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Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT01075178
Collaborator
(none)
2,036
Enrollment
37
Locations
42.1
Duration (Months)
55
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is an observational, non-interventional, retrospective cohort study of infants with hemodynamically significant congenital heart disease (HSCHD) who were less than 24 months of age when the first dose of palivizumab was administered (CASES), and infants who were diagnosed with hemodynamically significant congenital heart disease but did not receive palivizumab in a historical respiratory syncytial virus (RSV) season during the first 24 months of life (CONTROLS). CASES are matched to CONTROLS based on RSV season, age, type of cardiac lesion, and type of prior corrective cardiac surgery. Subject medical records are reviewed for occurrences of the clinical end points of infection, arrhythmia, and/or death that meet criteria for serious adverse events. The groups will be compared for number and percent of subjects who experience these primary serious adverse events (both individually and collectively) during a defined 8-month chart review period.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2036 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease
    Study Start Date :
    Jul 1, 2006
    Actual Primary Completion Date :
    Jan 1, 2010
    Actual Study Completion Date :
    Jan 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Palivizumab-treated subjects (CASES)

    HSCHD infants, <2 yrs old at first dose of palivizumab
    Non-palivizumab-treated subjects (CONTROLS)

    HSCHD infants, <2 yrs old that did not receive palivizumab

    Outcome Measures

    Primary Outcome Measures

    1. Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death [8-month chart review period in CASES and CONTROLS]

      The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event

    2. Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection. [8-month chart review period in CASES and CONTROLS]

      The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event

    3. Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia [8-month chart review period in CASES and CONTROLS]

      The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event

    4. Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death [8-month chart review period in CASES and CONTROLS]

      The number of subjects who died

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 24 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subject must have documented hemodynamically significant congenital heart disease (Note: Children with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus are not eligible).

    2. Subject must have unoperated or partially corrected congenital heart disease.

    3. Subject must have received at least one dose of palivizumab for prophylaxis during the Respiratory Syncytial Virus season - September 1 through April 30 (CASES), or would have been considered eligible for palivizumab prophylaxis (CONTROLS).

    4. Subject must be < 24 months of age at the time of the first dose of palivizumab prophylaxis (CASES) or < 32 months of age at the end of the assigned Respiratory Syncytial Virus season in which they would have been eligible to receive palivizumab if the drug had been approved in the European Union (CONTROLS).

    5. Subject's parent, guardian, or legal representative has voluntarily signed and dated a Release of Information Form to allow the review of medical records and collection of pertinent study data.

    Exclusion Criteria:

    1. Subject was contraindicated for treatment with palivizumab according to the current European product label.

    2. Subject had full correction of Congenital Heart Disease.

    3. Subject received palivizumab before approval for use in Congenital Heart Disease (CASES), or subject received palivizumab at any time (CONTROLS).

    4. Subject has already been included in this study in a prior Respiratory Syncytial Virus season.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 6263 Linz Austria 4020
    2 Site Reference ID/Investigator# 7956 Vienna Austria 1090
    3 Site Reference ID/Investigator# 9403 Vienna Austria 1100
    4 Site Reference ID/Investigator# 17821 Brussels Belgium 1200
    5 Site Reference ID/Investigator# 18602 Gent Belgium 9000
    6 Site Reference ID/Investigator# 18601 Leuven Belgium 3000
    7 Site Reference ID/Investigator# 6244 Nantes France 44093
    8 Site Reference ID/Investigator# 6261 Paris France 75019
    9 Site Reference ID/Investigator# 6245 Paris France CEDEX 15
    10 Site Reference ID/Investigator#6260 Reims France 51092
    11 Site Reference ID/Investigator# 6280 Bad Oeynhausen Germany 32545
    12 Site Reference ID/Investigator# 9621 Berlin Germany 10779
    13 Site Reference ID/Investigator# 16361 Braunschweig Germany 38102
    14 Site Reference ID/Investigator# 6283 Duisburg Germany 47137
    15 Site Reference ID/Investigator# 6272 Essen Germany 45147
    16 Site Reference ID/Investigator# 6271 Goettingen Germany 37075
    17 Site Reference ID/Investigator# 8277 Munich Germany 81377
    18 Site Reference ID/Investigator# 11182 Rostock Germany 18057
    19 Site Reference ID/Investigator# 6249 St. Augustin Germany 53757
    20 Site Reference ID/Investigator# 6274 Campobasso Italy 86100
    21 Site Reference ID/Investigator# 6276 Florence Italy 50139
    22 Site Reference ID/Investigator# 4703 Naples Italy 80100
    23 Site Reference ID/Investigator# 4910 Padova Italy 35128
    24 Site Reference ID/Investigator# 14681 Roma Italy 00165
    25 Site Reference ID/Investigator# 14802 Trondheim Norway 7006
    26 Site Reference ID/Investigator# 6275 Bydgoszcz Poland 85-168
    27 Site Reference ID/Investigator# 13102 Katowice Poland 40-752
    28 Site Reference ID/Investigator# 6270 Krakow Poland 3-663
    29 Site Reference ID/Investigator# 12222 Warsaw Poland 04-730
    30 Site Reference ID/Investigator# 14682 Ljubljana Slovenia 1525
    31 Site Reference ID/Investigator# 5372 A Coruna Spain 15006
    32 Site Reference ID/Investigator# 15381 Madrid Spain 28009
    33 Site Reference ID/Investigator# 15702 Madrid Spain 28034
    34 Site Reference ID/Investigator# 15261 Santiago de Compostela Spain 15706
    35 Site Reference ID/Investigator# 6282 Belfast United Kingdom BT12 6BE
    36 Site Reference ID/Investigator# 13941 Bristol United Kingdom BS2 8BJ
    37 Site Reference ID/Investigator# 5023 London United Kingdom SW3 6NP

