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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
  Purpose
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
Pneumonia Drug: Dexamethasone tablet 6 mg Drug: Dexamethasone injection 4 mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Oral Versus Intravenous Dexamethasone in Community-Acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by E.M.W. van de Garde, PharmD, 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

  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT01390012


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

Publications:
Responsible Party: E.M.W. van de Garde, PharmD, Dr., St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01390012     History of Changes
Other Study ID Numbers: OVID
First Submitted: July 6, 2011
First Posted: July 8, 2011
Last Update Posted: January 15, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action