Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07409857
Eligibility Criteria:
Inclusion Criteria:
Patients, aged ≥ 1 day old, diagnosed with CBDs (e.g., hemophilia, von Willebrand disease, and other coagulation factor deficiency) who are diagnosed with dengue infection, based on WHO criteria as follow;
Clinical dengue infection:
Symptoms of high sustained fever for 3-7 days with 2 of the following: headache, retroorbital pain, myalgia, arthralgia/bone pain, hemorrhagic manifestation, positive tourniquet test, leukopenia (WBC ≤5000/uL)
Probable dengue infection:
Positive dengue IgM
Definite dengue infection:
Seroconversion of dengue IgM between acute and convalescent serum OR Rising of dengue IgG (HAI) at least 4 folds between acute and convalescent serum OR Positive NS1 Ag or other dengue-specific antigen tests
Dengue hemorrhagic fever:
Dengue infection with signs of bleeding (including positive tourniquet test) with platelet count \< 100,000/uL and with signs of leakage (one of the following):
1. Increase Hct at least 15-20% from baseline
2. Serum albumin \< 35 g/L
3. Presence of pleural effusion or ascites
Dengue shock syndrome:
1. Narrow pulse pressure (\< 20 mmHg)
2. Hypotension
3. Signs of poor tissue perfusion
Severity of DHF:
* Grade I: Positive tourniquet test
* Grade II: Spontaneous bleeding
* Grade III: Circulatory failure (narrow pulse pressure ≤20 mmHg, hypotension, or signs of poor tissue perfusion)
* Grade IV: Profound shock with undetectable blood pressure
Exclusion Criteria:
* Patients with CBDs with dengue infection who are not willing to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07409857
Study Brief:
Protocol Section:
NCT07409857