    Sponsors and Collaborators

    • Abbott

    Investigators

    • Study Director: Andrew Campbell, MD, Medical Director, Abbott Laboratories

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01075178
    Other Study ID Numbers:
    • M03-681
    First Posted:
    Feb 25, 2010
    Last Update Posted:
    Mar 23, 2011
    Last Verified:
    Mar 1, 2011
    Keywords provided by , ,
    Infection
    Arrhythmia
    Death
    Palivizumab
    Safety
    Hemodynamically Significant Congenital Heart Disease
    Pediatric
    Observational
    Additional relevant MeSH terms:
    Respiratory Syncytial Virus Infections
    Heart Diseases
    Heart Defects, Congenital

    Study Results

    Participant Flow

    Recruitment Details Infants diagnosed with hemodynamically significant congenital heart disease who were less than 24 months of age when first dosed with palivizumab (CASES) were compared for the occurrence of serious adverse events over an 8-month chart review period with matched infants who did not receive palivizumab during the first 24 months of life (CONTROLS).
    Pre-assignment Detail
    Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
    Arm/Group Description HSCHD infants, <2 yrs old at first dose of palivizumab HSCHD infants, <2 yrs old that did not receive palivizumab
    Period Title: Subject Matching
    STARTED 1148 1421
    COMPLETED 1018 1018
    NOT COMPLETED 130 403
    Period Title: Subject Matching
    STARTED 1018 1018
    COMPLETED 1009 1009
    NOT COMPLETED 9 9

    Baseline Characteristics

    Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS) Total
    Arm/Group Description HSCHD infants, <2 yrs old at first dose of palivizumab HSCHD infants, <2 yrs old that did not receive palivizumab Total of all reporting groups
    Overall Participants 1009 1009 2018
    Age (participants) [Number]
    <=6 months
    651
    64.5%
    656
    65%
    1307
    64.8%
    >6 months
    358
    35.5%
    353
    35%
    711
    35.2%
    Age (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    5.4
    (4.91)
    5.4
    (5.05)
    5.4
    (4.98)
    Sex: Female, Male (Count of Participants)
    Female
    437
    43.3%
    462
    45.8%
    899
    44.5%
    Male
    572
    56.7%
    547
    54.2%
    1119
    55.5%
    Region of Enrollment (participants) [Number]
    France
    188
    18.6%
    211
    20.9%
    399
    19.8%
    Slovenia
    16
    1.6%
    20
    2%
    36
    1.8%
    Spain
    284
    28.1%
    170
    16.8%
    454
    22.5%
    Poland
    36
    3.6%
    242
    24%
    278
    13.8%
    Belgium
    77
    7.6%
    115
    11.4%
    192
    9.5%
    Austria
    96
    9.5%
    53
    5.3%
    149
    7.4%
    Norway
    12
    1.2%
    7
    0.7%
    19
    0.9%
    Germany
    97
    9.6%
    90
    8.9%
    187
    9.3%
    United Kingdom
    92
    9.1%
    59
    5.8%
    151
    7.5%
    Italy
    111
    11%
    42
    4.2%
    153
    7.6%
    Cardiac lesion (participants) [Number]
    Cyanotic
    488
    48.4%
    487
    48.3%
    975
    48.3%
    Acyanotic
    521
    51.6%
    522
    51.7%
    1043
    51.7%
    Corrective cardiac surgery (participants) [Number]
    None
    484
    48%
    485
    48.1%
    969
    48%
    Partially corrected congenital heart disease
    525
    52%
    521
    51.6%
    1046
    51.8%
    Fully corrected congenital heart disease
    0
    0%
    3
    0.3%
    3
    0.1%

