Completed

Study Description:

The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.

GSK Study ID:

114373


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT01231620


Has Results Available Below
EudraCT Number:

2010-021621-12


Study Overview

Medical Conditions

Influenza

Product

zanamivir

Collaborators

N/A


Date

January 2011 to March 2015

Type

Interventional

Phase

3


Gender

All

Age

16 years - N/A

Accepts Healthy Volunteers

No


This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Australia, New South Wales, Westmead 2145Terminated
Australia, Queensland, Herston 4029Terminated
Australia, South Australia, Adelaide 5000Completed
Australia, South Australia, Bedford Park 5043Completed
Australia, Victoria, Clayton 3168Terminated
Australia, Victoria, Heidelberg 3084Completed
Australia, Victoria, Melbourne 3004Completed
Australia, Victoria, Melbourne 3050Terminated
Australia, Western Australia, Perth 6000Terminated
Belgium, Brussel 1090Completed
Belgium, Bruxelles 1070Completed
Belgium, Leuven 3000Completed
Belgium, Liege 4000Terminated
Brazil, Rio De Janeiro, Rio de Janeiro 21040-900Completed
Brazil, São Paulo, São Paulo 01308-050Completed
Canada, Alberta, Calgary T2N 2T9Completed
Canada, Alberta, Calgary T1Y 6J4Completed
Canada, Nova Scotia, Halifax B3H 3A7Terminated
Canada, Ontario, Hamilton L8N 4A6Completed
Canada, Ontario, Toronto M5G 2C4Completed
Canada, Québec, Chicoutimi G7H 5H6Terminated
Canada, Québec, Montreal H2W1T8Terminated
Canada, Québec, Montreal H1T 2M4Terminated
Canada, Québec, Trois-Rivières G8Z 3R9Completed
China, Beijing 100015Completed
China, Beijing 100044Terminated
China, Chengdu 610041Completed
China, Chongqing 400016Completed
China, Guangzhou 510120Completed
China, Hangzhou 310016Terminated
China, Shanghai 200025Completed
China, Tianjin 300052Terminated
China, Hainan, Haikou 570311Terminated
China, Hunan, Changsha 410005Terminated
China, Jiangxi, Nanchang 330006Completed
China, Jilin, Changchun 130041Terminated
China, Shaanxi, Xian 710032Terminated
China, Zhejiang, Hangzhou 310003Completed
Colombia, Bogotá Terminated
Czech Republic, Brno 625 00Terminated
Czech Republic, Brno - Bohunice 625 00Completed
Czech Republic, Hradec Kralove 500 05Terminated
Czech Republic, Praha 8 180 01Terminated
Denmark, Aarhus N 8200Terminated
Denmark, Hvidovre DK-2650Terminated
Denmark, Odense C 5000Completed
France, Dijon Cedex 21079Completed
France, Limoges cedex 87042Completed
France, Nîmes cedex 9 30029Terminated
France, Orléans cedex 2 45067Completed
France, Poitiers Cedex 86021Completed
France, Tours cedex 9 37044Completed
Germany, Baden-Wuerttemberg, Ulm 89081Terminated
Germany, Bayern, Erlangen 91054Completed
Germany, Bayern, Regensburg 93053Completed
Germany, Niedersachsen, Hannover 30625Terminated
Germany, Saarland, Homburg 66421Terminated
Greece, Chaidari 12462Completed
Greece, Goudi, Athens 11527Completed
Hong Kong, Kwun Tong Completed
Hong Kong, Shatin Terminated
Hong Kong, Tuen Mun Completed
Hungary, Debrecen 4031Terminated
Hungary, Kaposvár 7400Completed
Hungary, Miskolc 3529Terminated
Hungary, Szombathely 9700Terminated
Hungary, Székesfehérvár 8000Completed
India, Bangalore 560010Terminated
India, Civil Lines 141001Completed
India, Lucknow 226005Completed
India, Lucknow 226003Completed
India, Pune 411004Completed
India, Pune 411018Terminated
India, Trivandrum 695029Completed
Mexico, Aguascalientes, Aguascalientes 20230Completed
Mexico, Chihuahua, Chihuahua 31238Terminated
Mexico, Estado de México, Cuautitlán, Estado de México 54800Completed
Mexico, Jalisco, Guadalajara 44280Completed
Mexico, Nuevo León, San Nicolas de los Garza 66480Terminated
Netherlands, Nijmegen 6500 HBCompleted
New Zealand, Auckland Completed
