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NCT01283009 · ClinicalTrials.gov registry record · Phase 3
Extended Steroid in Use in Community Acquired Pneumonia (CAP)(e)
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 584
- Enrollment target
NCT01283009: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT01283009 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 584 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01283009, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 584 participants
- Enrollment target
Study Summary
The goal of the study is to determine whether providing early treatment with a glucocorticoid drug, called methylprednisolone, will improve survival in critically ill patients with severe community-acquired pneumonia (CAP). Pneumonia develops when bacteria and other agents invade the lungs. The body's immune system creates a response to produce inflammation to kill the bacteria. A moderate amount of inflammation is beneficial. But, in patients sick enough to be admitted to the ICU, inflammation is frequently out of control. When the body cannot regulate inflammation vital organs (brain, heart, lung, kidney, liver) may be damaged, contributing to death or residual organ damage for those who survive. Glucocorticoids help reduce inflammation. Recent studies have shown that when the body is unable to produce sufficient amounts of glucocorticoids, inflammation can get out of control. Under these circumstances, glucocorticoids given in small doses may help aid the body's ability to reduce inflammation and improve recovery. In a small preliminary trial, glucocorticoid treatment, in addition to standard antibiotic treatment, sped up recovery from pneumonia. It also decreased the length of hospital stay, and increased survival. This Cooperative Studies Program (CSP) study will be the first large-scale, prospective, randomized clinical trial evaluating whether or not this treatment improves recovery. In this study, at each site, patients with severe CAP will be assigned to one of two treatment groups. One group will receive methylprednisolone and the other will receive a placebo (an inert substance that will look like the drug). The investigators have chosen a total duration of treatment of 20 days (7 days full dose followed by slow reduction over 13 days) to prevent relapse of inflammation and allow the body to recover its own ability to produce glucocorticoid. All patients will also receive standardized management of CAP in accordance with current practice guidelines. The
Primary Outcome
The primary outcome is all-cause mortality at 60 days, defined by whether the patient has died by the end of study day 60.
Interventions
- DRUG Methylprednisolone
- DRUG Inactive Substance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 584 participants |
| Start Date | 2012-01-09 |
| Est. Completion | 2016-08-31 |
| Phase | Phase 3 |
What the finished NCT01283009 record still lists
NCT01283009 is an interventional study that assigns participants to a tested intervention. The registered 584 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 2 interventions - of which Methylprednisolone is the first listed.
NCT01283009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01283009 about?
NCT01283009 is a clinical study titled "Extended Steroid in Use in Community Acquired Pneumonia (CAP)(e)". The goal of the study is to determine whether providing early treatment with a glucocorticoid drug, called methylprednisolone, will improve survival in critically ill patients with severe community-acquired pneumonia (CAP). Pneumonia develops when bacteria and other agents invade the lungs. The body...
What is the current status of trial NCT01283009?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 584 participants. The study started on 2012-01-09. Estimated completion is 2016-08-31.
What interventions are being tested in trial NCT01283009?
The interventions under investigation include: Methylprednisolone (DRUG), Inactive Substance (DRUG).
Who is sponsoring clinical trial NCT01283009?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01283009's enrollment target sits among peer trials
584 652nd of 2000 higher than 1,349 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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