NCT02833584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

June 21, 2016

Last Update Submit

April 20, 2019

Conditions

DengueTransaminitis

Keywords

Paracetamol

Outcome Measures

Primary Outcomes (3)

  • 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.

    Day 1-8

  • Mean serum transaminase level

    Mean serum transaminase level will be compared.

    Day 1-8

  • Mean change in serum transaminase levels

    The change in serum transaminase levels from baseline at admission will be compared.

    Day 1-8

Secondary Outcomes (4)

  • Body temperature

    8 days

  • Duration of fever

    8 days

  • Length of stay

    10 days

  • Number of drug tablet used

    8 days

Study Arms (2)

Paracetamol

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

ParacetamolDRUG

Paracetamol 500 mg x 1 tablets according to patient's body weight

Also known as: Acetaminophen
Paracetamol
PlaceboDRUG

Placebo 500 mg x 1 tablets according to patient's body weight

Placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Phramongkutklao College of Medicine and Hospital

Bangkok, 10400, Thailand

Location

Fort Adisorn Hospital

Changwat Sara Buri, 18000, Thailand

Location

Anandamahidol Hospital

Lopburi, 15000, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 31000133DERIVED

MeSH Terms

Conditions

Dengue

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Dhitiwat Changpradub, MD

    Phramongkutklao College of Medicine and Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

July 14, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

April 23, 2019

Record last verified: 2019-04

Locations

TH(3)