Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT05814302
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2023-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Of Fever In The Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-04-13', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body temperature', 'timeFrame': '1 hour', 'description': 'the reduction of 1-degree of body temperature after 1 hour (T1) after the drug administration'}, {'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': '1 hour', 'description': '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".'}], 'secondaryOutcomes': [{'measure': 'the reduction of at least 2 points on the Numerical Rating Scale (NRS) after two hours (T2) after the drug administration', 'timeFrame': '2 hours', 'description': 'the secondary endpoint was to evaluate the number of patients (%) who obtained a reduction of at least 2 points on the NRS scale, in at least one of the symptoms associated with fever 2 hours after the antypiretic administration (T2). NRS is a "0-10" scale tool to assess pain severity, with zero that means "no pain" and 10 "the worst pain".'}, {'measure': 'rescue therapy', 'timeFrame': '2 hours', 'description': 'to identify the number of patients (%) who needed a rescue therapy'}, {'measure': 'adverse events', 'timeFrame': '2 hours', 'description': 'to identify the percentage (%) of adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fever', 'Paracetamol', 'Paracetamol/Ibuprofen', 'Emergency Department'], 'conditions': ['Fever']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Physicians were free to administer paracetamol 1000 mg (P), the combination paracetamol 500 mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I).The primary endpoint was both 1-degree and 1-point reduction in body temperature for all associated symptoms on the Numeric Rating Scale (NRS) after 1 hour (T1). Secondary endpoint was the reduction of at least 2 points on the NRS after two hours (T2). Adverse events, the needing of a rescue therapy and the response based on the underlying etiology (bacterial, viral, or immune/neoplastic) were also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults \\> 18 years old with fever and associated symptoms accessing the ED', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fever with/without associated symptoms\n* adults who had given their consent to participate in the study.\n\nExclusion Criteria:\n\n* age \\< 18 years old\n* contraindications or allergies to Paracetamol, Ibuprofen or to the combination Paracetamol/Ibuprofen\n* patients unable to take oral drugs\n* patients who did not express their consent to participate to the study'}, 'identificationModule': {'nctId': 'NCT05814302', 'briefTitle': 'Treatment Of Fever In The Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Treatment Of Fever And Associated Symptoms In The Emergency Department: Which Drug To Choose?', 'orgStudyIdInfo': {'id': '3710'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'otherNames': ['Combination of paracetamol/ibuprofen'], 'description': 'Emergency physicians were free to administer paracetamol 1000 mg (P), the combination paracetamol 500 mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli, IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}