18 and older, any sex, with Community Acquired Respiratory Disease Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
60-day MortalityPrimary· 60-day
The primary outcome is all-cause mortality at 60 days, defined by whether the patient has died by the end of study day 60.
Died on or prior to study day 60
Group
Value
95% CI
Arm 1: Inactive Substance
50
Arm 2: Methylprednisolone
47
Arm 1: Inactive Substance
227
Arm 2: Methylprednisolone
239
Arm 1: Inactive Substance
10
Arm 2: Methylprednisolone
11
On Mechanical Ventilation at Study Entry
Group
Value
95% CI
Arm 1: Inactive Substance
24
Arm 2: Methylprednisolone
22
Arm 1: Inactive Substance
70
Arm 2: Methylprednisolone
72
Arm 1: Inactive Substance
2
Arm 2: Methylprednisolone
3
Not on Mechanical Ventilation
Group
Value
95% CI
Arm 1: Inactive Substance
26
Arm 2: Methylprednisolone
25
Arm 1: Inactive Substance
157
Arm 2: Methylprednisolone
167
Arm 1: Inactive Substance
8
Arm 2: Methylprednisolone
8
Adverse events — posted to ClinicalTrials.gov
Time frame: All SAEs were reported from Randomization to day 180..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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 study will take into consideration when assigning the treatment each participating site, and whether or not the patient requires mechanical ventilation at the time of assignment. Patients will be followed clinically for 180 days. The primary outcome is all cause 60-day mortality. Secondary outcomes are (1) in-hospital morbidity-mortality, including ventilator-free days, multiorgan dysfunction syndrome (MODS)-free days, duration of ICU and hospital stay, and hospital discharge; and (2) posthospital discharge morbidity-mortality, including cardiovascular complications, functional and general health status in the first 180 days, rehospitalization, and mortality at 1 year. Serial blood samples will also be collected and stored for future translational research relating longitudinal inflammation markers to clinical outcomes.
This study will advance knowledge on the relationship between inflammation and long-term outcome in severe CAP.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 8 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01283009.