Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness

Octavio Ramilo, Rosanna Lagos, Xavier Sáez-Llorens, Joann Suzich, C. Kathy Wang, Kathryn M. Jensen, Brian S. Harris, Genevieve A. Losonsky, M. Pamela Griffin, Michael Desmond Nissen, Raymond Chuk, Rosanna Marietta Lagos Zuccone, Jose Manuel Pascual Novoa Pizarro, Ioulia Sakovets, Katia Gabriela Abarca Villaseca, Maria Isabel Ibanez, Maria Del Pilar Fernandez Fraile, Cecilia Silva, Philip Jeffrey Brown, Sandra LanceleyAdrian Trenholme, Charissa McBride-Miller, Elizabeth Castaño, Felice C. Adler-Shohet, Jay M. Leiberman, Nan O'Donnell, Kwabena Krow Ampofo, Chris Stockmann, Susana Chávez-Bueno, Sana Rettig, H. Cody Meissner, Karen Murray, C. Lucy Park, Rehka Bandepalli, Dwight Alden Powell, Pablo José Sanchez, Asuncion Mejias, José Rafael Romero, Kari A Simonsen

Research output: Contribution to journalArticle

44 Citations (Scopus)

Abstract

BACKGROUND: This study was conducted to determine whether treatment with motavizumab, an anti-respiratory syncytial virus (RSV) monoclonal antibody, would decrease viral load and improve clinical outcomes in previously healthy term infants hospitalized with RSV lower respiratory tract infection. METHODS: Infants hospitalized with lower respiratory tract infection and a positive RSV test performed locally were randomized to receive 1 intravenous dose of motavizumab (30 or 100 mg/kg) or placebo. Nasal wash samples were tested by real-time reverse transcriptase polymerase chain reaction at a central laboratory to determine viral load. Clinical data were collected during RSV hospitalization and at 12-month follow up. RESULTS: Of 118 infants, 112 were confirmed RSV positive by real-time reverse transcriptase polymerase chain reaction. In each study group, median (range) RSV load (log10 copies/mL) decreased at a similar rate from baseline to study day 7 [motavizumab 30 mg/kg: 8.35 (2.5-9.5) to 5.03 (2.5-6.8); motavizumab 100 mg/kg: 8.22 (5.5-9.7) to 4.25 (2.5-8.0); placebo: 8.02 (6.7-9.8) to 5.17 (2.5-7.3)]. Median (range) duration of hospitalization was 3.05 (0.8-16.0), 2.99 (1.0-25.0) and 2.88 (0.8-11.7) days for the motavizumab 30 mg/kg, motavizumab 100 mg/kg and placebo groups, respectively. Six (8%) motavizumab and 0 placebo recipients were admitted to the intensive care unit and 4 required mechanical ventilation. The incidence of wheezing episodes during the 12-month follow up was comparable for all 3 groups. CONCLUSIONS: Motavizumab had no appreciable effect on RSV viral load measured in the upper respiratory tract of children hospitalized for RSV lower respiratory tract infection. No differences were observed for duration of hospitalization, severity of illness measures or wheezing episodes during 12-month follow up in children treated with motavizumab or placebo.

Original languageEnglish (US)
Pages (from-to)703-709
Number of pages7
JournalPediatric Infectious Disease Journal
Volume33
Issue number7
DOIs
StatePublished - Jul 2014

Fingerprint

Respiratory Syncytial Virus Infections
Respiratory Syncytial Viruses
Viral Load
Placebos
Respiratory Tract Infections
Hospitalization
Therapeutics
Respiratory Sounds
Reverse Transcriptase Polymerase Chain Reaction
Real-Time Polymerase Chain Reaction
motavizumab
Hospitalized Child
Nose
Artificial Respiration
Respiratory System
Intensive Care Units
Monoclonal Antibodies

