SUNRISE: Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02282982
• Collaborator: (none)
• Enrollment: 359
• Duration (Months): 7

Study Details

Study Description

Brief Summary

This was a non-interventional, prospective, multi-center study with no control group designed to assess the effectiveness of palivizumab in a population of infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)). Participants received immunoprophylaxis during the RSV season, defined as October 2014 through April 2015, in routine clinical settings throughout the Russian Federation.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus (RSV)

Detailed Description

Participants received intramuscular injections of palivizumab according to physicians' prescription and the local label. The local label recommended 1 month injection intervals between 5 sequential injections at a dose of 15 mg/kg. Participants could have received from 3 to 5 monthly injections of palivizumab during the 2014 - 2015 RSV season and the duration of this study.

Study Design

• Study Type: Observational
• Actual Enrollment: 359 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective, Multi-Center, Observational Program to Assess RSV Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis in Routine Clinical Setting in the Russian Federation
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Infants at high-risk of serious RSV illness Infants who received immunoprophylaxis during the RSV season

Outcome Measures

Primary Outcome Measures

1. Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test [Approximately 7 months]

   Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.

2. Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection [Approximately 7 months]

   Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.

Secondary Outcome Measures

1. Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test [Approximately 7 months]

   The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.

2. Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants [Approximately 7 months]

   The number of hospitalized participants admitted to the Intensive Care Unit was documented.

3. Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU) [Approximately 7 months]

   The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.

4. Proportion of Participants Who Received Supplemental Oxygen While Hospitalized [Approximately 7 months]

   The proportion of participants who received supplemental oxygen while hospitalized was documented.

5. Proportion of Participants Who Received Mechanical Ventilation While Hospitalized [Approximately 7 months]

   The proportion of participants who received mechanical ventilation while hospitalized was documented.

6. Proportion of Participants With Missed Doses of Palivizumab [Approximately 7 months]

   The proportion of participants with missed or delayed doses of palivizumab was documented.

7. Proportion of Participants With Co-morbidities During Hospitalizations [Approximately 7 months]

   The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).

8. Median Duration of Mechanical Ventilation Administration During Hospitalizations [Approximately 7 months]

   The median duration of mechanical ventilation administration during hospitalizations was calculated.

9. Median Duration of Oxygen Administration During Hospitalizations [Approximately 7 months]

   The median duration of mechanical oxygen administration during hospitalizations was calculated.

10. Proportion of Participants With a Particular Co-morbidity [Approximately 7 months]

    The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 2 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Planned prescription of palivizumab for immunoprophylaxis during RSV season or participants for whom palivizumab was prescribed and who received the first dose of palivizumab no later than 60 days before enrollment in the study

• Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:

• Infants born ≤35 weeks gestational age AND are ≤6 months of age at the onset of the RSV season;

• Infants ≤24 months of age AND with a diagnosis of BPD (defined as oxygen requirement at a corrected gestational age of 36 weeks);

• Infants ≤24 months of age with hemodynamically significant CHD, unoperated or partially corrected.

• Written authorization to use individual data signed by parents or child representative

Exclusion Criteria:

• Major congenital malformation aside from CHD

• Chronic pulmonary disease other than BPD

• Acute period of any infection

• Contraindication to palivizumab prescription according to local label

• Administration of a product possibly containing RSV-neutralizing antibody within 30 days prior to enrollment or current administration (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Andrey Strugovschikov, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02282982
• Other Study ID Numbers: P14-579
• First Posted: Nov 5, 2014
• Last Update Posted: Jul 29, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by AbbVie: Immunoprophylaxis; Palivizumab

Study Results

Participant Flow

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Period Title: Overall Study
STARTED	359
Attended Visit 1	359
Attended Visit 2	341
Attended Visit 3	298
Attended Visit 4	194
Attended Visit 5	83
Attended Follow-up Visit	349
COMPLETED	153
NOT COMPLETED	206

Baseline Characteristics

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Overall Participants	359
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	3.4 (3.6)
Sex: Female, Male (Count of Participants)
Female	179 49.9%
Male	180 50.1%

Outcome Measures

1. Primary Outcome

Title	Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test
Description	Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Infants who received immunoprophylaxis during the RSV season

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	359
Number [participants]	1 0.3%

2. Primary Outcome

Title	Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection
Description	Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Infants who received immunoprophylaxis during the RSV season

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	359
Number [participants]	0 0%

3. Secondary Outcome

Title	Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test
Description	The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	1
Median (Full Range) [days]	46

