Effect of Montelukast in Preventing Dengue With Warning Signs in Dengue Patients

NCT04673422 | Completed Phase 2 DMC

• 1 other identifier: AMEDDengue2020
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 4

Brief Summary

This study aims to determine the efficacy of montelukast in reducing the incidence of dengue warning signs in adult dengue patients.

Conditions

Dengue; Dengue With Warning Signs; Dengue Shock Syndrome

Outcome Measures

Primary Outcomes (1)

• Rate of dengue with warning signs

  Rate of a composite outcome including * abdominal tenderness or pain * persistent vomiting * clinical fluid accumulation * mucosal bleeding * liver enlargement \>2cm * increase in hematocrit concurrent with decrease in platelet count However, lethargy will be excluded as a criterion for warning sign as almost all patients reported subjective lethargy.

  14 days or until the discontinuation of the follow up appointment by the attending physicians, whichever is shorter.

Secondary Outcomes (6)

• Rate of each component of composite outcome of dengue with warning signs

  14 days or until the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

• Rate of hospitalization

  14 days or until the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

• Length of hospital stay

  up to 90 days

• Rate of severe dengue

  14 days or until the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

• Rate of dengue shock

  14 days or until the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

Study Arms (2)

Montelukast

EXPERIMENTAL

a 10 mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

a 10 mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

Drug: Placebo

Interventions

Montelukast DRUG

A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

Montelukast

Placebo DRUG

A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years old
• diagnosis of dengue
• positive NS1 antigen or polymerase chain reaction (PCR) test

You may not qualify if:

• any warning sign of dengue
• concurrent diagnosis of other causes of fever, such as malaria or heat stroke
• pregnancy
• being unable to take medication by mouth
• critical illness needing intubation or admission to an intensive care unit
• being unable to communicate
• other indication of montelukast

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead

Study Sites (4)

Hatyai Hospital

Hat Yai, Changwat Songkhla, Thailand

Location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Ananda Mahidol Hospital

Lopburi, 15000, Thailand

Location

Fort Suranari Hospital

Nakhon Ratchasima, 30000, Thailand

Location

Related Publications (21)

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Related Links

• Ahmad A, Waseem T, Butt N, Randhawa F, Malik U, Shakoori T. Montelukast Reduces the Risk of Dengue Shock Syndrome in Dengue Patients. Tropical biomedicine. 2019;35:1115-22.

MeSH Terms

Conditions

Dengue; Severe Dengue

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

Study Officials

• Worapong Nasomsong, MD

  Phramongkutklao College of Medicine and Hospital

  PRINCIPAL INVESTIGATOR

• Worayon Chuerboonchai, MD

  Ananda Mahidol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a randomized, prospective, 2-arm, parallel-group, double-blind, placebo-controlled superiority trial

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: January 15, 2021
• Primary Completion: June 17, 2023
• Study Completion: June 17, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 6 months after publication
• Access Criteria: De-identified participant data can be requested by researchers for use in independent scientific research and will be provided following review and approval of the research proposal (including statistical analysis plan). Requests should be sent to the corresponding author after publication.

Locations

TH (4)