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:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT03875560
Eligibility Criteria:
Inclusion Criteria
* Fever \> 38°C for \< 48 hours and clinical presentation consistent with dengue fever.
* Positive NS1 strip assay or reverse-transcriptase polymerase chain reaction (RT-PCR) assay for dengue virus.
* Informed consent form signed and dated by the patient.
* Subject able to give informed consent and able to comply with all study visits and all study procedures.
* Females of childbearing potential should be using and committed to continue using acceptable birth control methods.
* Sexual abstinence (inactivity) for 1 month prior to screening through study completion; or
* Intrauterine device (IUD) in place for at least 3 months prior to study through study completion; or
* Stable hormonal contraception for at least 3 months prior to study through study completion; or
* Surgical sterilization (vasectomy) of male partner at least 6 months prior to study.
* To be considered of non-childbearing potential, females should be surgically sterilized (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be post-menopausal and at least 3 years since last menses.
Exclusion Criteria
* One or more of the following dengue warning signs and symptoms:
* Intense and continuous abdominal pain (referred pain or on palpation);
* Persistent vomiting;
* Fluid accumulation (ascites, pleural effusion, or pericardial effusion);
* Postural hypotension and/or collapse;
* Painful hepatomegaly \> two centimeters below the right costal margin;
* Mucosal bleeding;
* Major bleeding (hematemesis and/or melena);
* Lethargy and/or irritability;
* Diminished urine output;
* Hypothermia;
* Progressive increase in hematocrit or 20% above baseline or normal for age;
* Abrupt drop in platelets;
* Respiratory discomfort.
* One or more of the following signs and symptoms of severe dengue, such as:
* Severe plasma extravasation, leading to shock evidenced by one or more of the following:
* Tachycardia;
* Cold distal extremities;
* Weak, thready pulse;
* Slow capillary refill (\> 2 seconds);
* Pulse pressure \< 20 mmHg;
* Tachypnea; or
* Oliguria (\<1.5 mL/kg/hr).
* Systolic blood pressure \< 90 mmHg or decrease \>40 mmHg;
* Cyanosis;
* Fluid accumulation with respiratory discomfort;
* Severe bleeding; or
* Severe organ impairment, evidenced by one or more of the following:
* Liver impairment (AST \>1000 U/L, international normalized ratio \>1.5);
* Renal impairment (serum creatinine ≥1.5 mg/dL); or
* Myocarditis, pericarditis, or clinical heart failure (by chest x-ray, echocardiography, electrocardiogram, or cardiac enzymes if available).
* Female who is pregnant, lactating or of childbearing potential.
* Self-reported or suspected congenital or acquired immunodeficiency (including HIV infection); or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the previous 3 months).
* Prior vaccination against dengue fever.
* Significant chronic illness that, in the opinion of the Investigator, would interfere with study validity, conduct or completion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03875560
Study Brief:
Protocol Section:
NCT03875560