Last updated on February 2018

Ketotifen as a Treatment for Vascular Leakage During Dengue Fever

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: dengue fever | Pleural Effusion | Dengue
  • Age: Between 21 - 60 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Male or female, age 21-60 years
  2. Fever of 37.5C (directly measured or patient reported) of 72 hr duration.
  3. Positive Nonstructural protein 1 (NS1) strip assay or dengue polymerase chain reaction (PCR)
  4. Able and willing to give written or oral informed consent
  5. Willing to be an outpatient from Study Day 1 to 5, to undergo an MRI and chest X-ray day 1 at the hospital, to return to the hospital on day 5 for an MRI and chest X-ray, and return on Study Days 7 and 21.
  6. Willing to keep a diary of pain medication usage and side effects

Exclusion Criteria:

  1. Clinical signs and symptoms for severe dengue, such as: a. Persistent vomiting b. Altered mental state c. Liver enlargement > 2 cm
  2. A person with any of the following laboratory values: a. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 1000 U/L
  3. Current usage of any anticoagulant drugs including, but not limited to, aspirin, warfarin, or clopidogrel.
  4. Current usage of any drugs that are known to block the functions of ketotifen, such as propranolol.
  5. Current usage of oral anti-diabetic agents.
  6. Any other clinically significant acute illness within 7 days prior to first study drug administration.
  7. Patients with renal impairment.
  8. Exposure to any new investigational agent within 30 days prior to the study drug administration.
  9. Clinically significant abnormal physical examination unrelated to dengue infection.
  10. Females of childbearing potential who are pregnant, breast feeding, or unwilling to avoid pregnancy by the use of appropriate contraception, including oral and subcutaneous implantable hormonal contraceptives, condoms, diaphragm, or intrauterine device (IUD), during the period that the experimental drug is administered. Prospective female participants of childbearing potential must have a negative pregnancy test (point of care).
  11. Current significant medical condition or illness including cardiac arrhythmias, cardiomyopathy or other cardiac disease, immunocompromised state including known HIV infection, or any other illness that the Investigator considers should exclude the patient, especially those that require continuation of other medications likely to have an interaction with the study drug. Patients with a history of allergy will not be excluded unless the allergy may be directed to the Study Drug or other tablet ingredient.
  12. Any condition that would render the informed consent invalid, or limit the ability of the patient to comply with the study requirements.
  13. Any condition that, in the opinion of the investigator, would complicate or compromise the study or well being of the patient.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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