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Virus Therapy

Sisunatovir for Respiratory Syncytial Virus

Phase 1

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of Lower Respiratory Tract Infection (LRTI)

1 day to ≤60 months of age and weight ≥2.5 kg to ≤23 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 33

Awards & highlights

Study Summary

This trial is studying the safety and amount of sisunatovir in the blood of infants and children up to 5 years old who have a lower respiratory tract infection caused by respiratory syncytial

Who is the study for?

This trial is for infants and children up to 60 months old, weighing between 2.5 kg and 23 kg, who have pneumonia caused by RSV as confirmed by medical tests.Check my eligibility

What is being tested?

The study is testing the safety of sisunatovir and how much of it gets into the blood in young patients with RSV-caused pneumonia. Participants will receive varying doses of sisunatovir or a placebo over up to seven visits.See study design

What are the potential side effects?

While specific side effects are not listed here, they typically include reactions at the site where medicine is given, fever, changes in appetite or behavior, allergic reactions or other symptoms that will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have an infection in my lungs or airways below the voice box.

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I am between 1 day and 60 months old and weigh between 2.5kg and 23kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 33

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 33

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 33 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuations

Incidence of Treatment Emergent Adverse Events (TEAEs)

Incidence of clinically significant abnormal laboratory values

+1 more

Secondary outcome measures

Plasma concentrations of sisunatovir at steady state (Day 3 or later).

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: SisunatovirActive Control1 Intervention

Oral or NG tube

Group II: PlaceboPlacebo Group1 Intervention

Oral or Nasogastric tube (NG)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,918 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,113 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this research study?

"To fulfill the requirements of this clinical trial, a total of 108 eligible participants are needed. Patients have the opportunity to participate in this study at different locations, including Rambam Health Care Campus in Haifa and Hatsafon Research Unit / Children A Department in Rochester, Ḥeifā."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"Indeed, the information provided on clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking eligible participants. The initial posting of the trial was made on November 15th, 2023 and it underwent its most recent update on December 29th, 2023. In total, there are 11 different locations where a total of 108 patients will be enrolled in the study."

Answered by AI

In how many distinct settings is this medical study being conducted?

"At present, this study is being conducted at 11 different sites. These sites are located in various cities such as Haifa, Rochester, and Gresham among others. To minimize travel requirements for enrolled participants, it is advisable to choose the clinic closest to your location."

Answered by AI

What is the level of safety associated with Sisunatovir when administered to individuals?

"Based on the fact that this is a Phase 1 trial with limited data supporting safety and efficacy, our team at Power estimates the safety of Sisunatovir to be rated as 1."

Answered by AI

Does the current clinical trial have an age limit that allows individuals above 75 years old to participate?

"To participate in this clinical trial, patients must be within the age range of 1 day to 60 months. There are a total of 227 trials available for patients under the age of 18 and 603 trials for individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV

2024. "A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06102174.

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