New Zealand, Auckland 1001Completed
New Zealand, Auckland 1701Completed
New Zealand, Christchurch 8001Completed
New Zealand, Hamilton 3204Terminated
New Zealand, Hastings 4120Completed
New Zealand, Newtown Completed
Norway, Bergen 5053Completed
Norway, Trondheim 7030Completed
Poland, Chorzow 41-500Terminated
Poland, Debica 39-200Completed
Poland, Trzebnica 55-100Terminated
Poland, Warszawa 01-201Terminated
Russia, Barnaul 656024Completed
Russia, Barnaul 656038Completed
Russia, Saint-Petersburg 191167Completed
Russia, Sankt-Peterburg 197022Terminated
Russia, Smolensk 214006Terminated
Slovakia, Bratislava 833 05Completed
Slovakia, Martin 036 59Terminated
South Africa, Bellville 7530Completed
South Africa, Die Wilgers 0041Completed
South Africa, Les Marais 0084Completed
South Africa, Panorama 7500Terminated
South Africa, Worcester 6850Terminated
South Africa, Mpumalanga, Middelburg 1055Terminated
South Korea, Guro Gu 152703Completed
South Korea, Gyeonggi 442-723Terminated
South Korea, Kangwon-do 220-701Completed
South Korea, Seoul 150-030Completed
South Korea, Seoul 150-950Completed
Spain, Alicante 03010Completed
Spain, Badalona 08916Completed
Spain, Barcelona 08003Completed
Spain, Granada 18012Completed
Spain, Granada 18014Completed
Spain, L'Hospitalet de Llobregat 08907Completed
Spain, Madrid 28007Completed
Spain, Madrid 28040Completed
Spain, Madrid 28046Completed
Spain, Murcia 30003Completed
Spain, Oviedo 33006Terminated
Spain, Pama de Mallorca 07010Completed
Taiwan, Taipei 112Completed
Thailand, Bangkok 10400Terminated
Thailand, Bangkok 10700Terminated
United Kingdom, Bristol BS2 8HWTerminated
United Kingdom, Cardiff CF14 4XWCompleted
United Kingdom, Liverpool L7 8XPTerminated
United Kingdom, Manchester M13 9WLCompleted
United States, Alabama, Birmingham 35249Terminated
United States, Arizona, Phoenix 85023Terminated
United States, California, Chula Vista 91911Completed
United States, California, Escondido 92025Terminated
United States, California, Fullerton 92835Completed
United States, California, La Mesa 91942Completed
United States, California, LaJolla 92037Completed
United States, California, Oceanside 92056Terminated
United States, Colorado, Aurora 80045Completed
United States, Connecticut, Stamford 06902Completed
United States, Florida, Orlando 32806Completed
United States, Florida, Sarasota 34239Terminated
United States, Florida, Sunrise 33323Terminated
United States, Georgia, Atlanta 30342Completed
United States, Georgia, Augusta 30912Terminated
United States, Idaho, Idaho Falls 83404Terminated
United States, Illinois, Chicago 60611Terminated
United States, Illinois, Oak Park 60302Terminated
United States, Illinois, Peoria 61637Completed
United States, Iowa, Council Bluffs 51503Completed
United States, Kansas, Topeka 66604Terminated
United States, Kentucky, Louisville 40241Completed
United States, Massachusetts, Boston 02115Completed
United States, Michigan, Royal Oak 48073Completed
United States, Michigan, Troy 48085Completed
United States, Missouri, Saint Louis 63110-1093Completed
United States, Montana, Missoula 59802Terminated
United States, Nevada, Las Vegas 89109Completed
United States, New York, Valhalla 10595Terminated
United States, North Carolina, Asheville 28801Completed
United States, North Carolina, Chapel Hill 27599-7215Completed
United States, North Dakota, Bismarck 58504Terminated
United States, Ohio, Cleveland 44195Terminated
United States, Ohio, Columbus 43215Terminated
United States, Ohio, Toledo 43608Completed
United States, Pennsylvania, Bethlehem 18105Terminated
United States, Pennsylvania, Philadelphia 19107Completed
United States, Texas, Houston 77030Completed
United States, Virginia, Roanoke 24013Completed
United States, Wisconsin, Marshfield 54449Terminated

