DengueNCT02833584
Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults
A study testing Paracetamol in people with Dengue and Transaminitis, run by Phramongkutklao College of Medicine and Hospital at 3 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dengue, Transaminitis
- What is being tested?
- Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 3 sitesThailand
- Study dates
- Sep 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Critically ill patient who need ICU or invasive ventilation support
- History of cirrhosis
- Unable to comunicate
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Phramongkutklao College of Medicine and Hospital
Bangkok, 10400
Fort Adisorn Hospital
Changwat Sara Buri, 18000
Anandamahidol Hospital
Lopburi, 15000
About this study
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
- Dengue, Transaminitis
- Being tested
- Paracetamol, Placebo
- Keywords
- Paracetamol
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Acetaminophen
Paracetamol 500 mg x 1 tablets according to patient's body weight
PlaceboDrug
Placebo 500 mg x 1 tablets according to patient's body weight
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1-8
Mean serum transaminase level
Mean serum transaminase level will be compared.
Measured: Day 1-8
Mean change in serum transaminase levels
The change in serum transaminase levels from baseline at admission will be compared.
Measured: Day 1-8
Secondary outcomes (4)
Body temperature
Axillary temperature will be recorded every 4 hours until discharge or 8 days after admission, whichever comes first.
Measured: 8 days
Duration of fever
Duration from the fever onset to the last febrile temperature will be compared.
Measured: 8 days
Length of stay
Duration from hospital admission to discharge will be compared.
Measured: 10 days
Number of drug tablet used
Number of drug tablet used will be compared, both paracetamol/placebo and tramadol.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhitiwat Changpradub, MD, Study director, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833584
- Sponsor's protocol ID
- AMED2016
- Status last verified
- Apr 2019
- First submitted
- 21 Jun 2016
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31000133
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults
- ClinicalTrials.gov ID
- NCT02833584
- Acronym / sponsor ID
- AMED2016
- Conditions
- Dengue, Transaminitis
- Keywords
- Paracetamol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Experimental | Drug: ParacetamolEligible patients will be randomised to receive Paracetamol prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day) |
| Placebo | Placebo comparator | Drug: PlaceboEligible patients will be randomised to receive Placebo prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: AcetaminophenParacetamol 500 mg x 1 tablets according to patient's body weight | Drug | Paracetamol |
| PlaceboPlacebo 500 mg x 1 tablets according to patient's body weight | Drug | Placebo |
Primary outcome
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.
Mean serum transaminase level
Time frame: Day 1-8
Mean serum transaminase level will be compared.
Mean change in serum transaminase levels
Time frame: Day 1-8
The change in serum transaminase levels from baseline at admission will be compared.
4 secondary outcomes
Body temperature
Time frame: 8 days
Duration of fever
Time frame: 8 days
Length of stay
Time frame: 10 days
Number of drug tablet used
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Derived from this study: PubMed 31000133Vasikasin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhitiwat Changpradub, MD study director
Phramongkutklao College of Medicine and Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol in people with Dengue and Transaminitis, run by Phramongkutklao College of Medicine and Hospital at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with abnormal serum transaminase levels on the last day of fever (time frame: Day 1-8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02833584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.