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SIMVASTATINA EN LA NEUMONIA ADQUIRIDA EN LA COMUNIDAD QUE REQUIERE HOSPITALIZACION. ESTUDIO ALEATORIZADO, DOBLE-CIEGO, CONTROLADO CON PLACEBO (SIMVASTATIN IN COMMUNITY-ACQUIRED PNEUMONIA REQUIRING HOSPITALIZATION. A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL) - SIMVASTATIN IN COMMUNITY-ACQUIRED PNEUMONIA

SIMVASTATINA EN LA NEUMONIA ADQUIRIDA EN LA COMUNIDAD QUE REQUIERE HOSPITALIZACION. ESTUDIO ALEATORIZADO, DOBLE-CIEGO, CONTROLADO CON PLACEBO (SIMVASTATIN IN COMMUNITY-ACQUIRED PNEUMONIA REQUIRING HOSPITALIZATION. A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL) - SIMVASTATIN IN COMMUNITY-ACQUIRED PNEUMONIA

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-005096-93-ES
Enrollment
Unknown
Registered
2008-12-09
Start date
2009-09-03
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

NEUMONIA ADQUIRIDA EN LA COMUNIDAD QUE REQUIERE HOSPITALIZACION (COMMUNITY-ACQUIRED PNEUMONIA REQUIRING HOSPITALIZATION)

Interventions

Product Name: SIMVASTATIN Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use

Sponsors

Jordi Carratalá
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients (>18 years old) requiring hospitalization for community-acquired pneumonia. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy. Immunossupression (AIDS, neutropenia, transplantation). Prior therapy with statins. Therapy with azole drugs, macrolides, fibrate drugs, amiodarone, antidepressant drugs and/or calcium channel blockers. Lack of informed consent.

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine whether simvastatin is effective to reduce time to clinical stability in community-acquired pneumonia requiring hospitalization;Primary end point(s): Time to achieve clinical stability (days), as described elsewhere (Halm EA, et al. Time to clinical stability in patients hospitalizaed with community-acquired pneumonia: implications to practice guidelines. JAMA 1998; 279:1452-7).;Secondary Objective: To analyze immflamatory response and PO2/FiO2 at 48 hours. To determine the number of patients requiring intensive care unit and undergoing mechanical ventilation. To determine the number of patients developing in-hospital complications, drug adverse events, and rehospitalizations (<30 days after discharge). To determine early (<48 hours) and overall (<30 days) mortality.—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026