Phase
Condition
Influenza
Treatment
Baloxavir Marboxil
Clinical Study ID
Ages 1-11 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with symptoms suggestive of influenza with diagnosis confirmed by apositive local influenza test within 24 hours before full study screening.
Participants with a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test within 48 hours before full study screening.
Time interval between onset of influenza symptoms and the pre-dose examinations atscreening is 48 hours or less
Exclusion
Exclusion Criteria:
Participants with severe influenza virus infection requiring inpatient treatment.
Severely immunocompromised participants [including participants receivingimmunosuppressant therapy, or those with cancer or human immunodeficiency virus (HIV) infection] as defined by the investigator.
Participants with concurrent (non-influenza) infections requiring systemicanti-microbial and/or anti-viral therapy at the pre-dose examinations.
Treatment with baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir,rimantadine, umifenovir or amantadine within 30 days prior to screening.
Treatment with an investigational influenza-specific monoclonal antibody within 6months or 5 half-lives, whichever is longer, prior to screening.
Treatment with an investigational therapy within 30 days or 5 half-lives, whicheveris longer, prior to screening.
Known hypersensitivity to baloxavir marboxil or the drug product excipients.
Females who have commenced menarche (i.e., child-bearing potential).
Study Design
Connect with a study center
Medical Centre "Asklepii", OOD
Dupnitsa, 2600
BulgariaSite Not Available
Medical Centre "Asklepii", OOD; Office of Pulmonology and Phtisiatrics
Dupnitsa, 2600
BulgariaSite Not Available
MHAT " St. Ivan Rilski " Kozloduy
Kozloduy, 3320
BulgariaActive - Recruiting
MHAT City Clinic - Saint George
Montana, 3403
BulgariaActive - Recruiting
MHAT Stamen Iliev AD
Montana, 3400
BulgariaCompleted
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Ruse, 7002
BulgariaSite Not Available
MHAT Sliven - Military Medial Academy
Sliven, 8800
BulgariaActive - Recruiting
MHAT Sliven - Military Medial Academy; Department of Infectious Diseases
Sliven, 8800
BulgariaActive - Recruiting
AGPSMP Pediatric diseases South park OOD
Sofia, 1421
BulgariaActive - Recruiting
Medical Center Hera Sofia
Sofia, 1510
BulgariaCompleted
Medical Center Hera Sofia; Office of Pulmonology and Phtisiatrics
Sofia, 1510
BulgariaSite Not Available
NZOZ Salmed
??czna, 21-010
PolandActive - Recruiting
Centrum Medyczne K2J2
?ód?, 92-108
PolandActive - Recruiting
IN VIVO Sp. z o.o.
Bydgoszcz, 85-048
PolandActive - Recruiting
NZOZ Vitamed
Bydgoszcz, 85-079
PolandActive - Recruiting
Centrum Medyczne Pratia Cz?stochowa
Cz?stochowa, 42-200
PolandActive - Recruiting
Niepubliczny Zaklad Opieki Zdrowotnej "Amed"
Grojec, 05-600
PolandActive - Recruiting
Vita Longa Sp. z o.o.
Katowice, 40-748
PolandActive - Recruiting
NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska
Siemianowice ?l?skie, 41-103
PolandActive - Recruiting
Jaroslaw Kierkus Prywatna Prakyka Lekarska
Warszawa, 00-728
PolandActive - Recruiting
Centrum Medyczne K2J2
Wo?omin, 05-200
PolandActive - Recruiting
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
Wroc?aw, 53-149
PolandActive - Recruiting
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna 15706
SpainSite Not Available
Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría
Santiago de Compostela, LA Coruña 15706
SpainActive - Recruiting
Hospital Universitario La Fe; Hospital La Fe
València, Valencia 46026
SpainSite Not Available
Hospital Infantil Universitario Nino Jesus
Madrid, 28009
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario 12 de Octubre; Servicio de Pediatria
Madrid, 28041
SpainActive - Recruiting
Hospital Universitari i Politècnic La Fe
Valencia, 46026
SpainCompleted
Hospital Universitari i Politècnic La Fe; Servicio de Urgencias Pediátricas
Valencia, 46026
SpainActive - Recruiting
Central Alabama Research
Birmingham, Alabama 35209
United StatesActive - Recruiting
Central Alabama Research; Pediatrics
Birmingham, Alabama 35209
United StatesActive - Recruiting
Harrisburg Family Medical Center
Harrisburg, Arkansas 72432
United StatesActive - Recruiting
Avanza Medical Research Center
Pensacola, Florida 32503
United StatesActive - Recruiting
Tekton Research - Chamblee Georgia
Chamblee, Georgia 30341
United StatesSite Not Available
Tekton Research Lawrenceville
Lawrenceville, Georgia 30043
United StatesSite Not Available
Velocity Clinical Research at Primary Pediatrics Macon
Macon, Georgia 31210
United StatesActive - Recruiting
Clinical Research Prime
Idaho Falls, Idaho 83404
United StatesActive - Recruiting
Kentucky Pediatric Research Center
Bardstown, Kentucky 40004
United StatesActive - Recruiting
Velocity Clinical Research Lafayette
Lafayette, Louisiana 70508
United StatesActive - Recruiting
Velocity Clinical Research, Slidell
Slidell, Louisiana 31210
United StatesCompleted
Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803
United StatesActive - Recruiting
Velocity Clinical Research, Hastings
Hastings, Nebraska 68901
United StatesSite Not Available
Machuca Family Medicine
Las Vegas, Nevada 89104
United StatesActive - Recruiting
Ohio Pediatric Research Association
Dayton, Ohio 45414
United StatesActive - Recruiting
Frontier Clinical Research
Smithfield, Pennsylvania 15478
United StatesActive - Recruiting
Coastal Pediatric Research
Charleston, South Carolina 29414
United StatesActive - Recruiting
Tekton Research - Beaumont
Beaumont, Texas 77706
United StatesActive - Recruiting
Oak Cliff Research Company, LLC
Dallas, Texas 75218
United StatesCompleted
Oak Cliff Research Company, LLC
Richardson, Texas 75080
United StatesActive - Recruiting
Sun Research Institute
San Antonio, Texas 78215
United StatesActive - Recruiting
Tekton Research
San Antonio, Texas 78229
United StatesCompleted
Velocity Clinical Research, Salt Lake City
West Jordan, Utah 84088
United StatesActive - Recruiting
Frontier Clinical Research, LLC
Kingwood, West Virginia 26537
United StatesSite Not Available
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