NCT00471640

Brief Summary

The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

May 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 27, 2010

Status Verified

September 1, 2010

Enrollment Period

2.8 years

First QC Date

May 8, 2007

Last Update Submit

September 24, 2010

Conditions

Pneumonia

Keywords

pneumoniadexamethasonecommunity-acquired pneumonia

Outcome Measures

Primary Outcomes (1)

  • length of hospital stay

    30 days

Secondary Outcomes (1)

  • side-effects inflammation markers lung function

    30 days

Study Arms (2)

1

ACTIVE COMPARATOR

dexamethasone

Drug: dexamethasone

2

PLACEBO COMPARATOR

Placebo

Drug: dexamethasone

Interventions

dexamethasoneDRUG

4 days 5 mg

12

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 to 100 years with a community-acquired pneumonia.
  • Criteria to determine a community-acquired pneumonia:
  • 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 leukopenia (\<4000 cells/mm3)
  • CRP \> 15 mg/dl (three times upper limit of normal)

You may not qualify if:

  • o The following groups are excluded:
  • Immunocompromised patients:
  • Patients with a known congenital or achieved 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. (like cyclosporine, cyclofosfamide, azathioprine)
  • Patients with COPD who are on systemic corticosteroids for COPD.
  • Patients who require ICU treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gelderse Vallei Ede

Ede, Gelderland, Netherlands

Location

St Antonius Hosptial

Nieuwegein, Utrecht, 3430 EM, Netherlands

Location

Related Publications (3)

  • Raeven VM, Spoorenberg SM, Boersma WG, van de Garde EM, Cannegieter SC, Voorn GP, Bos WJ, van Steenbergen JE; Alkmaar study group; Ovidius study group. Atypical aetiology in patients hospitalised with community-acquired pneumonia is associated with age, gender and season; a data-analysis on four Dutch cohorts. BMC Infect Dis. 2016 Jun 17;16:299. doi: 10.1186/s12879-016-1641-9.

    PMID: 27317257DERIVED

  • Remmelts HH, van de Garde EM, Meijvis SC, Peelen EL, Damoiseaux JG, Grutters JC, Biesma DH, Bos WJ, Rijkers GT. Addition of vitamin D status to prognostic scores improves the prediction of outcome in community-acquired pneumonia. Clin Infect Dis. 2012 Dec;55(11):1488-94. doi: 10.1093/cid/cis751. Epub 2012 Aug 31.

    PMID: 22942205DERIVED

  • 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: 21636122DERIVED

MeSH Terms

Conditions

PneumoniaCommunity-Acquired Pneumonia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesCommunity-Acquired Infections

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • D Biesma, dr.

    St. Antonius Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2007

First Posted

May 10, 2007

Study Start

November 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 27, 2010

Record last verified: 2010-09

Locations

NL(2)