NCT05814302

Brief Summary

Fever is a frequent cause of admission to the Emergency Department (ED) around the world. While it can be caused by a wide range of conditions, the most effective treatment based on its etiology is still undetermined. This observational, prospective, single-center study enrolled adult patients who accessed the ED for fever, with the aim to define the most effective treatment for them.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
Last Updated

April 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

February 14, 2023

Last Update Submit

April 13, 2023

Conditions

Keywords

FeverParacetamolParacetamol/IbuprofenEmergency Department

Outcome Measures

Primary Outcomes (2)

  • body temperature

    the reduction of 1-degree of body temperature after 1 hour (T1) after the drug administration

    1 hour

  • Numerical Rating Scale (NRS)

    the reduction of 1-point for all associated symptoms on NRS after 1 hour (T1) after the drug administration. NRS is a "0-10" scale tool to assess pain severity, with zero that means "no pain" and 10 "the worst pain".

    1 hour

Secondary Outcomes (3)

  • the reduction of at least 2 points on the Numerical Rating Scale (NRS) after two hours (T2) after the drug administration

    2 hours

  • rescue therapy

    2 hours

  • adverse events

    2 hours

Interventions

Emergency physicians were free to administer paracetamol 1000 mg (P), the combination paracetamol 500 mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I)

Also known as: Combination of paracetamol/ibuprofen

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults \> 18 years old with fever and associated symptoms accessing the ED

You may qualify if:

  • fever with/without associated symptoms
  • adults who had given their consent to participate in the study.

You may not qualify if:

  • age \< 18 years old
  • contraindications or allergies to Paracetamol, Ibuprofen or to the combination Paracetamol/Ibuprofen
  • patients unable to take oral drugs
  • patients who did not express their consent to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

FeverEmergencies

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2023

First Posted

April 14, 2023

Study Start

June 1, 2021

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

April 14, 2023

Record last verified: 2023-02

Locations