Trial · NCT02130986
Procalcitonin Antibiotic Consensus Trial (ProACT)
NCT02130986, Not applicable, Completed, University of Pittsburgh; results first posted 2019-01-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Procalcitonin Antibiotic Consensus Trial (ProACT). Trials, record NCT02130986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02130986
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Procalcitonin Antibiotic Consensus Trial (ProACT)
- NCT number
- NCT02130986
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,664 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Lower Respiratory Tract Infection (LRTI)
- Interventions
- Procalcitonin level, Results of procalcitonin (PCT) level to treating clinician, Provide procalcitonin guideline to treating clinician, Telephone Visit
- First posted
- 2014-05-06
- Last updated
- 2019-01-15
- Results first posted
- 2019-01-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Antibiotic Exposure Days | 30 days | Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30. |
| Primary | Number of Participants With Any Adverse Outcome | 30 days | Primary Safety Outcome - Combined endpoint of adverse outcomes (death, endotracheal intubation, vasopressors, renal failure, lung abscess/empyema, pneumonia in non-CAP patient, and hospital readmissions) that could be attributable to withholding antibiotics in lower respiratory tract infection (LRTI). Number is based on the number of participants that experienced any adverse outcome. |
| Secondary | Antibiotic Prescription in Emergency Department(ED) | While in the ED or before ED discharge (majority patients < 1 day) | Antibiotic prescription in the ED includes post-randomization receipt of antibiotics in ED and provision of an antibiotic prescription for patients at the time of discharge from the ED. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Antibiotic Exposure Days | 30 days | Mixed modeling was used to impute missing data for the intention-to-treat analysis for the primary outcome since not all patients could be reached for the 30 day interview (which collected 30 day antibiotic use). | days | MEAN |
| PRIMARY | Number of Participants With Any Adverse Outcome | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Antibiotic Prescription in Emergency Department(ED) | While in the ED or before ED discharge (majority patients < 1 day) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Antibiotic Exposure Days | Procalcitonin (PCT) Group | 4.2 | Standard Deviation 5.8 | days | |
| Total Antibiotic Exposure Days | Usual Care Group | 4.3 | Standard Deviation 5.6 | days | |
| Number of Participants With Any Adverse Outcome | Procalcitonin (PCT) Group | 96 | Participants | ||
| Number of Participants With Any Adverse Outcome | Usual Care Group | 109 | Participants | ||
| Antibiotic Prescription in Emergency Department(ED) | Procalcitonin (PCT) Group | 282 | Participants | ||
| Antibiotic Prescription in Emergency Department(ED) | Usual Care Group | 321 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Procalcitonin (PCT) Group | 830 | |
| Overall Study | STARTED | Usual Care (UC) Group | 834 | |
| Overall Study | COMPLETED | Procalcitonin (PCT) Group | 675 | |
| Overall Study | COMPLETED | Usual Care (UC) Group | 670 | |
| Overall Study | NOT COMPLETED | Procalcitonin (PCT) Group | 155 | |
| Overall Study | NOT COMPLETED | Usual Care (UC) Group | 164 |
Source ClinicalTrials.gov
Adverse events76
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 |
|---|---|---|---|---|---|---|
| other | Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Procalcitonin (PCT) Group | 1 | 826 | 1 |
| other | Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Usual Care Group | 0 | 830 | 0 |
| other | Death NOS | General disorders | Procalcitonin (PCT) Group | 1 | 826 | 1 |
| other | Death NOS | General disorders | Usual Care Group | 0 | 830 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Procalcitonin (PCT) Group | 2 | 826 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Usual Care Group | 0 | 830 | 0 |
| other | Bronchial infection | Infections and infestations | Procalcitonin (PCT) Group | 1 | 826 | 1 |
| other | Bronchial infection | Infections and infestations | Usual Care Group | 0 | 830 | 0 |
| other | Cognitive disturbance | Nervous system disorders | Procalcitonin (PCT) Group | 1 | 826 | 1 |
| other | Cognitive disturbance | Nervous system disorders | Usual Care Group | 0 | 830 | 0 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Procalcitonin (PCT) Group | 16 | 826 |
| Total, all-cause mortality | Usual Care Group | 10 | 830 |
| Total, other adverse events | Procalcitonin (PCT) Group | 20 | 826 |
| Total, other adverse events | Usual Care Group | 14 | 830 |
| Total, serious adverse events | Procalcitonin (PCT) Group | 14 | 826 |
| Total, serious adverse events | Usual Care Group | 9 | 830 |
Source ClinicalTrials.gov
Papers23
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01GM101197 | Procalcitonin Antibiotic Consensus Trial (ProACT) | HUANG, DAVID TOM | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES | 2013 to 2017 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Procalcitonin (PCT) Group vs Usual Care Group: Antibiotic Prescription in Emergency Department(ED) | Trial comparisons |
| Procalcitonin (PCT) Group vs Usual Care Group: deaths from any cause | Trial comparisons |
| Procalcitonin (PCT) Group vs Usual Care Group: Number of Participants With Any Adverse Outcome | Trial comparisons |
| Procalcitonin (PCT) Group vs Usual Care Group: 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/NCT02130986
GET https://conductscience.org/api/trials/v1/NCT02130986/events?page=2