Status:
COMPLETED
A New Formulation of Intravenous Paracetamol for Fever Management
Lead Sponsor:
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Collaborating Sponsors:
Attikon Hospital
University Hospital of Patras
Conditions:
Fever
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 volunteer...
Detailed Description
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 provid...
Eligibility Criteria
Inclusion
- Written informed consent by the patient
- Patient of either gender
- Age equal to or greater than 18 years old
- Fever onset less than 24 hours
- Body temperature greater than or equal to 38.50C.
- Infection of the upper respiratory tract or of the lower respiratory tract or acute pyelonephritis or infection of the skin and soft tissues that can explain fever onset.
Exclusion
- Age below 18 years old
- Denial for written consent
- Intake of paracetamol for any reason either orally or intravenously or intramuscularly the last 12 hours
- Intake of any non-steroidal anti-inflammatory drug the last 8 hours
- Intake of any steroidal anti-inflammatory drug the last 12 hours
- History of liver cirrhosis
- Serum creatinine greater than 3 mg/dl
- Aspartate aminotransferase more than 3 times greater than the upper normal limit for the hospital lab
- Known allergy to non-steroidal anti-inflammatory drugs or to paracetamol
- Pregnancy or lactation
- Active bleeding of the upper or the lower gastrointestinal tract
- Thrombocytopenia defined as any absolute platelet count below 50000/mm3.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02283203
Start Date
February 1 2015
End Date
March 1 2016
Last Update
March 22 2016
Active Locations (6)
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1
General Hospital of Chalkida
Chalcis, Greece, 34100
2
Attikon Hospital
Haidari/Athens, Greece, 12462
3
University Hospital of Crete
Heraklion, Greece, 71110
4
Thriasion Elefsis General Hospital
Magoula Attikis, Greece, 19018