4. Secondary Outcome

Title	Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants
Description	The number of hospitalized participants admitted to the Intensive Care Unit was documented.
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	1
Number [participants]	1 0.3%

5. Secondary Outcome

Title	Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)
Description	The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	1
Median (Full Range) [days]	35

6. Secondary Outcome

Title	Proportion of Participants Who Received Supplemental Oxygen While Hospitalized
Description	The proportion of participants who received supplemental oxygen while hospitalized was documented.
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	1
Number [participants]	1 0.3%

7. Secondary Outcome

Title	Proportion of Participants Who Received Mechanical Ventilation While Hospitalized
Description	The proportion of participants who received mechanical ventilation while hospitalized was documented.
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	1
Number [participants]	0 0%

8. Secondary Outcome

Title	Proportion of Participants With Missed Doses of Palivizumab
Description	The proportion of participants with missed or delayed doses of palivizumab was documented.
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Infants who received immunoprophylaxis during the RSV season

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	359
1 missed or delayed injection	61 17%
2 or more missed or delayed injections	20 5.6%

9. Secondary Outcome

Title	Proportion of Participants With Co-morbidities During Hospitalizations
Description	The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	1
Number [participants]	1 0.3%

10. Secondary Outcome

Title	Median Duration of Mechanical Ventilation Administration During Hospitalizations
Description	The median duration of mechanical ventilation administration during hospitalizations was calculated.
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	1
Median (Full Range) [days]	0

11. Secondary Outcome

Title	Median Duration of Oxygen Administration During Hospitalizations
Description	The median duration of mechanical oxygen administration during hospitalizations was calculated.
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	1
Median (Full Range) [days]	30

12. Secondary Outcome

Title	Proportion of Participants With a Particular Co-morbidity
Description	The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).
Time Frame	Approximately 7 months

Outcome Measure Data

Analysis Population Description

Infants who received immunoprophylaxis during the RSV season

Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
Measure Participants	359
History of bronchopulmonary dysplasia	148 41.2%
History of congenital heart disease	45 12.5%

Adverse Events

Time Frame	Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks.
Adverse Event Reporting Description	Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Arm/Group Title	Infants at High-risk of Serious RSV Illness
Arm/Group Description	Infants who received immunoprophylaxis during the RSV season
All Cause Mortality
	Infants at High-risk of Serious RSV Illness
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Infants at High-risk of Serious RSV Illness
	Affected / at Risk (%)	# Events
Total	17/359 (4.7%)
Blood and lymphatic system disorders
Anaemia	1/359 (0.3%)
Haemorrhagic disorder	1/359 (0.3%)
Cardiac disorders
Myocarditis	1/359 (0.3%)
Pericardial effusion	1/359 (0.3%)
Gastrointestinal disorders
Ascites	1/359 (0.3%)
Enterocolitis	1/359 (0.3%)
Intestinal obstruction	1/359 (0.3%)
Pancreatitis necrotising	1/359 (0.3%)
Hepatobiliary disorders
Hepatitis	1/359 (0.3%)
Infections and infestations
Respiratory tract infection viral	6/359 (1.7%)
Bronchitis	5/359 (1.4%)
Pneumonia	5/359 (1.4%)
Bronchopneumonia	2/359 (0.6%)
Otitis media acute	2/359 (0.6%)
Pyelonephritis acute	2/359 (0.6%)
Bacteraemia	1/359 (0.3%)
Conjunctivitis	1/359 (0.3%)
Infection	1/359 (0.3%)
Meningitis	1/359 (0.3%)
Osteomyelitis	1/359 (0.3%)
Viral infection	1/359 (0.3%)
Metabolism and nutrition disorders
Decreased appetite	1/359 (0.3%)
Musculoskeletal and connective tissue disorders
Connective tissue disorder	1/359 (0.3%)
Nervous system disorders
Brain oedema	1/359 (0.3%)
Hydrocephalus	1/359 (0.3%)
Hypoxic-ischaemic encephalopathy	1/359 (0.3%)
Lethargy	1/359 (0.3%)
Periventricular leukomalacia	1/359 (0.3%)
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia	2/359 (0.6%)
Cough	1/359 (0.3%)
Dyspnoea	1/359 (0.3%)
Hydrothorax	1/359 (0.3%)
Pulmonary oedema	1/359 (0.3%)
Other (Not Including Serious) Adverse Events
	Infants at High-risk of Serious RSV Illness
	Affected / at Risk (%)	# Events
Total	0/359 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.