Fever due to infection of the upper respiratory tract, of the lower respiratory tract, acute pyelonephritis or of the skin and soft tissues. MedDRA version: 17.0 Level: PT Classification code 10049541 Term: Antipyresis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: APOTEL max solution for infusion 1g/100ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Paracetamol
CAS Number: 103-90-2
Other descriptive name: PARACETAMOL
Concentratio
Sponsors
UNI-PHARMA SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ALL following criteria should be met for the inclusion of a patient in the study: 1.Written informed consent by the patient 2.Patient of either gender 3.Age equal to or greater than 18 years old 4.Fever onset less than 24 hours 5.Body temperature greater than or equal to 38.5degC 6.Infection of the upper respiratory tract, of the lower respiratory tract, acute pyelonephritis or infection of the skin and soft tissues that can explain fever onset Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Patients who meet any of the below exclusion criteria cannot be enrolled in the study: 1.Age below 18 years old 2.Denial for written consent 3.Intake of paracetamol for any reason either orally or intravenously or intramuscularly the last 12 hours 4.Intake of any non-steroidal anti-inflammatory drug the last 8 hours 5.Intake of any steroidal anti-inflammatory drug the last 12 hours 6.History of liver cirrhosis 7.Serum creatinine greater than 3 mg/dl 8.Aspartate aminotransferase more than 3 times greater than the upper normal limit for the hospital lab 9.Known allergy to non-steroidal anti-inflammatory drugs or to paracetamol 10.Pregnancy or lactation 11.Active bleeding of the upper or the lower gastrointestinal tract 12.Thrombocytopenia defined as any absolute platelet count below 50000/mm3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A new formulation of paracetamol for intravenous administration has been manufactured in Greece by the industry Uni-Pharma (?POTEL ?ax®). According to this new formulation, 1g of paracetamol is provided as a flask diluted into 100ml volume with the possibility of immediate connection with the infusion device of the patient. This formulation provides the advantage of a dilution ready-to-use which equals considerable financial benefit; nursing staff is not pre-occupied with the preparation of dilutions and the amount of consumables required for the preparation of this dilution is significantly decreased. Taking into consideration that the antipyretic effect of intravenous paracetamol has never been studied compared with other agents in patients and available data come from studies in volunteers with experimental endotoxemia, the present study compares the efficacy of the new ?POTEL ?ax® formulation versus placebo for the management of fever of infectious origin. ;Secondary Objective: Pharmacokinetics of paracetamol;Primary end point(s): The comparative efficacy of intravenously administered ?POTEL ?ax® over placebo for the achievement of defervescence; deferevescence is defined as any body temperature equal to or lower than 37.1 degC.;Timepoint(s) of evaluation of this end point: 3 and 6 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •The comparison between the two study groups on the frequency and time to administration of rescue drug •The correlation between defervescence with the rescue drug with the efficacy of the initially administered type of study drug (placebo over active drug) •The correlation between the achievement of defervescence and the concentrations of free active paracetamol and its metabolites in the serum of the patients •The correlation between achievement of defervescence with the rescue drug and the need of further administration of other drugs as antipyretics at the discretion of the attending physicians ;Timepoint(s) of evaluation of this end point: 30 hours | — |
Countries
Greece
Contacts
Public ContactRegulatory Affairs department
Uni-Pharma SA
Outcome results
None listed