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Oral Versus Intravenous Dexamethasone (OVID)

This study has been completed.
Information provided by (Responsible Party):
E.M.W. van de Garde, PharmD, St. Antonius Hospital Identifier:
First received: July 6, 2011
Last updated: January 14, 2014
Last verified: January 2014
The purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.

Condition Intervention Phase
Drug: Dexamethasone tablet 6 mg
Drug: Dexamethasone injection 4 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Oral Versus Intravenous Dexamethasone in Community-Acquired Pneumonia

Resource links provided by NLM:

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • Area Under the Concentration time curve [ Time Frame: 0-24 hours ]

Enrollment: 30
Study Start Date: August 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone oral Drug: Dexamethasone tablet 6 mg
Dexamethasone tablet 6 mg
Active Comparator: Dexamethasone intravenous Drug: Dexamethasone injection 4 mg
Dexamethasone injection 4 mg


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01390012

St. Antonius hospital
Nieuwegein, Utrecht, Netherlands, 3435CM
Sponsors and Collaborators
St. Antonius Hospital
  More Information

Responsible Party: E.M.W. van de Garde, PharmD, Dr., St. Antonius Hospital Identifier: NCT01390012     History of Changes
Other Study ID Numbers: OVID
Study First Received: July 6, 2011
Last Updated: January 14, 2014

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017