Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01651728
Status:
UNKNOWN
Last Update Posted:
2012-08-06
First Post:
2012-07-24
Brief Title:
Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients A Study of Immunological Inflammatory and Coagulation Responses in Relation to Reduce Mortality During Hospitalization
Status:
UNKNOWN
Status Verified Date:
2012-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to assess the effect of simvastatin on immunology inflammatory and coagulation responses and mortality in elderly with pneumonia based The primary outcome is mortality event
The hypothesis of this study is that simvastatin therapy will reduce mortality in elderly with pneumonia
The hypothesis of this study is that simvastatin therapy will reduce mortality in elderly with pneumonia
Detailed Description:
Elderly patients diagnosed with pneumonia after getting information and signing informed consent will be included in this trial Simvastatin 20 mg will be administered to intervention group while control group will receive placebo Both groups will receive drugs or placebo for 30 days
Baseline data will be collected within 24 hours after admission Then the subject will be followed up for 30 days At the 7th day patients will be underwent several laboratory tests ie serum TNF-α Tumor Necrosis Factor alpha IFN-ϒ Interferon gamma CRP C-Reactive Protein and PAI-1 Plasminogen Activator Inhibitor-1 Death from all causes until 30 days will be recorded
Baseline data will be collected within 24 hours after admission Then the subject will be followed up for 30 days At the 7th day patients will be underwent several laboratory tests ie serum TNF-α Tumor Necrosis Factor alpha IFN-ϒ Interferon gamma CRP C-Reactive Protein and PAI-1 Plasminogen Activator Inhibitor-1 Death from all causes until 30 days will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1133-2403 | REGISTRY | International Clinical Trials Registry Platform WHO-ICTRP | None |