Inhaled GM-CSF for Respiratory Virus-Associated Severe Pneumonia
NCT ID: NCT02601365
Last Updated: 2023-06-02
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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WITHDRAWN
PHASE1
INTERVENTIONAL
2019-03-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aerosolized Sargramostim
A self-controlled, open-label study to evaluate safety of Sargramostim administered by nebulization
Sargramostim 0.04 mcg/kg/dose
The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 0.04 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.
Sargramostim 0.2mcg/kg/dose
The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 0.2 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.
Sargramostim 1 mcg/kg/dose
The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 1 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.
Interventions
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Sargramostim 0.04 mcg/kg/dose
The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 0.04 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.
Sargramostim 0.2mcg/kg/dose
The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 0.2 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.
Sargramostim 1 mcg/kg/dose
The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 1 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Male or female Age ≥ 18 years and ≤ 80 years Able to understand and willing to sign a written informed consent document, or if incapacitated, has a designated legal representative who is able to understand and willing to sign a written informed consent document Able and willing to adhere to study visit schedule and study procedures Currently either oro-tracheally or naso-tracheally intubated
Diagnosis of respiratory viral infection determined by:
Polymerase Chain Reaction (PCR)-based Respiratory Virus Panel (RVP) positive for at least one of the following:
Respiratory syncytial virus (RSV) Influenza A/B Parainfluenza 1/2/3 Human Metapneumovirus Adenovirus Rhinovirus
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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References
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Thomas NJ, Shaffer ML, Willson DF, Shih MC, Curley MA. Defining acute lung disease in children with the oxygenation saturation index. Pediatr Crit Care Med. 2010 Jan;11(1):12-7. doi: 10.1097/PCC.0b013e3181b0653d.
Cakarova L, Marsh LM, Wilhelm J, Mayer K, Grimminger F, Seeger W, Lohmeyer J, Herold S. Macrophage tumor necrosis factor-alpha induces epithelial expression of granulocyte-macrophage colony-stimulating factor: impact on alveolar epithelial repair. Am J Respir Crit Care Med. 2009 Sep 15;180(6):521-32. doi: 10.1164/rccm.200812-1837OC. Epub 2009 Jul 9.
Huang FF, Barnes PF, Feng Y, Donis R, Chroneos ZC, Idell S, Allen T, Perez DR, Whitsett JA, Dunussi-Joannopoulos K, Shams H. GM-CSF in the lung protects against lethal influenza infection. Am J Respir Crit Care Med. 2011 Jul 15;184(2):259-68. doi: 10.1164/rccm.201012-2036OC. Epub 2011 Apr 7.
Sever-Chroneos Z, Murthy A, Davis J, Florence JM, Kurdowska A, Krupa A, Tichelaar JW, White MR, Hartshorn KL, Kobzik L, Whitsett JA, Chroneos ZC. GM-CSF modulates pulmonary resistance to influenza A infection. Antiviral Res. 2011 Nov;92(2):319-28. doi: 10.1016/j.antiviral.2011.08.022. Epub 2011 Sep 8.
Ghoneim HE, Thomas PG, McCullers JA. Depletion of alveolar macrophages during influenza infection facilitates bacterial superinfections. J Immunol. 2013 Aug 1;191(3):1250-9. doi: 10.4049/jimmunol.1300014. Epub 2013 Jun 26.
Steinwede K, Tempelhof O, Bolte K, Maus R, Bohling J, Ueberberg B, Langer F, Christman JW, Paton JC, Ask K, Maharaj S, Kolb M, Gauldie J, Welte T, Maus UA. Local delivery of GM-CSF protects mice from lethal pneumococcal pneumonia. J Immunol. 2011 Nov 15;187(10):5346-56. doi: 10.4049/jimmunol.1101413. Epub 2011 Oct 14.
Unkel B, Hoegner K, Clausen BE, Lewe-Schlosser P, Bodner J, Gattenloehner S, Janssen H, Seeger W, Lohmeyer J, Herold S. Alveolar epithelial cells orchestrate DC function in murine viral pneumonia. J Clin Invest. 2012 Oct;122(10):3652-64. doi: 10.1172/JCI62139. Epub 2012 Sep 10.
Hall MW, Knatz NL, Vetterly C, Tomarello S, Wewers MD, Volk HD, Carcillo JA. Immunoparalysis and nosocomial infection in children with multiple organ dysfunction syndrome. Intensive Care Med. 2011 Mar;37(3):525-32. doi: 10.1007/s00134-010-2088-x. Epub 2010 Dec 10.
Paine R 3rd, Standiford TJ, Dechert RE, Moss M, Martin GS, Rosenberg AL, Thannickal VJ, Burnham EL, Brown MB, Hyzy RC. A randomized trial of recombinant human granulocyte-macrophage colony stimulating factor for patients with acute lung injury. Crit Care Med. 2012 Jan;40(1):90-7. doi: 10.1097/CCM.0b013e31822d7bf0.
Luisetti M, Kadija Z, Mariani F, Rodi G, Campo I, Trapnell BC. Therapy options in pulmonary alveolar proteinosis. Ther Adv Respir Dis. 2010 Aug;4(4):239-48. doi: 10.1177/1753465810378023. Epub 2010 Jul 20.
Trapnell BC, Carey BC, Uchida K, Suzuki T. Pulmonary alveolar proteinosis, a primary immunodeficiency of impaired GM-CSF stimulation of macrophages. Curr Opin Immunol. 2009 Oct;21(5):514-21. doi: 10.1016/j.coi.2009.09.004. Epub 2009 Sep 30.
Tazawa R, Trapnell BC, Inoue Y, Arai T, Takada T, Nasuhara Y, Hizawa N, Kasahara Y, Tatsumi K, Hojo M, Ishii H, Yokoba M, Tanaka N, Yamaguchi E, Eda R, Tsuchihashi Y, Morimoto K, Akira M, Terada M, Otsuka J, Ebina M, Kaneko C, Nukiwa T, Krischer JP, Akazawa K, Nakata K. Inhaled granulocyte/macrophage-colony stimulating factor as therapy for pulmonary alveolar proteinosis. Am J Respir Crit Care Med. 2010 Jun 15;181(12):1345-54. doi: 10.1164/rccm.200906-0978OC. Epub 2010 Feb 18.
Herold S, Hoegner K, Vadasz I, Gessler T, Wilhelm J, Mayer K, Morty RE, Walmrath HD, Seeger W, Lohmeyer J. Inhaled granulocyte/macrophage colony-stimulating factor as treatment of pneumonia-associated acute respiratory distress syndrome. Am J Respir Crit Care Med. 2014 Mar 1;189(5):609-11. doi: 10.1164/rccm.201311-2041LE. No abstract available.
Papiris SA, Tsirigotis P, Kolilekas L, Papadaki G, Papaioannou AI, Triantafillidou C, Papaporfyriou A, Karakatsani A, Kagouridis K, Griese M, Manali ED. Long-term inhaled granulocyte macrophage-colony-stimulating factor in autoimmune pulmonary alveolar proteinosis: effectiveness, safety, and lowest effective dose. Clin Drug Investig. 2014 Aug;34(8):553-64. doi: 10.1007/s40261-014-0208-z.
Other Identifiers
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PSHCH0001
Identifier Type: -
Identifier Source: org_study_id
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