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Oral Versus Intravenous Dexamethasone (OVID)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01390012
First Posted: July 8, 2011
Last Update Posted: January 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
E.M.W. van de Garde, PharmD, St. Antonius Hospital
July 6, 2011
July 8, 2011
January 15, 2014
August 2011
October 2012   (Final data collection date for primary outcome measure)
Area Under the Concentration time curve [ Time Frame: 0-24 hours ]
Same as current
Complete list of historical versions of study NCT01390012 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Oral Versus Intravenous Dexamethasone
Oral Versus Intravenous Dexamethasone in Community-Acquired Pneumonia
The purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Pneumonia
  • Drug: Dexamethasone tablet 6 mg
    Dexamethasone tablet 6 mg
  • Drug: Dexamethasone injection 4 mg
    Dexamethasone injection 4 mg
  • Active Comparator: Dexamethasone oral
    Intervention: Drug: Dexamethasone tablet 6 mg
  • Active Comparator: Dexamethasone intravenous
    Intervention: Drug: Dexamethasone injection 4 mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01390012
OVID
No
Not Provided
Not Provided
E.M.W. van de Garde, PharmD, St. Antonius Hospital
St. Antonius Hospital
Not Provided
Not Provided
St. Antonius Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP