NCT03760419 (ICE-CAP1) is a NA clinical trial of Clinical Decision Support in Pneumonia Childhood, sponsored by Vanderbilt University Medical Center.

Who is sponsoring NCT03760419?

NCT03760419 is sponsored by Vanderbilt University Medical Center.

What drugs are being tested in NCT03760419?

Interventions in NCT03760419: Clinical Decision Support.

What condition does NCT03760419 study?

NCT03760419 studies Pneumonia Childhood.

Is NCT03760419 still recruiting?

NCT03760419 is currently completed. Last updated 8 December 2022.

Are results published for NCT03760419?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-12-08 · How we verify

NCT03760419: ICE-CAP1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Improving CarE for Community Acquired Pneumonia 1

Completed NA Results posted Last updated 8 December 2022

What this trial tests

NA trial testing Clinical Decision Support in Pneumonia Childhood in 1,027 participants. Completed in 30 September 2020.

Timeline

17 December 2018

Primary endpoint
30 September 2020

30 September 2020

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	1,027
Start date	17 December 2018
Primary completion	30 September 2020
Estimated completion	30 September 2020
Sites	1 location across United States

Drugs / interventions tested

Clinical Decision Support

Conditions studied

Pneumonia Childhood — all drugs for Pneumonia Childhood →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 6 Months to 18, any sex, with Pneumonia Childhood. 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.

Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours Primary · 18 months

The primary outcome is the percentage of children in which ALL antibiotic treatment prescribed in the first 24 hours of the encounter is guideline-concordant.

Overall

Group	Value	95% CI
Control Arm	255
Intervention Arm	284

Site A

Group	Value	95% CI
Control Arm	174
Intervention Arm	120

Site B

Group	Value	95% CI
Control Arm	81
Intervention Arm	164

Outpatient

Group	Value	95% CI
Control Arm	140
Intervention Arm	164

Inpatient

Group	Value	95% CI
Control Arm	93
Intervention Arm	99

ICU

Group	Value	95% CI
Control Arm	22
Intervention Arm	21

Age < 6 years

Group	Value	95% CI
Control Arm	163
Intervention Arm	192

Age >/= 6 years

Group	Value	95% CI
Control Arm	92
Intervention Arm	92

Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode Secondary · 18 months

This secondary outcome reports encounters in which established antibiotic stewardship guidelines are followed for ALL prescribing for the duration of the encounter (ED triage through hospital discharge).

Overall

Group	Value	95% CI
Control Arm	240
Intervention Arm	261

Site A

Group	Value	95% CI
Control Arm	163
Intervention Arm	111

Site B

Group	Value	95% CI
Control Arm	77
Intervention Arm	150

Outpatient

Group	Value	95% CI
Control Arm	140
Intervention Arm	164

Inpatient

Group	Value	95% CI
Control Arm	83
Intervention Arm	85

ICU

Group	Value	95% CI
Control Arm	17
Intervention Arm	12

Age <6 years

Group	Value	95% CI
Control Arm	156
Intervention Arm	175

Age >/= 6 years

Group	Value	95% CI
Control Arm	84
Intervention Arm	86

Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours Secondary · 18 months

This secondary outcome includes ANY guideline-concordant prescribing during the first 24 hours of the encounter.

Overall

Group	Value	95% CI
Control Arm	297
Intervention Arm	358

Site A

Group	Value	95% CI
Control Arm	198
Intervention Arm	144

Site B

Group	Value	95% CI
Control Arm	99
Intervention Arm	214

Outpatient

Group	Value	95% CI
Control Arm	145
Intervention Arm	168

Inpatient

Group	Value	95% CI
Control Arm	117
Intervention Arm	145

ICU

Group	Value	95% CI
Control Arm	35
Intervention Arm	45

Age <6 years

Group	Value	95% CI
Control Arm	189
Intervention Arm	242

Age >/= 6 years

Group	Value	95% CI
Control Arm	108
Intervention Arm	116

Any Guideline-Concordant Antibiotic Prescribing, Entire Episode Secondary · 18 months

This secondary outcome includes ANY guideline-concordant prescribing during the ENTIRE encounter (ED triage through hospital discharge).

