A study to compare Peramivir to Oseltamivir in children with acute influenza
- Conditions
- Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]acute uncomplicated influenzaMedDRA version: 20.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2021-001018-13-Outside-EU/EEA
- Lead Sponsor
- BioCryst Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
1. Male and non-pregnant female subjects age birth to 17 years of age.
2. Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature = 100°F (37.8°C) or rectal temperature = 101.3ºF (= 38.5ºC) with at least one respiratory symptom (cough or rhinitis) OR a positive influenza rapid antigen test. Fever will either be documented at the time of screening or must be reported by the parent or care-giver if treatment with an antipyretic was given within 6 hours of the screening assessment. Note: enrollment at each site by clinical symptoms alone will be approved by the Sponsor at the beginning of each influenza season once influenza has been confirmed in the local community. The Sponsor may withdraw approval for symptomatic screening in any season based upon trends in influenza surveillance data. Prior to sponsor approval or after approval is withdrawn, criteria 2 must be met by a positive influenza RAT test. During the period of approval, clinical symptoms alone will be adequate to meet criteria 2.
3. Onset of symptoms no more than 72 hours before presentation for screening for subjects < 2 years old.
4. Written informed consent by parents/guardians and assent by subjects = 7 years of age (or as applicable by local IRB or state requirements).
5. Females who have started their menses must either be:
• Sexually abstinent
• Using a highly effective form of birth control such as hormone contraception (oral, patch, injection, implant or vaginal ring) or 2 barrier methods (condom with spermicide and diaphragm)
Are the trial subjects under 18? yes
Number of subjects for this age range: 137
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Age > 17 years.
2. If less than 3 months of age at screening, history of premature birth (< 36 weeks 0 days gestation)
3. Weight less than 3.0 kg
4. Receipt of a live attenuated influenza vaccine (LAIV) within 14 days of presentation.
5. Females who are pregnant (positive urine or serum pregnancy test) or breast-feeding at screening.
6. Onset of symptoms more than 72 hours before presentation for screening for subjects <2 years old.
7. Development of symptoms while hospitalized for another indication
8. Subjects with identified risk factors for influenza complications but with uncomplicated influenza at the time of enrollment are not excluded. This includes lung disease, heart disease, blood disorders such as sickle cell anemia, metabolic disorders and neurologic disease. In addition, mild to moderate immunocompromised status such as due to renal disease, diabetes mellitus or HIV infection with a last known CD4+ count =200 cells/µl are not excluded.
9. Presence of severe immunocompromised status due to chronic disease or illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with > 10 mg prednisone or equivalent on a daily basis within 30 days of screening.
10. Complicated influenza characterized by any of the following:
a. ICU care
b. Evidence of organ dysfunction
c. Proven or suspected concomitant bacterial infection
d. Other known concomitant viral infection that is likely to complicate medical course such as RSV, parainfluenza virus and adenovirus. Co-infection with rhinovirus and enterovirus is allowed.
11. Previous participation in Study BCX1812-305 or participation in a study of any investigational drug or device within the last 30 days.
12. Subjects who cannot comply with all aspects of the study protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method