NCT01743755

Brief Summary

The present study is designed to investigate the beneficial effects of adjunctive dexamethasone therapy in patients admitted with community-acquired pneumonia, additionally aiming at assessing what patients benefit from dexamethasone treatment mostly. A large multicenter study will be conducted comparing a 4 days dexamethasone 6 mg per os course with placebo in 600 patients and with predefined subgroup analyses planned.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
413

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

November 22, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

5.6 years

First QC Date

November 22, 2012

Last Update Submit

April 17, 2019

Conditions

Community-acquired Pneumonia

Keywords

Community-acquired pneumoniaDexamethasoneCorticosteroid

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Discharge date will be the date on which the patient is clinically ready to be discharged (which means days of hospital stay on basis of social indication will be excluded from analyses). Median length of stay in an earlier CAP study performed in the St. Antonius Hospital in Nieuwegein was 6.5 days, thus patients will be followed during an expected average of 1 week.

    Hospital admission (= day 1 = timepoint at which patient presents in hospital) until hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week.

Secondary Outcomes (2)

  • Mortality

    day 30

  • ICU admission

    hospital admission (=day 1) until hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week.

Other Outcomes (7)

  • Mortality

    Day 365

  • S. pneumoniae prevalence

    Hospital admission (= day 1)

  • Renal damage

    Admission (=day 1) and day 30 (outpatient visist)

  • +4 more other outcomes

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR
Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Placebo tablet, once daily for four consecutive days

Drug: Placebo

Interventions

DexamethasoneDRUG

Dexamethasone tablet 6 mg, once daily for four consecutive days

Dexamethasone
PlaceboDRUG

Placebo tablet, once daily for four consecutive days

Placebo

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Chest radiograph showing new opacities.
  • In combination with two of the following findings:
  • Cough
  • Production of sputum
  • Temp \>38,0 °C or \<36,0 °C
  • Audible abnormalities by chest examination compatible with pneumonia
  • Leukocytosis (\>10.000 cells/mm3), leftward shift (\>10%) or leucopenia (\<4000 cells/mm3)
  • C-reactive protein \> 15 mg/l (three fold higher than the upper limit of normal)

You may not qualify if:

  • Immunocompromised patients:
  • Patients with a known congenital or acquired immunodeficiency.
  • Patients who received chemotherapy less than 6 weeks ago.
  • Patients who received corticosteroids in the last 6 weeks.
  • Patients who received immunosuppressive medication in the last 6 weeks (e.g. cyclosporin, cyclophosphamide, azathioprine).
  • Patients with chronic obstructive pulmonary disease who are on systemic corticosteroids.
  • Patients who require intensive care unit treatment.
  • Patients with tropical worm infection.
  • Patients with dexamethasone intolerance.
  • Pregnant and breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, 6532 SZ, Netherlands

Location

Catharina hospital Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

OLVG

Amsterdam, North Holland, 1091 AC, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Utrecht, 3430 EM, Netherlands

Location

Related Publications (3)

  • Meijvis SC, Hardeman H, Remmelts HH, Heijligenberg R, Rijkers GT, van Velzen-Blad H, Voorn GP, van de Garde EM, Endeman H, Grutters JC, Bos WJ, Biesma DH. Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 Jun 11;377(9782):2023-30. doi: 10.1016/S0140-6736(11)60607-7. Epub 2011 Jun 1.

    PMID: 21636122BACKGROUND

  • Wittermans E, Vestjens SMT, Spoorenberg SMC, Blok WL, Grutters JC, Janssen R, Rijkers GT, Smeenk FWJM, Voorn GP, van de Garde EMW, Bos WJW; Santeon-CAP Study Group; Members of the Santeon-CAP Study Group. Adjunctive treatment with oral dexamethasone in non-ICU patients hospitalised with community-acquired pneumonia: a randomised clinical trial. Eur Respir J. 2021 Aug 12;58(2):2002535. doi: 10.1183/13993003.02535-2020. Print 2021 Aug.

    PMID: 33446608DERIVED

  • Vestjens SMT, Wittermans E, Spoorenberg SMC, Grutters JC, van Ruitenbeek CA, Voorn GP, Bos WJW, van de Garde EMW. Inter-hospital variation in the utilization of diagnostics and their proportionality in the management of adult community-acquired pneumonia. Pneumonia (Nathan). 2018 Dec 25;10:15. doi: 10.1186/s41479-018-0059-0. eCollection 2018.

    PMID: 30603378DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Willem Jan Bos, MD, PhD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

  • Jan Grutters, Prof, MD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

  • Rob Janssen, MD, PhD

    Canisius-Wilhelmina Hospital

    PRINCIPAL INVESTIGATOR

  • Frank Smeenk, MD, PhD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

  • Paul Bresser, MD, PhD

    Onze Lieve Vrouwen Gasthuis

    PRINCIPAL INVESTIGATOR

  • Stijn Konings, MD, PhD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

  • Willem Blok, MD, PhD

    Onze Lieve Vrouwen Gasthuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2012

First Posted

December 6, 2012

Study Start

December 1, 2012

Primary Completion

July 13, 2018

Study Completion

September 13, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

NL(4)