A New Formulation of Intravenous Paracetamol for Fever Management

NCT ID: NCT02283203

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-03-31

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 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 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).

Conditions

Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

APOTEL max

Active drug; water for injection at a volume of 100ml with added 1g of paracetamol and inactive ingredients (ΑPOTEL max®), infused within 15 minutes. Available in 100ml bags.

Group Type: ACTIVE_COMPARATOR

APOTEL max

Intervention Type: DRUG

The study drug is provided in a form of bag with 100ml final volume and it is directly connected to the infusion device that leads to a catheter already cannulated in one antecubital vein.

Placebo

Placebo; water for injection at a volume of 100ml with added inactive ingredients, infused within 15 minutes. Available in 100ml bags.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo is provided in a form of bag with 100ml final volume and it is directly connected to the infusion device that leads to a catheter already cannulated in one antecubital vein. Placebo contains water for injection and inactive vehicles.

Interventions

APOTEL max

The study drug is provided in a form of bag with 100ml final volume and it is directly connected to the infusion device that leads to a catheter already cannulated in one antecubital vein.

Intervention Type: DRUG

Placebo

Placebo is provided in a form of bag with 100ml final volume and it is directly connected to the infusion device that leads to a catheter already cannulated in one antecubital vein. Placebo contains water for injection and inactive vehicles.

Intervention Type: DRUG

Other Intervention Names

Paracetamol solution for infusion, 1gram per 100ml bag; Water for injection and vehicles

Eligibility Criteria

Inclusion Criteria

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 38.50C.

6. 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 Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Attikon Hospital

OTHER

Sponsor Role: collaborator

University Hospital of Patras

OTHER

Sponsor Role: collaborator

University Hospital of Crete

OTHER

Sponsor Role: collaborator

Thriasio General Hospital of Elefsina

OTHER

Sponsor Role: collaborator

General Hospital Of Thessaloniki Ippokratio

OTHER

Sponsor Role: collaborator

General Hospital of Chalkida

OTHER_GOV

Sponsor Role: collaborator

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitrios Boumpas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Attikon Hospital

Charalambos Gogos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

George Samonis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete

Styliani Sympardi, MD

Role: PRINCIPAL_INVESTIGATOR

Thriasio General Hospital of Elefsina

Asterios Karagiannis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Thessaloniki Hippokrateion

Nikolaos Tsokos, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Halkida

Locations

General Hospital of Chalkida

Chalcis, , Greece

Attikon Hospital

Haidari/Athens, , Greece

University Hospital of Crete

Heraklion, , Greece

Thriasion Elefsis General Hospital

Magoula Attikis, , Greece

University Hospital of Patras

Rion/Patras, , Greece

General Hospital Of Thessaloniki Ippokratio

Thessaloniki, , Greece

Countries

Greece

References

Giamarellos-Bourboulis EJ, Spyridaki A, Savva A, Georgitsi M, Tsaganos T, Mouktaroudi M, Raftogiannis M, Antonopoulou A, Papaziogas V, Baziaka F, Sereti K, Christopoulos P, Marioli A, Kanni T, Maravitsa P, Pantelidou I, Leventogiannis K, Tsiaoussis P, Lymberopoulou K, Koutelidakis IM. Intravenous paracetamol as an antipyretic and analgesic medication: the significance of drug metabolism. J Pharmacol Sci. 2014;124(2):144-52. doi: 10.1254/jphs.13133fp. Epub 2014 Jan 30.

Reference Type: BACKGROUND

PMID: 24553403 (View on PubMed)

Other Identifiers

APOTEL-02

Identifier Type: -

Identifier Source: org_study_id