Skip to content

Oral Versus Intravenous Dexamethasone in Community-acquired pneumonia study

Oral Versus Intravenous Dexamethasone in Community-acquired pneumonia study - OVID study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36192
Enrollment
30
Registered
2011-06-30
Start date
2011-09-13
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lower respiratory tract infection Pneumonia

Interventions

Subjects will be assigned to 6 mg dexamethasone starting dose administered PO, followed by 3 times 6 mg dexamethasone PO once daily or 5,26 mg dexamethasonedisodiumphosphate (= 4 mg dexamethasone) st

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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, ausculatory 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

Exclusion criteria: - Patients needing corticosteroid treatment above study medication - Failure to obtain written consent to participate - Patients using fenytoine, barbiturates, rifampicine, erythromycin, clarithromycine, aprepitant, colchicine, everolimus, itraconazol, ketoconazole, pazopamib, tipranavir, vinorelbin - Moribund patients (defined as expected to die within 24 hours) - Patients with proven or suspected allergy to dexamethasone - Patient not capable of taking tablets orally

Design outcomes

Primary

MeasureTime frame
Extent of exposure reflected by the area under concentration time curve (AUC0-24)

Secondary

MeasureTime frame
Cmax, Tmax and Ctrough

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)