Oral Versus Intravenous Dexamethasone

NCT ID: NCT01390012

Last Updated: 2014-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Dexamethasone oral

Group Type ACTIVE_COMPARATOR

Dexamethasone tablet 6 mg

Intervention Type DRUG

Dexamethasone tablet 6 mg

Dexamethasone intravenous

Group Type ACTIVE_COMPARATOR

Dexamethasone injection 4 mg

Intervention Type DRUG

Dexamethasone injection 4 mg

Interventions

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Dexamethasone tablet 6 mg

Dexamethasone tablet 6 mg

Intervention Type DRUG

Dexamethasone injection 4 mg

Dexamethasone injection 4 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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E.M.W. van de Garde, PharmD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Antonius hospital

Nieuwegein, Utrecht, Netherlands

Site Status

Countries

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Netherlands

References

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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. doi: 10.1111/bcp.12295.

Reference Type RESULT
PMID: 24400953 (View on PubMed)

Other Identifiers

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OVID

Identifier Type: -

Identifier Source: org_study_id

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