Trial · NCT01283009
Extended Steroid in Use in Community Acquired Pneumonia (CAP)(e)
NCT01283009, Phase 3, Completed, VA Office of Research and Development; results first posted 2020-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extended Steroid in Use in Community Acquired Pneumonia (CAP)(e). Trials, record NCT01283009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01283009
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended Steroid in Use in Community Acquired Pneumonia (CAP)(e)
- NCT number
- NCT01283009
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 584 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Community Acquired Respiratory Disease Syndrome
- Interventions
- Inactive Substance, Methylprednisolone
- First posted
- 2011-01-25
- Last updated
- 2020-10-08
- Results first posted
- 2020-10-08
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 60-day Mortality | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 60-day Mortality | 60-day | Numbers provided are overall and by stratum. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 60-day Mortality | Arm 1: Inactive Substance | Died on or prior to study day 60 / Yes | 50 | Participants | |
| 60-day Mortality | Arm 2: Methylprednisolone | Died on or prior to study day 60 / Yes | 47 | Participants | |
| 60-day Mortality | Arm 1: Inactive Substance | Died on or prior to study day 60 / No | 227 | Participants | |
| 60-day Mortality | Arm 2: Methylprednisolone | Died on or prior to study day 60 / No | 239 | Participants | |
| 60-day Mortality | Arm 1: Inactive Substance | Died on or prior to study day 60 / Unknown | 10 | Participants | |
| 60-day Mortality | Arm 2: Methylprednisolone | Died on or prior to study day 60 / Unknown | 11 | Participants | |
| 60-day Mortality | Arm 1: Inactive Substance | On Mechanical Ventilation at Study Entry / Yes | 24 | Participants | |
| 60-day Mortality | Arm 2: Methylprednisolone | On Mechanical Ventilation at Study Entry / Yes | 22 | Participants | |
| 60-day Mortality | Arm 1: Inactive Substance | On Mechanical Ventilation at Study Entry / No | 70 | Participants | |
| 60-day Mortality | Arm 2: Methylprednisolone | On Mechanical Ventilation at Study Entry / No | 72 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Inactive Substance | 287 | |
| Overall Study | STARTED | Arm 2: Methylprednisolone | 297 | |
| Overall Study | COMPLETED | Arm 1: Inactive Substance | 169 | |
| Overall Study | COMPLETED | Arm 2: Methylprednisolone | 180 | |
| Overall Study | NOT COMPLETED | Arm 1: Inactive Substance | 118 | |
| Overall Study | NOT COMPLETED | Arm 2: Methylprednisolone | 117 |
Source ClinicalTrials.gov
Adverse events472
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Arm 1: Inactive Substance | 5 | 287 | |
| serious | Anaemia | Blood and lymphatic system disorders | Arm 2: Methylprednisolone | 4 | 297 | |
| serious | Blood disorder | Blood and lymphatic system disorders | Arm 1: Inactive Substance | 0 | 287 | |
| serious | Blood disorder | Blood and lymphatic system disorders | Arm 2: Methylprednisolone | 1 | 297 | |
| serious | Haemorrhagic disorder | Blood and lymphatic system disorders | Arm 1: Inactive Substance | 1 | 287 | |
| serious | Haemorrhagic disorder | Blood and lymphatic system disorders | Arm 2: Methylprednisolone | 2 | 297 | |
| serious | Immune thrombocytopenic purpura | Blood and lymphatic system disorders | Arm 1: Inactive Substance | 0 | 287 | |
| serious | Immune thrombocytopenic purpura | Blood and lymphatic system disorders | Arm 2: Methylprednisolone | 1 | 297 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | Arm 1: Inactive Substance | 0 | 287 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | Arm 2: Methylprednisolone | 1 | 297 |
1 to 10 of 472Source ClinicalTrials.gov
See all 472 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Inactive Substance | 84 | 287 |
| Total, all-cause mortality | Arm 2: Methylprednisolone | 79 | 297 |
| Total, other adverse events | Arm 1: Inactive Substance | 0 | 0 |
| Total, other adverse events | Arm 2: Methylprednisolone | 0 | 0 |
| Total, serious adverse events | Arm 1: Inactive Substance | 162 | 287 |
| Total, serious adverse events | Arm 2: Methylprednisolone | 167 | 297 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35723686 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 1: Inactive Substance vs Arm 2: Methylprednisolone: deaths from any cause | Trial comparisons |
| Arm 1: Inactive Substance vs Arm 2: Methylprednisolone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01283009
GET https://conductscience.org/api/trials/v1/NCT01283009/events?page=2