Santeon-CAP; Dexamethasone in Community-acquired Pneumonia

NCT ID: NCT01743755

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2018-09-13

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.

Detailed Description

Community-acquired pneumonia (CAP) is a common infection. Approximately 20 percent of all episodes of pneumonia result in hospitalization. It is the leading cause of community-acquired infection requiring intensive care unit (ICU) admission. In pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a mechanism by which invading pathogens are eliminated. However, this reaction of the innate immune system can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung. Interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. On ICU, early treatment with corticosteroids to attenuate systemic inflammation is widespread. At the same time, outside the ICU little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with CAP. Theoretically, early initiated administration of corticosteroids in the course of a CAP can lower systemic and pulmonary inflammation. This may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).

Conditions

Community-acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dexamethasone

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Dexamethasone tablet 6 mg, once daily for four consecutive days

Placebo

Placebo tablet, once daily for four consecutive days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet, once daily for four consecutive days

Interventions

Dexamethasone

Dexamethasone tablet 6 mg, once daily for four consecutive days

Intervention Type: DRUG

Placebo

Placebo tablet, once daily for four consecutive days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canisius-Wilhelmina Hospital

OTHER

Sponsor Role: collaborator

Onze Lieve Vrouw Hospital

OTHER

Sponsor Role: collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: collaborator

Maasstad Hospital

OTHER

Sponsor Role: collaborator

St. Antonius Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. WJW Bos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Willem Jan Bos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Jan Grutters, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Rob Janssen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Canisius-Wilhelmina Hospital

Frank Smeenk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Paul Bresser, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Onze Lieve Vrouwen Gasthuis

Stijn Konings, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Willem Blok, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Onze Lieve Vrouwen Gasthuis

Locations

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Catharina hospital Eindhoven

Eindhoven, North Brabant, Netherlands

OLVG

Amsterdam, North Holland, Netherlands

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 21636122 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33446608 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30603378 (View on PubMed)

Other Identifiers

2011-004566-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Santeon-CAP

Identifier Type: -

Identifier Source: org_study_id