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

Study Overview
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Brief Summary
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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.

Conditions
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Dengue, Transaminitis

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paracetamol<br>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<br>* Paracetamol 500 mg x 1 tablets according to patient's body weight<br>* Other names: Acetaminophen;|
| Placebo Comparator: Placebo<br>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<br>* Placebo 500 mg x 1 tablets according to patient's body weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paracetamol