INSPIRA: Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01107535
• Collaborator: (none)
• Enrollment: 82
• Locations: 4
• Duration (Months): 41
• Patients Per Site: 20.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Published data by the Organización panamericana de la Salud shows that Peru's mortality rate from acute respiratory infections (ARI) in infants less than one year of life is second only to Haiti (14,150/100,000). Government data reports shows a marked increase of RSV infections in Peru. "Instituto Nacional de Salud" (Peru's National Institute of Health) reports between January 1st to February 26th 2006, 62% of their positive samples corresponded to RSV. Epidemiological data from Lima-Peru, demonstrates that there is no specific season for RSV infection although some data suggest an increase in RSV activity during cold months (May to September; INS data). Clinical studies show that giving five doses of Synagis (palivizumab) resulted in serum concentrations > 30 ug/mL for >20 weeks. The aim of this post-marketing observational study is to determine the RSV hospitalization rate in high-risk infants who received Synagis (palivizumab) through the Social Security Hospitals in the context of routine clinical practice.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infection	Biological: Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.

Study Design

• Study Type: Observational
• Actual Enrollment: 82 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Study of the Effectiveness of Synagis Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus Infection
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Infants receiving Synagis (palivizumab) immunoprophylaxis Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.

Biological: Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.; Synagis (palivizumab) administered according to usual clinical practice. After the enrollment visit, subjects will have monthly visits until they have received the complete Synagis immunization regimen of their hospital, then they will have 2 follow up visits, one of them 30 days after the fifth dose of Synagis and the other visit at one year of age.; Other Names: palivizumab Synagis

Outcome Measures

Primary Outcome Measures

1. Number of Hospital Admissions by Respiratory Syncytial Virus Infection [First year of life (up to 12 months)]

   The number of participants hospitalized for respiratory syncytial virus infection from the first dose of study drug up to the visit coinciding with the first birthday of the participant. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.

Secondary Outcome Measures

1. Number of Hospital Admission Days (All Causes) [Hospital admission to hospital discharge]

   The mean (average) number days participants were hospitalized.

2. Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection [Hospital admission to hospital discharge]

   The number of days spent in a hospital intensive care unit (ICU) are summarized for those participants requiring that type of care. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.

3. Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission [Hospital admission to hospital discharge]

   The mean (average) number of days participants required supplemental oxygen during any hospital stay and the mean number of days participants required mechanical ventilation while in the intensive care unit.

4. Number of Serious Adverse Events [Enrollment until 100 days after the last Synagis (palivizumab) dose]

   The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Receiving Synagis (palivizumab) immunoprophylaxis during respiratory syncytial virus season, according to the usual clinical practice:

• Infants born < or = 32 weeks of gestation and are younger than 6 months of age at the beginning of the respiratory syncytial virus season.

• Children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months, until the first year of life.

• Children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment).

Exclusion Criteria:

• Major congenital malformation aside from congenital heart disease

• Chronic pulmonary disease other than bronchopulmonary dysplasia

• Active infections

• Contraindication to Synagis

• Receipt of another immunoglobulin preparation including but not restricted to polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin (Cytogam), or respiratory syncytial virus hyperimmunoglobulin (Respigam).

• Any other condition that according deemed an obstacle for study conduction or representing an unacceptable risk by the participating investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 27834	Arequipa		Peru
2	Site Reference ID/Investigator# 6059	Callao		Peru	2
3	Site Reference ID/Investigator# 27836	Lima		Peru	01
4	Site Reference ID/Investigator# 27835	Lima		Peru	27

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Oscar Guerra, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT01107535
• Other Study ID Numbers: PMOS-PERU 07-01
• First Posted: Apr 21, 2010
• Last Update Posted: Oct 31, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Abbott: Synagis (palivizumab) immunoprophylaxis; Respiratory syncytial virus infection; Preterm infants
• Additional relevant MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections; Palivizumab; Antibodies; Antibodies, Monoclonal

Study Results

Participant Flow

Arm/Group Title	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Arm/Group Description	Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Period Title: Overall Study
STARTED	82
Number of Participants Analyzed	82
COMPLETED	77
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Arm/Group Description	Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Overall Participants	82
Age (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	68 (63)
Sex: Female, Male (Count of Participants)
Female	40 48.8%
Male	42 51.2%
Region of Enrollment (participants) [Number]
Peru	82 100%
Gestational age (participants) [Number]
Gestational age less than 28 weeks	22 26.8%
Gestational age >28 weeks and <32 weeks	60 73.2%

Outcome Measures

1. Primary Outcome

Title	Number of Hospital Admissions by Respiratory Syncytial Virus Infection
Description	The number of participants hospitalized for respiratory syncytial virus infection from the first dose of study drug up to the visit coinciding with the first birthday of the participant. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.
Time Frame	First year of life (up to 12 months)

Outcome Measure Data

Analysis Population Description

Analysis included all enrolled participants.