    Outcome Measures

    1. Primary Outcome
    Title Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death
    Description The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event
    Time Frame 8-month chart review period in CASES and CONTROLS

    Outcome Measure Data

    Analysis Population Description
    The population analyzed included the full analysis set.
    Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
    Arm/Group Description HSCHD infants, <2 yrs old at first dose of palivizumab HSCHD infants, <2 yrs old that did not receive palivizumab
    Measure Participants 1009 1009
    Number [participants]
    303
    30%
    349
    34.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Palivizumab-treated Subjects (CASES), Non-palivizumab-treated Subjects (CONTROLS)
    Comments The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Observed odds ratio
    Estimated Value 0.81
    Confidence Interval (1-Sided) 95%
    to 0.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments Result provided for "95% Confidence Interval (1-Sided)" is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS).
    2. Primary Outcome
    Title Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.
    Description The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event
    Time Frame 8-month chart review period in CASES and CONTROLS

    Outcome Measure Data

    Analysis Population Description
    The population analyzed included the full analysis set.
    Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
    Arm/Group Description HSCHD infants, <2 yrs old at first dose of palivizumab HSCHD infants, <2 yrs old that did not receive palivizumab
    Measure Participants 1009 1009
    Number [participants]
    281
    27.8%
    329
    32.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Palivizumab-treated Subjects (CASES), Non-palivizumab-treated Subjects (CONTROLS)
    Comments The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Observed odds ratio
    Estimated Value 0.80
    Confidence Interval (1-Sided) 95%
    to 0.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments Result provided for "95% Confidence Interval (1-Sided)" is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS).
    3. Primary Outcome
    Title Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia
    Description The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event
    Time Frame 8-month chart review period in CASES and CONTROLS

    Outcome Measure Data

    Analysis Population Description
    The population analyzed included the full analysis set.
    Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
    Arm/Group Description HSCHD infants, <2 yrs old at first dose of palivizumab HSCHD infants, <2 yrs old that did not receive palivizumab
    Measure Participants 1009 1009
    Number [participants]
    41
    4.1%
    39
    3.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Palivizumab-treated Subjects (CASES), Non-palivizumab-treated Subjects (CONTROLS)
    Comments The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Observed odds ratio
    Estimated Value 1.05
    Confidence Interval (1-Sided) 95%
    to 1.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments Result provided for "95% Confidence Interval (1-Sided)" is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS).
    4. Primary Outcome
    Title Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death
    Description The number of subjects who died
    Time Frame 8-month chart review period in CASES and CONTROLS

    Outcome Measure Data

    Analysis Population Description
    The population analyzed included the full analysis set.
    Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
    Arm/Group Description HSCHD infants, <2 yrs old at first dose of palivizumab HSCHD infants, <2 yrs old that did not receive palivizumab
    Measure Participants 1009 1009
    Number [participants]
    9
    0.9%
    10
    1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Palivizumab-treated Subjects (CASES), Non-palivizumab-treated Subjects (CONTROLS)
    Comments The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Observed odds ratio
    Estimated Value 0.90
    Confidence Interval (1-Sided) 95%
    to 2.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments Result provided for "95% Confidence Interval (1-Sided)" is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS).

