Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults

April 20, 2019 updated by: Phramongkutklao College of Medicine and Hospital
The purpose of this study is to determine whether regular dosage of paracetamol causes transaminitis (hepatitis) and evaluate its potency in the treatment of dengue infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Phramongkutklao College of Medicine and Hospital
      • Lopburi, Thailand, 15000
        • Anandamahidol Hospital
      • Saraburi, Thailand, 18000
        • Fort Adisorn Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient age >18 years
  • Dengue infection diagnosed by NS1 antigen, Dengue immunoglobulin M antibody, or polymerase chain reaction
  • Admitted to the hospital
  • Written informed consent from patient or attending relative able to and willing to give informed consent

Exclusion Criteria:

  • Other possible cause of fever other than dengue infection
  • Pregnancy
  • Unable to take medication
  • Aminotransferase level above 3 times upper normal limit
  • Allergy to paracetamol or tramadol
  • Paracetamol indicated for condition other than dengue infection
  • Critically ill patient who need ICU or invasive ventilation support
  • History of cirrhosis
  • Unable to comunicate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paracetamol
Eligible patients will be randomised to receive Paracetamol prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)
Drug: Paracetamol
Paracetamol 500 mg x 1 tablets according to patient's body weight
Other Names:
  • Acetaminophen
Placebo Comparator: Placebo
Eligible patients will be randomised to receive Placebo prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)
Drug: Placebo
Placebo 500 mg x 1 tablets according to patient's body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with abnormal serum transaminase levels on the last day of fever
Time Frame: Day 1-8
Serum alanine transaminase and aspartate transaminase level will be measured at admission, and on every morning afterwards until the subject is discharged. The proportion of subjects with abnormal serum transaminase levels will be compared.
Day 1-8
Mean serum transaminase level
Time Frame: Day 1-8
Mean serum transaminase level will be compared.
Day 1-8
Mean change in serum transaminase levels
Time Frame: Day 1-8
The change in serum transaminase levels from baseline at admission will be compared.
Day 1-8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body temperature
Time Frame: 8 days
Axillary temperature will be recorded every 4 hours until discharge or 8 days after admission, whichever comes first.
8 days
Duration of fever
Time Frame: 8 days
Duration from the fever onset to the last febrile temperature will be compared.
8 days
Length of stay
Time Frame: 10 days
Duration from hospital admission to discharge will be compared.
10 days
Number of drug tablet used
Time Frame: 8 days
Number of drug tablet used will be compared, both paracetamol/placebo and tramadol.
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phramongkutklao College of Medicine and Hospital

Investigators

  • Study Director: Dhitiwat Changpradub, MD, Phramongkutklao College of Medicine and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 20, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMED2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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