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Oral Versus Intravenous Dexamethasone (OVID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
E.M.W. van de Garde, PharmD, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01390012
First received: July 6, 2011
Last updated: January 14, 2014
Last verified: January 2014
  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
Endpoint Classification: Bio-equivalence Study
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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 6, 2011
Last Updated: January 14, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014