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Oral Versus Intravenous Dexamethasone (OVID)

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. Identifier: NCT01390012
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : January 15, 2014
Information provided by (Responsible Party):
E.M.W. van de Garde, PharmD, St. Antonius Hospital

Brief Summary:
The purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: Dexamethasone tablet 6 mg Drug: Dexamethasone injection 4 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Oral Versus Intravenous Dexamethasone in Community-Acquired Pneumonia
Study Start Date : August 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01390012

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St. Antonius hospital
Nieuwegein, Utrecht, Netherlands, 3435CM
Sponsors and Collaborators
St. Antonius Hospital
Publications of Results:
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Responsible Party: E.M.W. van de Garde, PharmD, Dr., St. Antonius Hospital Identifier: NCT01390012    
Other Study ID Numbers: OVID
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: January 15, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Dexamethasone acetate
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