Oral Versus Intravenous Dexamethasone
OVID
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJanuary 15, 2014
January 1, 2014
1.2 years
July 6, 2011
January 14, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Area Under the Concentration time curve
0-24 hours
Study Arms (2)
Dexamethasone oral
ACTIVE COMPARATORDexamethasone intravenous
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Aged 18 years and older
- Presenting to the emergency room with suspected pneumonia (to be confirmed within 24 hours from admission) Pneumonia is defined as a new or progressive infiltrate on a chest X-ray plus at least two of the following criteria: cough, sputum production, temperature \>38°C or \<35°C, auscultatory findings consistent with pneumonia, leucocytosis or leucopenia (\>10 g/l, \<4 g/l or \>10% rods in leucocyte differentiation), C-reactive protein \>3 times the upper normal limit Corticosteroid naive at time of presentation
You may not qualify if:
- Patients needing corticosteroid treatment above study medication
- Failure to obtain written consent to participate
- Patients using medication drugs that interact with dexamethasone (i.e. phenytoin, barbiturates, rifampicin, erythromycin, clarithromycin, aprepitant, colchicine, everolimus, itraconazole, ketoconazole, pazopanib, tipranavir, and vinorelbine)
- Moribund patients (defined as expected to die within 24 hours)
- Patients with proven or suspected allergy to dexamethasone
- Patients not capable of taking tablets orally
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Antonius hospital
Nieuwegein, Utrecht, 3435CM, Netherlands
Related Publications (1)
Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295.
PMID: 24400953RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
July 6, 2011
First Posted
July 8, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
January 15, 2014
Record last verified: 2014-01