Overall

Group	Value	95% CI
Control Arm	305
Intervention Arm	383

Site A

Group	Value	95% CI
Control Arm	200
Intervention Arm	146

Site B

Group	Value	95% CI
Control Arm	105
Intervention Arm	237

Outpatient

Group	Value	95% CI
Control Arm	145
Intervention Arm	168

Inpatient

Group	Value	95% CI
Control Arm	119
Intervention Arm	154

ICU

Group	Value	95% CI
Control Arm	41
Intervention Arm	61

Age <6 years

Group	Value	95% CI
Control Arm	195
Intervention Arm	256

Age >/= 6 years

Group	Value	95% CI
Control Arm	110
Intervention Arm	127

Adverse events — posted to ClinicalTrials.gov

Time frame: 18 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Arm

Serious: 83/478 (17%)

Deaths: 2/478

Intervention Arm

Serious: 74/549 (13%)

Deaths: 1/549

Serious adverse events (4 terms)

Reaction	System	Control Arm	Intervention Arm
ED revisit within 7 days	Respiratory, thoracic and mediastinal disorders	—	—
Re-hospitalization within 7 days	Respiratory, thoracic and mediastinal disorders	—	—
ED revisit within 72 hours	Respiratory, thoracic and mediastinal disorders	—	—
Re-hospitalization within 72 hours	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: ED revisit within 7 days, Re-hospitalization within 7 days, ED revisit within 72 hours, Re-hospitalization within 72 hours.

Data from ClinicalTrials.gov NCT03760419 adverse events section.

Sponsor's own description

Children with pneumonia presenting to the emergency department at Monroe Carell Jr. Children's Hospital at Vanderbilt or Children's Hospital of Pittsburgh will be potentially eligible for study. During intervention periods, providers caring for enrolled children will be presented with a detailed decision support strategy that emphasizes management in accordance with national guideline recommendations. The anticipated study duration is 18 months and, as this study does not include direct contact with enrolled subjects, there is no anticipated follow up.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Antibiotic clinical decision support for pneumonia in the ED: A randomized trial.
Williams DJ, Martin JM, Nian H, Weitkamp AO, et al · · 2023 · cited 12× · PMID 37042682 · DOI 10.1002/jhm.13101

Verify or expand the search:

Other trials of Clinical Decision Support

Trials testing the same drug.

NCT05777187 — Mitigation of Postoperative Delirium in High-Risk Patients · NA · terminated
NCT05634005 — Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence · NA · completed
NCT04773158 — Systematic Pediatric Assessment of Rome Criteria (SPARC) · NA · completed
NCT06033079 — Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP2) · NA · completed
NCT03584789 — De-Implementing Opioids for Dental Extractions · NA · completed

Other recruiting trials for Pneumonia Childhood

Currently open trials in the same condition.

NCT07414693 — Effect of Vitamin C on Length of Hospital Stay in Children With Severe Pneumonia · Phase 4 · recruiting
NCT06921993 — Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia · NA · recruiting

Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

NCT07005037 — Swallowing Impairments in ICU Survivors and Community-Dwelling Adults · not yet recruiting
NCT07527273 — Cognitive Enhancement in Recurrent Depression (The COG-D-R Study) · NA · not yet recruiting
NCT07295288 — Botox Injections in Non-Cranial Nerve VII Innervated Muscles for Facial Synkinesis · Phase 4 · not yet recruiting
NCT07431541 — Topical Carboxytherapy Paste Following Microneedling · Phase 1, PHASE2 · not yet recruiting
NCT07224711 — The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery · Phase 4 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03760419 (US National Library of Medicine, public domain)
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 Vanderbilt University Medical Center
Last refreshed: 8 December 2022

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/NCT03760419.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03760419: ICE-CAP1

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Clinical Decision Support

Other recruiting trials for Pneumonia Childhood

Other Vanderbilt University Medical Center trials

Verify against primary sources