    Adverse Events

    Time Frame 8-month chart review period
    Adverse Event Reporting Description Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
    Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
    Arm/Group Description HSCHD infants, <2 yrs old at first dose of palivizumab HSCHD infants, <2 yrs old that did not receive palivizumab
    All Cause Mortality
    Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 303/1009 (30%) 349/1009 (34.6%)
    Cardiac disorders
    Arrhythmia 4/1009 (0.4%) 8/1009 (0.8%)
    Arrhythmia supraventricular 1/1009 (0.1%) 0/1009 (0%)
    Atrial fibrillation 0/1009 (0%) 1/1009 (0.1%)
    Atrial flutter 1/1009 (0.1%) 0/1009 (0%)
    Atrial tachycardia 1/1009 (0.1%) 2/1009 (0.2%)
    Atrioventricular block 4/1009 (0.4%) 3/1009 (0.3%)
    Atrioventricular block complete 1/1009 (0.1%) 4/1009 (0.4%)
    Atrioventricular block second degree 3/1009 (0.3%) 0/1009 (0%)
    Bradycardia 2/1009 (0.2%) 5/1009 (0.5%)
    Cardiac arrest 1/1009 (0.1%) 2/1009 (0.2%)
    Cardiac failure 1/1009 (0.1%) 5/1009 (0.5%)
    Extrasystoles 0/1009 (0%) 1/1009 (0.1%)
    Myocarditis 0/1009 (0%) 1/1009 (0.1%)
    Nodal arrhythmia 6/1009 (0.6%) 7/1009 (0.7%)
    Nodal rhythm 4/1009 (0.4%) 0/1009 (0%)
    Pericarditis 1/1009 (0.1%) 1/1009 (0.1%)
    Sinus arrhythmia 1/1009 (0.1%) 0/1009 (0%)
    Sinus bradycardia 0/1009 (0%) 1/1009 (0.1%)
    Sinus tachycardia 1/1009 (0.1%) 0/1009 (0%)
    Supraventricular tachycardia 10/1009 (1%) 5/1009 (0.5%)
    Tachycardia 1/1009 (0.1%) 2/1009 (0.2%)
    Ventricular tachycardia 1/1009 (0.1%) 0/1009 (0%)
    Cardiogenic shock 1/1009 (0.1%) 0/1009 (0%)
    Congestive cardiomyopathy 1/1009 (0.1%) 0/1009 (0%)
    Congenital, familial and genetic disorders
    Congenital infection 1/1009 (0.1%) 0/1009 (0%)
    Congenital pneumonia 0/1009 (0%) 1/1009 (0.1%)
    Heart disease congenital 1/1009 (0.1%) 0/1009 (0%)
    Hypoplastic left heart syndrome 1/1009 (0.1%) 0/1009 (0%)
    Eye disorders
    Conjunctivitis 0/1009 (0%) 1/1009 (0.1%)
    Gastrointestinal disorders
    Diarrhoea 0/1009 (0%) 3/1009 (0.3%)
    Dyspepsia 0/1009 (0%) 2/1009 (0.2%)
    Enterocolitis 0/1009 (0%) 4/1009 (0.4%)
    Gastritis 1/1009 (0.1%) 0/1009 (0%)
    Necrotising colitis 0/1009 (0%) 1/1009 (0.1%)
    Peritonitis 1/1009 (0.1%) 0/1009 (0%)
    Vomiting 0/1009 (0%) 1/1009 (0.1%)
    General disorders
    Pyrexia 1/1009 (0.1%) 1/1009 (0.1%)
    Hepatobiliary disorders
    Hepatitis toxic 0/1009 (0%) 1/1009 (0.1%)
    Immune system disorders
    Heart transplant rejection 1/1009 (0.1%) 0/1009 (0%)
    Infections and infestations
    Acarodermatitis 1/1009 (0.1%) 0/1009 (0%)
    Acinetobacter infection 0/1009 (0%) 1/1009 (0.1%)
    Adenovirus infection 1/1009 (0.1%) 1/1009 (0.1%)
    Anal abscess 0/1009 (0%) 1/1009 (0.1%)
    Bacillus infection 0/1009 (0%) 1/1009 (0.1%)
    Bacteraemia 5/1009 (0.5%) 0/1009 (0%)
    Bacterial infection 3/1009 (0.3%) 3/1009 (0.3%)
    Bronchiolitis 47/1009 (4.7%) 40/1009 (4%)
    Bronchitis 19/1009 (1.9%) 38/1009 (3.8%)
    Bronchitis viral 0/1009 (0%) 1/1009 (0.1%)
    Bronchopneumonia 1/1009 (0.1%) 22/1009 (2.2%)
    Candida sepsis 0/1009 (0%) 1/1009 (0.1%)
    Candidiasis 0/1009 (0%) 1/1009 (0.1%)