Study Design

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Yes
  • Masked Caregiver: Yes
  • Masked Investigator: Yes
  • Masked Assessor: Yes
Primary Outcomes:

  • Time to clinical response (TTCR) in participants with confirmed influenza
    Timeframe: Up to 42 days

Secondary Outcomes:

  • Percentage of participants with respiratory improvement
    Timeframe: Up to 42 days

  • Number of participants with all cause and attributable mortality at Day 14, at Day 28, and at the End of Study Visit
    Timeframe: On or before Day 14, Day 28, End of Study Visit (assessed up to 42 days)

  • Change from Baseline in the Katz Activities of Daily Living (ADL) score and each ADL activity score
    Timeframe: Baseline (Day 1) and up to 42 days

  • Median time to return to pre-morbid functional status as measured by the Katz ADL score and each ADL activity score
    Timeframe: Up to 42 days

  • Number of participants who returned to their pre-morbid functional status as assessed per the Katz ADL score and each ADL activity score at the end of the study
    Timeframe: Up to 42 days

  • Median time to return to the pre-morbid level of activity as measured by the 3-point scale
    Timeframe: Up to 42 days

  • Number of participants with the indicated clinical symptoms of influenza
    Timeframe: Up to 42 days

  • Median time of duration of clinical symptoms of influenza
    Timeframe: Up to 42 days

  • Number of participants with complications of influenza and associated antibiotic use
    Timeframe: Up to 42 days

  • Number of participants with the indicated ventilation status: modality of invasive and non-invasive ventilator support and oxygen supplementation
    Timeframe: Up to 42 days

  • Median time of duration of invasive and non-invasive ventilator support and oxygen supplementation
    Timeframe: Baseline (Day 1) and up to 42 days

  • Median time of duration of hospitalization and Intensive Care Unit (ICU) stay
    Timeframe: Day 1 to the end of the study (assessed up to 42 days)

  • Median time to the absence of fever and improved respiratory status, oxygen saturation, heart rate, and systolic blood pressure
    Timeframe: Baseline (Day 1) and up to 42 days

  • Median time to virologic improvement
    Timeframe: Baseline (Day 1) and up to 42 days

  • Change from Baseline in quantitative virus culture from nasopharyngeal swabs positive at Baseline
    Timeframe: Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable

  • Change from Baseline viral load (influenza A or B) by qPCR from nasopharyngeal swabs positive at Baseline
    Timeframe: Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable

  • Number of participants with no detectable viral RNA and the absence of cultivable virus in lower respiratory samples (bronchoalveolar lavage sample [BAL], endotracheal aspirate)
    Timeframe: Baseline (Day 1) and up to 42 days

  • Median time to no detectable viral RNA and the absence of cultivable virus in any obtained sample (upper and lower respiratory samples)
    Timeframe: Baseline (Day 1) and up to 42 days

  • Number of participants with resistance-associated mutations detected in the neuraminidase (NA) and hemagglutinin (HA) gene of influenza A and B viruses in nasopharyngeal swabs and endotracheal/BAL samples
    Timeframe: Baseline (Day 1) and up to 42 days

  • Number of participants with any adverse event (AE) considered to be related to study treatment
    Timeframe: Up to 42 days

  • Number of participants with any severe or Grade 3/4 AE
    Timeframe: Up to 42 days

  • Number of participants who permanently discontinued the study treatment due to an AE
    Timeframe: Up to 42 days

  • Number of participants who were permanently discontinued from the study due to an AE
    Timeframe: Up to 42 days

  • Number of participants with any severe or Grade 3/4 treatment-related AE
    Timeframe: Up to 42 days

  • Number of participants with the indicated chemistry laboratory values shifts from Baseline (Day 1) and up to 42 days
    Timeframe: Baseline (Day 1) and up to 42 days

  • Number of participants with the indicated hematology values shifts from Baseline (Day 1) and up to 42 days
    Timeframe: Baseline (Day 1) and up to 42 days

  • Number of participants with the indicated treatment-emergent (TE) Grade (G) 3/4 clinical chemistry toxicities
    Timeframe: Baseline (Day 1) and up to 42 days

  • Number of participants with the indicated treatment-emergent (TE) Grade 3/4 hematology toxicities
    Timeframe: Baseline (Day 1) and up to 42 days

  • Median quantity of oxygen delivery measured at Baseline (Day 1) and during the study
    Timeframe: Baseline (Day 1) and during the study

  • Number of participants assessed as normal/abnormal (clinically significant [CS] and not clinically significant [NCS]) for 12-lead electrocardiogram (ECG) at Baseline (Day 1) and Day 4
    Timeframe: Baseline (Day 1) and Day 4

  • Serum concentration of IV zanamivir
    Timeframe: Day 1 and Day 4

Arms:
  • 3

Interventions:

  • Drug: Zanamivir
  • Drug: Placebo to match zanamivir
  • Drug: Oseltamivir
  • Drug: Placebo to match oseltamivir

Keyword:

  • Seasonal Influenza, Pandemic, Orthomyxoviridae Infections, Influenza, Influenza A Virus, H1N1 Subtype, Enzyme Inhibitors, Influenza, seasonal, Respiratory Tract Diseases, Zanamivir, Pharmacologic Actions, Antiviral Agents, Anti-Infective Agents, H1N1, Neuraminidase inhibitor, Influenza B virus
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 626

Clinical Publications:

  • Marty F, Vidal J, Clark C, Gupta S, Merino E, Garot D, Chapman M, Jacobs F, Noriega ER, Husa P, Shortino D, Watson H, Yates P, Peppercorn A. Intravenous zanamivir or oral oseltamivir for hospitalised patients with influenza: an international, randomised, double-blind, double-dummy, Phase III trial. Lancet Respir Med. 2017;5:135-46.