Keywords

  • RSV
  • infant
  • monoclonal antibody
  • pediatric
  • treatment

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases

Cite this

Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness. / Ramilo, Octavio; Lagos, Rosanna; Sáez-Llorens, Xavier; Suzich, Joann; Wang, C. Kathy; Jensen, Kathryn M.; Harris, Brian S.; Losonsky, Genevieve A.; Griffin, M. Pamela; Nissen, Michael Desmond; Chuk, Raymond; Zuccone, Rosanna Marietta Lagos; Pizarro, Jose Manuel Pascual Novoa; Sakovets, Ioulia; Villaseca, Katia Gabriela Abarca; Ibanez, Maria Isabel; Fraile, Maria Del Pilar Fernandez; Silva, Cecilia; Brown, Philip Jeffrey; Lanceley, Sandra; Trenholme, Adrian; McBride-Miller, Charissa; Castaño, Elizabeth; Adler-Shohet, Felice C.; Leiberman, Jay M.; O'Donnell, Nan; Ampofo, Kwabena Krow; Stockmann, Chris; Chávez-Bueno, Susana; Rettig, Sana; Meissner, H. Cody; Murray, Karen; Park, C. Lucy; Bandepalli, Rehka; Powell, Dwight Alden; Sanchez, Pablo José; Mejias, Asuncion; Romero, José Rafael; Simonsen, Kari A.

In: Pediatric Infectious Disease Journal, Vol. 33, No. 7, 07.2014, p. 703-709.

Research output: Contribution to journalArticle

Ramilo, O, Lagos, R, Sáez-Llorens, X, Suzich, J, Wang, CK, Jensen, KM, Harris, BS, Losonsky, GA, Griffin, MP, Nissen, MD, Chuk, R, Zuccone, RML, Pizarro, JMPN, Sakovets, I, Villaseca, KGA, Ibanez, MI, Fraile, MDPF, Silva, C, Brown, PJ, Lanceley, S, Trenholme, A, McBride-Miller, C, Castaño, E, Adler-Shohet, FC, Leiberman, JM, O'Donnell, N, Ampofo, KK, Stockmann, C, Chávez-Bueno, S, Rettig, S, Meissner, HC, Murray, K, Park, CL, Bandepalli, R, Powell, DA, Sanchez, PJ, Mejias, A, Romero, JR & Simonsen, KA 2014, 'Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness', Pediatric Infectious Disease Journal, vol. 33, no. 7, pp. 703-709. https://doi.org/10.1097/INF.0000000000000240
Ramilo, Octavio ; Lagos, Rosanna ; Sáez-Llorens, Xavier ; Suzich, Joann ; Wang, C. Kathy ; Jensen, Kathryn M. ; Harris, Brian S. ; Losonsky, Genevieve A. ; Griffin, M. Pamela ; Nissen, Michael Desmond ; Chuk, Raymond ; Zuccone, Rosanna Marietta Lagos ; Pizarro, Jose Manuel Pascual Novoa ; Sakovets, Ioulia ; Villaseca, Katia Gabriela Abarca ; Ibanez, Maria Isabel ; Fraile, Maria Del Pilar Fernandez ; Silva, Cecilia ; Brown, Philip Jeffrey ; Lanceley, Sandra ; Trenholme, Adrian ; McBride-Miller, Charissa ; Castaño, Elizabeth ; Adler-Shohet, Felice C. ; Leiberman, Jay M. ; O'Donnell, Nan ; Ampofo, Kwabena Krow ; Stockmann, Chris ; Chávez-Bueno, Susana ; Rettig, Sana ; Meissner, H. Cody ; Murray, Karen ; Park, C. Lucy ; Bandepalli, Rehka ; Powell, Dwight Alden ; Sanchez, Pablo José ; Mejias, Asuncion ; Romero, José Rafael ; Simonsen, Kari A. / Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness. In: Pediatric Infectious Disease Journal. 2014 ; Vol. 33, No. 7. pp. 703-709.
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T1 - Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness

AU - Ramilo, Octavio

AU - Lagos, Rosanna

AU - Sáez-Llorens, Xavier

AU - Suzich, Joann

AU - Wang, C. Kathy

AU - Jensen, Kathryn M.

AU - Harris, Brian S.

AU - Losonsky, Genevieve A.

AU - Griffin, M. Pamela

AU - Nissen, Michael Desmond

AU - Chuk, Raymond

AU - Zuccone, Rosanna Marietta Lagos

AU - Pizarro, Jose Manuel Pascual Novoa

AU - Sakovets, Ioulia

AU - Villaseca, Katia Gabriela Abarca

AU - Ibanez, Maria Isabel

AU - Fraile, Maria Del Pilar Fernandez

AU - Silva, Cecilia

AU - Brown, Philip Jeffrey

AU - Lanceley, Sandra

AU - Trenholme, Adrian

AU - McBride-Miller, Charissa

AU - Castaño, Elizabeth

AU - Adler-Shohet, Felice C.

AU - Leiberman, Jay M.