    Candiduria 0/1009 (0%) 1/1009 (0.1%)
    Catheter sepsis 0/1009 (0%) 1/1009 (0.1%)
    Central line infection 2/1009 (0.2%) 1/1009 (0.1%)
    Clostridial infection 0/1009 (0%) 1/1009 (0.1%)
    Croup infectious 2/1009 (0.2%) 1/1009 (0.1%)
    Dermatitis infected 0/1009 (0%) 1/1009 (0.1%)
    Ear infection 3/1009 (0.3%) 2/1009 (0.2%)
    Endocarditis 1/1009 (0.1%) 0/1009 (0%)
    Endicarditis enterococcal 0/1009 (0%) 1/1009 (0.1%)
    Enterobacter sepsis 0/1009 (0%) 1/1009 (0.1%)
    Enterocolitis infectious 1/1009 (0.1%) 0/1009 (0%)
    Exanthema subitum 0/1009 (0%) 3/1009 (0.3%)
    Eye infection 0/1009 (0%) 1/1009 (0.1%)
    Fungal infection 1/1009 (0.1%) 0/1009 (0%)
    Gastric infection 0/1009 (0%) 1/1009 (0.1%)
    Gastroenteritis 42/1009 (4.2%) 36/1009 (3.6%)
    Gastroenteritis adenovirus 1/1009 (0.1%) 0/1009 (0%)
    Gastroenteritis norovirus 8/1009 (0.8%) 0/1009 (0%)
    Gastroenteritis rotavirus 3/1009 (0.3%) 9/1009 (0.9%)
    Gastroenteritis salmonella 0/1009 (0%) 1/1009 (0.1%)
    Gastroenteritis viral 1/1009 (0.1%) 1/1009 (0.1%)
    Gastrointestinal infection 2/1009 (0.2%) 2/1009 (0.2%)
    Haemophilus infection 1/1009 (0.1%) 1/1009 (0.1%)
    Incision site abscess 1/1009 (0.1%) 0/1009 (0%)
    Infection 8/1009 (0.8%) 15/1009 (1.5%)
    Influenza 1/1009 (0.1%) 0/1009 (0%)
    Klebsiella infection 1/1009 (0.1%) 0/1009 (0%)
    Laryngitis 3/1009 (0.3%) 3/1009 (0.3%)
    Lobar pneumonia 1/1009 (0.1%) 0/1009 (0%)
    Lower respiratory tract infection 7/1009 (0.7%) 6/1009 (0.6%)
    Lower respiratory tract infection viral 1/1009 (0.1%) 0/1009 (0%)
    Lung infection 9/1009 (0.9%) 7/1009 (0.7%)
    Mediastinitis 2/1009 (0.2%) 1/1009 (0.1%)
    Meningitis 1/1009 (0.1%) 0/1009 (0%)
    Metapneumovirus infection 1/1009 (0.1%) 0/1009 (0%)
    Moraxella infection 1/1009 (0.1%) 1/1009 (0.1%)
    Nasopharyngitis 0/1009 (0%) 2/1009 (0.2%)
    Nosocomial infection 5/1009 (0.5%) 1/1009 (0.1%)
    Oral candidiasis 1/1009 (0.1%) 0/1009 (0%)
    Oral herpes 1/1009 (0.1%) 0/1009 (0%)
    Orchitis 0/1009 (0%) 1/1009 (0.1%)
    Otitis externa 0/1009 (0%) 1/1009 (0.1%)
    Otitis media 3/1009 (0.3%) 9/1009 (0.9%)
    Otitis media acute 1/1009 (0.1%) 1/1009 (0.1%)
    Parainfluenza virus infection 0/1009 (0%) 1/1009 (0.1%)
    Pharyngitis 2/1009 (0.2%) 5/1009 (0.5%)
    Pneumococcal sepsis 0/1009 (0%) 1/1009 (0.1%)
    Pneumocystitis jiroveci infection 0/1009 (0%) 1/1009 (0.1%)
    Pneumonia 30/1009 (3%) 38/1009 (3.8%)
    Pneumonia bacterial 1/1009 (0.1%) 0/1009 (0%)
    Pneumonia klebsiella 1/1009 (0.1%) 1/1009 (0.1%)
    Pneumonia respiratory syncytial viral 0/1009 (0%) 2/1009 (0.2%)
    Pneumonia streptococcal 1/1009 (0.1%) 1/1009 (0.1%)
    Pneumonia viral 1/1009 (0.1%) 0/1009 (0%)
    Post procedural infection 3/1009 (0.3%) 14/1009 (1.4%)
    Post procedural pneumonia 1/1009 (0.1%) 0/1009 (0%)
    Post procedural sepsis 0/1009 (0%) 2/1009 (0.2%)
    Postoperative wound infection 6/1009 (0.6%) 4/1009 (0.4%)
    Pseudomonas infection 3/1009 (0.3%) 3/1009 (0.3%)
    Pyelonephritis 2/1009 (0.2%) 1/1009 (0.1%)
    Respiratory syncytial virus bronchiolitis 5/1009 (0.5%) 17/1009 (1.7%)
    Respiratory syncytial virus infection 4/1009 (0.4%) 5/1009 (0.5%)
