A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection
NCT ID: NCT01715909
Last Updated: 2018-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2014-01-22
2018-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oseltamivir: Standard dose
Participants will receive standard dose of oseltamivir capsules or suspension orally for 5 to maximum of 20 days depending on weight. Infants \<1 year of age will receive oseltamivir at a dose of 3 milligrams per kilogram (mg/kg).
Oseltamivir
Participants will receive standard dose (30 to 75 milligrams \[mg\]) or triple standard dose (90 to 225 mg) of oseltamivir orally daily for up to maximum of 20 days. Standard dose of oseltamivir according to weight (except infants): 30 mg twice daily for \</= 15 kilograms (kg) body weight participants; 45 mg twice daily for 15 to 23 kg body weight participants; 60 mg twice daily for 23 to 40 kg body weight participants; and 75 mg twice daily for greater than (\>) 40 kg body weight participants. Standard dose for infants is 3 mg/kg.
Oseltamivir: Triple dose
Participants will receive three times the standard dose of oseltamivir capsules or suspension orally for 5 to maximum of 20 days depending on weight and age. Infants \<1 year will receive standard dose at 3 mg/kg.
Oseltamivir
Participants will receive standard dose (30 to 75 milligrams \[mg\]) or triple standard dose (90 to 225 mg) of oseltamivir orally daily for up to maximum of 20 days. Standard dose of oseltamivir according to weight (except infants): 30 mg twice daily for \</= 15 kilograms (kg) body weight participants; 45 mg twice daily for 15 to 23 kg body weight participants; 60 mg twice daily for 23 to 40 kg body weight participants; and 75 mg twice daily for greater than (\>) 40 kg body weight participants. Standard dose for infants is 3 mg/kg.
Interventions
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Oseltamivir
Participants will receive standard dose (30 to 75 milligrams \[mg\]) or triple standard dose (90 to 225 mg) of oseltamivir orally daily for up to maximum of 20 days. Standard dose of oseltamivir according to weight (except infants): 30 mg twice daily for \</= 15 kilograms (kg) body weight participants; 45 mg twice daily for 15 to 23 kg body weight participants; 60 mg twice daily for 23 to 40 kg body weight participants; and 75 mg twice daily for greater than (\>) 40 kg body weight participants. Standard dose for infants is 3 mg/kg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral culture positive for influenza
* Immunocompromised
* Symptoms/signs suggestive of influenza like illness (ILI)
* Less than or equal to (\</=) 96 hours between onset of ILI and first dose of study drug
Exclusion Criteria
* Infants with post-menstrual age (PMA) \<36 weeks
* Clinical evidence of significant renal impairment
* Allergy to oseltamivir or excipients
* Hereditary fructose intolerance
* Received anti-viral treatment with activity against influenza (for example amantadine, rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or probenecid medication within 2 weeks prior to randomization
12 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Lucile Packard Child Hosp; Pediatric Pulmonary Division
Palo Alto, California, United States
The Children's Hospital; Pediatric Infectious Diseases
Aurora, Colorado, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Seattle Children's Hospital
Seattle, Washington, United States
UZ Brussel
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
São Paulo, São Paulo, Brazil
Casa de Saúde Santa Marcelina
São Paulo, São Paulo, Brazil
Children'S Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital For Sick Children; Infectious Disease Dept
Toronto, Ontario, Canada
McGill University; Montreal Children's Hospital; Oncology
Montreal, Quebec, Canada
Hospital Dr. Gustavo Fricke
Viña del Mar, , Chile
Centro Medico Imbanaco
Cali, , Colombia
Fundacion Clinica Valle de Lili, Department Rheumatology
Cali, , Colombia
Turun yliopistollinen keskussairaala
Turku, , Finland
Charité - Universitätsmedizin Berlin;Klinik für Allgemeine Pädiatrie
Berlin, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Dr. Von Haunersches Kinderspital
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Universitätsklinikum Tübingen UNI-Klinik für Kinder- und Jugendmedizin
Tübingen, , Germany
Childrens Regional Hospital Aglaia Kyriakou
Athens, , Greece
Aghia Sophia Children's Hospital; Pediatric Rheumatology Unit; 1st Department of Pediatrics
Athens, , Greece
Rambam Medical Center
Haifa, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Schneider Children's Medical Center of Israel; Pediatrics Department
Petah Tikva, , Israel
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat Gan, , Israel
The Dana Children's Hospital
Tel Aviv, , Israel
Ospedale Pediatrico Bambino Gesu
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa Pediatria 1
Milan, Lombardy, Italy
ASST DI MONZA; Divisione Malattie Infettive
Monza, Lombardy, Italy
Instituto Nacional de Pediatria; Departmento de Neurologia
México, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
Monterrey, , Mexico
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Children Hospital, Olsztyn; Ward of Pediatric Hematology and Oncology
Olsztyn, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego
Szczecin, , Poland
Medical University of Silesia; Department of Pediatric Hematology and Oncology
Zabrze, , Poland
Tygerberg Hospital; Rheumatology
Cape Town, , South Africa
WWCT Lakeview Hospital
Johannesburg, , South Africa
Chris Hani Baragwanath Hospital
Johannesburg, , South Africa
Hospital Sant Joan De Deu
Esplugues de Llobregas, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Countries
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Other Identifiers
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2012-002633-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NV25719
Identifier Type: -
Identifier Source: org_study_id
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