Clinical Trial: A New Formulation of Intravenous Paracetamol for Fever Management

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind, Randomized, Placebo-controlled Phase IV Clinical Study of the Efficacy and Safety of a New Formulation of Paracetamol for the Management of Fever of Infect

Brief Summary: The efficacy of intravenous paracetamol has never been compared with other drugs for the management of fever due to infections. Available data come from clinical studies conducted in healthy volunteers subject to experimental endotoxemia. The present study compares the efficacy of the new ΑPOTEL Μax® formulation versus placebo for the management of fever of infectious origin.

Detailed Summary: A new formulation of paracetamol for intravenous administration has been manufactured in Greece by the industry Uni-Pharma (ΑPOTEL Μax®). 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 ΑPOTEL Μax® formulation versus placebo for the management of fever of infectious origin (fever due to infection of the upper respiratory tract, of the lower respiratory tract, acute pyelonephritis or of the skin and soft tissues).
Sponsor: Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

Current Primary Outcome: Body temperature as a measure of to compare the efficacy of intravenously administered ΑPOTEL Μax® over placebo for the achievement of defervescence. [ Time Frame: 3 hours ]

The comparative efficacy of intravenously administered ΑPOTEL Μax® over placebo for the achievement of defervescence; defervescence is defined as any body temperature equal to or lower than 37.1 degC.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Need for the administration of rescue drug. [ Time Frame: 30 hours ]
    The comparison between the two study groups on the frequency and time to administration of rescue drug.
  • Comparison of defervescence with the rescue drug in the paracetamol arm with the placebo arm [ Time Frame: 30 hours ]
    The correlation between defervescence with the rescue drug with the efficacy of the initially administered type of study drug (placebo over active drug).
  • Correlation between serum concentrations of free active paracetamol and metabolites with the clinical efficacy of paracetamol [ Time Frame: 30 hours ]
    The correlation between the achievement of defervescence and the concentrations of free active paracetamol and its metabolites in the serum of the patients.
  • The administration of other antipyretics by the attending physicians after rescue drug in each study group [ Time Frame: 30 hours ]
    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.


Original Secondary Outcome: Same as current

Information By: Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

Dates:
Date Received: October 19, 2014
Date Started: February 2015
Date Completion:
Last Updated: March 21, 2016
Last Verified: March 2016