AU - O'Donnell, Nan

AU - Ampofo, Kwabena Krow

AU - Stockmann, Chris

AU - Chávez-Bueno, Susana

AU - Rettig, Sana

AU - Meissner, H. Cody

AU - Murray, Karen

AU - Park, C. Lucy

AU - Bandepalli, Rehka

AU - Powell, Dwight Alden

AU - Sanchez, Pablo José

AU - Mejias, Asuncion

AU - Romero, José Rafael

AU - Simonsen, Kari A

PY - 2014/7

Y1 - 2014/7

N2 - BACKGROUND: This study was conducted to determine whether treatment with motavizumab, an anti-respiratory syncytial virus (RSV) monoclonal antibody, would decrease viral load and improve clinical outcomes in previously healthy term infants hospitalized with RSV lower respiratory tract infection. METHODS: Infants hospitalized with lower respiratory tract infection and a positive RSV test performed locally were randomized to receive 1 intravenous dose of motavizumab (30 or 100 mg/kg) or placebo. Nasal wash samples were tested by real-time reverse transcriptase polymerase chain reaction at a central laboratory to determine viral load. Clinical data were collected during RSV hospitalization and at 12-month follow up. RESULTS: Of 118 infants, 112 were confirmed RSV positive by real-time reverse transcriptase polymerase chain reaction. In each study group, median (range) RSV load (log10 copies/mL) decreased at a similar rate from baseline to study day 7 [motavizumab 30 mg/kg: 8.35 (2.5-9.5) to 5.03 (2.5-6.8); motavizumab 100 mg/kg: 8.22 (5.5-9.7) to 4.25 (2.5-8.0); placebo: 8.02 (6.7-9.8) to 5.17 (2.5-7.3)]. Median (range) duration of hospitalization was 3.05 (0.8-16.0), 2.99 (1.0-25.0) and 2.88 (0.8-11.7) days for the motavizumab 30 mg/kg, motavizumab 100 mg/kg and placebo groups, respectively. Six (8%) motavizumab and 0 placebo recipients were admitted to the intensive care unit and 4 required mechanical ventilation. The incidence of wheezing episodes during the 12-month follow up was comparable for all 3 groups. CONCLUSIONS: Motavizumab had no appreciable effect on RSV viral load measured in the upper respiratory tract of children hospitalized for RSV lower respiratory tract infection. No differences were observed for duration of hospitalization, severity of illness measures or wheezing episodes during 12-month follow up in children treated with motavizumab or placebo.

AB - BACKGROUND: This study was conducted to determine whether treatment with motavizumab, an anti-respiratory syncytial virus (RSV) monoclonal antibody, would decrease viral load and improve clinical outcomes in previously healthy term infants hospitalized with RSV lower respiratory tract infection. METHODS: Infants hospitalized with lower respiratory tract infection and a positive RSV test performed locally were randomized to receive 1 intravenous dose of motavizumab (30 or 100 mg/kg) or placebo. Nasal wash samples were tested by real-time reverse transcriptase polymerase chain reaction at a central laboratory to determine viral load. Clinical data were collected during RSV hospitalization and at 12-month follow up. RESULTS: Of 118 infants, 112 were confirmed RSV positive by real-time reverse transcriptase polymerase chain reaction. In each study group, median (range) RSV load (log10 copies/mL) decreased at a similar rate from baseline to study day 7 [motavizumab 30 mg/kg: 8.35 (2.5-9.5) to 5.03 (2.5-6.8); motavizumab 100 mg/kg: 8.22 (5.5-9.7) to 4.25 (2.5-8.0); placebo: 8.02 (6.7-9.8) to 5.17 (2.5-7.3)]. Median (range) duration of hospitalization was 3.05 (0.8-16.0), 2.99 (1.0-25.0) and 2.88 (0.8-11.7) days for the motavizumab 30 mg/kg, motavizumab 100 mg/kg and placebo groups, respectively. Six (8%) motavizumab and 0 placebo recipients were admitted to the intensive care unit and 4 required mechanical ventilation. The incidence of wheezing episodes during the 12-month follow up was comparable for all 3 groups. CONCLUSIONS: Motavizumab had no appreciable effect on RSV viral load measured in the upper respiratory tract of children hospitalized for RSV lower respiratory tract infection. No differences were observed for duration of hospitalization, severity of illness measures or wheezing episodes during 12-month follow up in children treated with motavizumab or placebo.

KW - RSV

KW - infant

KW - monoclonal antibody

KW - pediatric

KW - treatment

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