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Completed

NCT Number: NCT02833584

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

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.

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Key information

Conditions

Dengue Arbovirus Infections Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Transaminitis Vector Borne Diseases Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phramongkutklao College of Medicine and Hospital, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

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

Other names: Acetaminophen

Placebo

Drug

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

Primary outcomes

  1. 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.

  2. Mean serum transaminase level

    Time frame: Day 1-8

    Mean serum transaminase level will be compared.

  3. Mean change in serum transaminase levels

    Time frame: Day 1-8

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

Secondary outcomes

  1. Body temperature

    Time frame: 8 days

    Axillary temperature will be recorded every 4 hours until discharge or 8 days after admission, whichever comes first.

  2. Duration of fever

    Time frame: 8 days

    Duration from the fever onset to the last febrile temperature will be compared.

  3. Length of stay

    Time frame: 10 days

    Duration from hospital admission to discharge will be compared.

  4. Number of drug tablet used

    Time frame: 8 days

    Number of drug tablet used will be compared, both paracetamol/placebo and tramadol.

Sponsors and collaborators

Lead sponsor

Phramongkutklao College of Medicine and Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 14, 2016
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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