Oral Versus Intravenous Dexamethasone

Pneumonia Clinical Trial

— OVID  

Official title:

Oral Versus Intravenous Dexamethasone in Community-Acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390012
• Other study ID #: OVID
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2011
• Last updated: January 14, 2014
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2014
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Dexamethasone tablet 6 mg
Dexamethasone tablet 6 mg
• Dexamethasone injection 4 mg
Dexamethasone injection 4 mg

Locations

Country	Name	City	State
Netherlands	St. Antonius hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration time curve		0-24 hours	No