The goal of this phase III study is to learn if ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years. The main question it aims to answer is: What medical problems do participants have when taking drug ZX-7101A for oral suspension or Oseltamivir phosphate for oral suspension? Researchers will compare drug ZX-7101A for oral suspension to active comparator: Oseltamivir phosphate for oral suspension to see if drug ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
169
ZX-7101A will be administered as oral suspension in a single dose on Day 1. Oseltamivir phosphate matching placebo will also be administered as oral suspension twice daily (BID) for 5 days.
Oseltamivir phosphate will be administered as oral suspension BID for 5 days. Participants receiving oseltamivir will also receive ZX-7101A matching placebo as oral suspension, single dose on Day 1.
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
The Number of Participants with Treatment-Related Adverse Event will be evalated as the change of vital signs, electrocardiogram, physical examination, and Laboratory test compared with the baseline.
Time frame: From day1 up to day15
Time to Alleviation of Influenza Signs and Symptoms
Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the following criteria are met (Standard a or b) and remain so for at least 21.5 hours: 1. Body temperature returns to normal (axillary temperature ≤ 37.2℃) 2. In the CARIFS scale, a score of 0 (no problem) or 1 (minor problem) for cough ,rhinobyon or nasal symptoms.
Time frame: From day1 up to day15
Duration of fever
Length of time taken by participants to return to afebrile state \[axillary temperature ≤ 37.2°C\] and remaining so for at least 21.5 hours.
Time frame: From day1 up to day15
Time to Alleviation of Symptoms
Symptom recovery time: Defined as the period from the start of the study treatment until all 16 assessment items in the CARIFS were evaluated as being asymptomatic or mild, and remained so for at least 21.5 hours.
Time frame: From day1 up to day15
Time to Return to Normal Health and Activity
Time to Return to Normal Health and Activity
Time frame: From day1 up to day15
The time influenza RNA turns negative
Defined as the time from initiation of treatment until the first influenza viral RNA falls below the lower limit of quantification (measured by RT-PCR)
Time frame: From day1 up to day15
The time Virus Titer turns negative
Defined as the time from initiation of treatment until the first viral titer falls below the lower limit of quantification
Time frame: From day1 up to day15
Change From Baseline in the Amount of Virus RNA (RT-PCR) and Influenza Virus Titer at each visit
Change From Baseline in the Amount of Virus RNA (RT-PCR, unit: log10virus particles/mL) and Influenza Virus Titer (unit: log10TCID50/ML) at each visit
Time frame: Baseline, Day 2,3,5,9,15
Percentage of Participants With Positive Influenza Virus Titer at each visit (measured by RT-PCR)
Percentage of Participants With Positive Influenza Virus Titer at each visit (measured by RT-PCR)(unit: %)
Time frame: Baseline, Day 2,3,5,9,15
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