Santeon-CAP; Dexamethasone in Community-acquired Pneumonia

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.

Conditions

• Community-acquired Pneumonia

Interventions

DRUG

Dexamethasone

Dexamethasone tablet 6 mg, once daily for four consecutive days

DRUG

Placebo

Placebo tablet, once daily for four consecutive days

Sponsors & Collaborators

• Canisius-Wilhelmina Hospital

  collaborator OTHER

• Onze Lieve Vrouw Hospital

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Maasstad Hospital

  collaborator OTHER

• St. Antonius Hospital

  lead OTHER

Principal Investigators

• Willem Jan Bos, MD, PhD · St. Antonius Hospital

• Jan Grutters, Prof, MD · St. Antonius Hospital

• Rob Janssen, MD, PhD · Canisius-Wilhelmina Hospital

• Frank Smeenk, MD, PhD · Catharina Ziekenhuis Eindhoven

• Paul Bresser, MD, PhD · Onze Lieve Vrouwen Gasthuis

• Stijn Konings, MD, PhD · Catharina Ziekenhuis Eindhoven

• Willem Blok, MD, PhD · Onze Lieve Vrouwen Gasthuis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2018-07-13

Completion

2018-09-13

Countries

• Netherlands

Study Locations