30 day mortality

    30 days from inclusion

  • Relapse

    30 days from inclusion

Study Arms (3)

Control

NO INTERVENTION

Patients are treated according to current local guidelines on antibiotic treatment for CAP.

CRP

EXPERIMENTAL

Patients are treated according to the CRP-algorithm. CRP is measured daily. Antibiotic treatment is stopped when CRP reach threshold value.

Behavioral: CRP-algorithm

PCT

EXPERIMENTAL

Patients are treated according to the PCT-algorithm. PCT is measured daily. Antibiotic treatment is stopped when PCT reach threshold value.

Behavioral: PCT-algorithm

Interventions

CRP-algorithmBEHAVIORAL

a strategy based on CRP guided antibiotic stewardship

CRP
PCT-algorithmBEHAVIORAL

a strategy based on PCT guided antibiotic stewardship

PCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age or older admitted to hospital with community acquired pneumonia defined as a new infiltrate on x-ray and at least one of the following; cough, expectoration, dyspnea, fever and pathological lung-auscultation.
  • 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.

You may not qualify if:

  • Patient are unable to give written consent or patient does not understand the Danish language.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjællands Hospital.

Hillerød, 3400, Denmark

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Gertrud B Egelund, M.D.

    Department of pulmonary and infectious diseases, Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gertrud B Egelund, M.D.

CONTACT

004548293051gertrud.baunbaek.egelund@regionh.dk

Pernille Ravn, M.D.

CONTACT

004548296977pernille.ravn@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 9, 2017

Study Start

March 15, 2017

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

DK(1)