    Respiratory tract infection 19/1009 (1.9%) 19/1009 (1.9%)
    Respiratory tract infection bacterial 1/1009 (0.1%) 1/1009 (0.1%)
    Respiratory tract infection viral 3/1009 (0.3%) 2/1009 (0.2%)
    Rhinitis 2/1009 (0.2%) 2/1009 (0.2%)
    Rotavirus infection 1/1009 (0.1%) 4/1009 (0.4%)
    Sepsis 23/1009 (2.3%) 24/1009 (2.4%)
    Septic shock 0/1009 (0%) 2/1009 (0.2%)
    Serratia infection 1/1009 (0.1%) 0/1009 (0%)
    Skin infection 1/1009 (0.1%) 0/1009 (0%)
    Staphylococcal infection 2/1009 (0.2%) 3/1009 (0.3%)
    Staphylococcal sepsis 2/1009 (0.2%) 2/1009 (0.2%)
    Stenotrophomonas infection 1/1009 (0.1%) 0/1009 (0%)
    Systemic candida 1/1009 (0.1%) 0/1009 (0%)
    Tonsillitis 2/1009 (0.2%) 2/1009 (0.2%)
    Tracheitis 2/1009 (0.2%) 5/1009 (0.5%)
    Tracheobronchitis 1/1009 (0.1%) 0/1009 (0%)
    Tracheostomy infection 1/1009 (0.1%) 0/1009 (0%)
    Upper respiratory tract infection 25/1009 (2.5%) 23/1009 (2.3%)
    Urinary tract infection 31/1009 (3.1%) 36/1009 (3.6%)
    Urinary tract infection bacterial 2/1009 (0.2%) 0/1009 (0%)
    Urosepsis 1/1009 (0.1%) 0/1009 (0%)
    Varicella 2/1009 (0.2%) 1/1009 (0.1%)
    Viral infection 8/1009 (0.8%) 3/1009 (0.3%)
    Viral tonsillitis 1/1009 (0.1%) 0/1009 (0%)
    Viral upper respiratory tract infection 1/1009 (0.1%) 0/1009 (0%)
    Wound infection 5/1009 (0.5%) 3/1009 (0.3%)
    Wound infection fungal 1/1009 (0.1%) 0/1009 (0%)
    Wound infection staphylococcal 0/1009 (0%) 1/1009 (0.1%)
    Injury, poisoning and procedural complications
    Cardiac pacemaker malfunction 1/1009 (0.1%) 0/1009 (0%)
    Investigations
    Clostridium difficile toxin test 1/1009 (0.1%) 0/1009 (0%)
    Respiratory syncytial virus test positive 1/1009 (0.1%) 1/1009 (0.1%)
    Metabolism and nutrition disorders
    Dehydration 0/1009 (0%) 1/1009 (0.1%)
    Nervous system disorders
    Febrile convulsion 2/1009 (0.2%) 0/1009 (0%)
    Syncope 1/1009 (0.1%) 0/1009 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/1009 (0%) 1/1009 (0.1%)
    Lung consolidation 4/1009 (0.4%) 0/1009 (0%)
    Pneumonia aspiration 1/1009 (0.1%) 0/1009 (0%)
    Respiratory arrest 1/1009 (0.1%) 0/1009 (0%)
    Respiratory distress 1/1009 (0.1%) 0/1009 (0%)
    Pulmonary arterial hypertension 0/1009 (0%) 1/1009 (0.1%)
    Skin and subcutaneous tissue disorders
    Hangnail 0/1009 (0%) 1/1009 (0.1%)
    Vascular disorders
    Haemodynamic instability 1/1009 (0.1%) 0/1009 (0%)
    Other (Not Including Serious) Adverse Events
    Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    Only serious adverse events of infection and arrhythmia as well as deaths were collected in this study. The criterion for non-inferiority was not met for death, most likely because the reported mortality rates were lower than expected in both groups.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

    Results Point of Contact

    Name/Title Global Medical Services
    Organization Abbott
    Phone 800-633-9110
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01075178
    Other Study ID Numbers:
    • M03-681
    First Posted:
    Feb 25, 2010
    Last Update Posted:
    Mar 23, 2011
    Last Verified:
    Mar 1, 2011