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

Primary Purpose

Dengue, Transaminitis

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Paracetamol
Placebo
Sponsored by
Phramongkutklao College of Medicine and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dengue focused on measuring Paracetamol

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phramongkutklao College of Medicine and Hospital
  • Anandamahidol Hospital
  • Fort Adisorn Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Paracetamol

Placebo

Arm Description

Eligible patients will be randomised to receive Paracetamol prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)

Eligible patients will be randomised to receive Placebo prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)

Outcomes

Primary Outcome Measures

Proportion of subjects with abnormal serum transaminase levels on the last day of fever
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.
Mean serum transaminase level
Mean serum transaminase level will be compared.
Mean change in serum transaminase levels
The change in serum transaminase levels from baseline at admission will be compared.

Secondary Outcome Measures

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

Full Information

First Posted
June 21, 2016
Last Updated
April 20, 2019
Sponsor
Phramongkutklao College of Medicine and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02833584
Brief Title
Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phramongkutklao College of Medicine and Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue, Transaminitis
Keywords
Paracetamol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Experimental
Arm Description
Eligible patients will be randomised to receive Paracetamol prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Eligible patients will be randomised to receive Placebo prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Acetaminophen
Intervention Description
Paracetamol 500 mg x 1 tablets according to patient's body weight
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 500 mg x 1 tablets according to patient's body weight
Primary Outcome Measure Information:
Title
Proportion of subjects with abnormal serum transaminase levels on the last day of fever
Description
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.
Time Frame
Day 1-8
Title
Mean serum transaminase level
Description
Mean serum transaminase level will be compared.
Time Frame
Day 1-8
Title
Mean change in serum transaminase levels
Description
The change in serum transaminase levels from baseline at admission will be compared.
Time Frame
Day 1-8
Secondary Outcome Measure Information:
Title
Body temperature
Description
Axillary temperature will be recorded every 4 hours until discharge or 8 days after admission, whichever comes first.
Time Frame
8 days
Title
Duration of fever
Description
Duration from the fever onset to the last febrile temperature will be compared.
Time Frame
8 days
Title
Length of stay
Description
Duration from hospital admission to discharge will be compared.
Time Frame
10 days
Title
Number of drug tablet used
Description
Number of drug tablet used will be compared, both paracetamol/placebo and tramadol.
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhitiwat Changpradub, MD
Organizational Affiliation
Phramongkutklao College of Medicine and Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Phramongkutklao College of Medicine and Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Anandamahidol Hospital
City
Lopburi
ZIP/Postal Code
15000
Country
Thailand
Facility Name
Fort Adisorn Hospital
City
Saraburi
ZIP/Postal Code
18000
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
31000133
Citation
Vasikasin V, Rojdumrongrattana T, Chuerboonchai W, Siriwiwattana T, Thongtaeparak W, Niyasom S, Lertliewtrakool N, Jitsiri S, Changpradub D. Effect of standard dose paracetamol versus placebo as antipyretic therapy on liver injury in adult dengue infection: a multicentre randomised controlled trial. Lancet Glob Health. 2019 May;7(5):e664-e670. doi: 10.1016/S2214-109X(19)30032-4.
Results Reference
derived

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

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