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Completed

NCT Number: NCT01390012

Oral Versus Intravenous Dexamethasone

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

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Antonius hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone tablet 6 mg

Drug

Dexamethasone tablet 6 mg

Dexamethasone injection 4 mg

Drug

Dexamethasone injection 4 mg

Primary outcomes

  1. Area Under the Concentration time curve

    Time frame: 0-24 hours

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

Oral Versus Intravenous Dexamethasone in Community-Acquired Pneumonia

Acronym: OVID

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 8, 2011
Registry last updated
Jan 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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