Arm/Group Title	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Arm/Group Description	Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Measure Participants	82
Number [participants]	2 2.4%

2. Secondary Outcome

Title	Number of Hospital Admission Days (All Causes)
Description	The mean (average) number days participants were hospitalized.
Time Frame	Hospital admission to hospital discharge

Outcome Measure Data

Analysis Population Description

Analysis included all participants who were hospitalized during the study. This includes 2 participants hospitalized due to respiratory syncytial virus infection and 8 participants hospitalized for other respiratory diseases.

Arm/Group Title	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Arm/Group Description	Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Measure Participants	10
Mean (Standard Deviation) [days]	18.4 (29.7)

3. Secondary Outcome

Title	Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection
Description	The number of days spent in a hospital intensive care unit (ICU) are summarized for those participants requiring that type of care. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.
Time Frame	Hospital admission to hospital discharge

Outcome Measure Data

Analysis Population Description

Two participants with a total of 3 intensive care unit stays were analyzed. One participant was negative for respiratory syncytial virus during their first stay in the intensive care unit and was positive for respiratory syncytial virus at their second stay.

Arm/Group Title	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Arm/Group Description	Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Measure Participants	2
ICU stay length (n=1, RSV negative)	5
ICU stay length (n=1, Stay #1 of 2, RSV negative)	10
ICU stay length (n=1, Stay #2 of 2, RSV positive)	106

4. Secondary Outcome

Title	Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission
Description	The mean (average) number of days participants required supplemental oxygen during any hospital stay and the mean number of days participants required mechanical ventilation while in the intensive care unit.
Time Frame	Hospital admission to hospital discharge

Outcome Measure Data

Analysis Population Description

Analysis of supplemental oxygen included participants with any hospital stay during the study (n=10) and analysis of mechanical ventilation included the subgroup of participants with intensive care unit stays during the study (n=2).

Arm/Group Title	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Arm/Group Description	Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Measure Participants	10
Supplemental oxygen (n=10)	17 (32)
Mechanical ventilation (n=2)	36.7 (49)

5. Secondary Outcome

Title	Number of Serious Adverse Events
Description	The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.
Time Frame	Enrollment until 100 days after the last Synagis (palivizumab) dose

Outcome Measure Data

Analysis Population Description

Analysis included all enrolled participants.

Arm/Group Title	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Arm/Group Description	Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Measure Participants	82
Number [participants]	11 13.4%

Adverse Events

Time Frame	Adverse events were assessed throughout the study observation period until 100 days after the last dose of Synagis. Participants were followed for an average of 12.4 months.
Arm/Group Title	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Arm/Group Description	Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
All Cause Mortality
	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
	Affected / at Risk (%)	# Events
Total	11/82 (13.4%)
Cardiac disorders
Cardio-respiratory arrest	1/82 (1.2%)	1
Eye disorders
Retinopathy of immaturity	1/82 (1.2%)	1
Gastrointestinal disorders
Intussusception	1/82 (1.2%)	1
General disorders
Sudden infant death syndrome	1/82 (1.2%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	4/82 (4.9%)	4
Atelectasis neonatal	1/82 (1.2%)	1
Bronchopulmonary dysplasia	1/82 (1.2%)	1
Bronchial obstruction	2/82 (2.4%)	2
Respiratory syncytial virus infection	1/82 (1.2%)	1
Upper respiratory tract infection	1/82 (1.2%)	1
Apnea	1/82 (1.2%)	1
Other (Not Including Serious) Adverse Events
	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
	Affected / at Risk (%)	# Events
Total	17/82 (20.7%)
Infections and infestations
Diarrhoea infectious	2/82 (2.4%)	2
Respiratory, thoracic and mediastinal disorders
Pharyngitis	7/82 (8.5%)	8
Bronchial obstruction	5/82 (6.1%)	8
Pneumonia	1/82 (1.2%)	1
Bronchiolitis	1/82 (1.2%)	1
Nasopharyngitis	2/82 (2.4%)	3
Tracheobronchitis	1/82 (1.2%)	1
Skin and subcutaneous tissue disorders
Urticaria	1/82 (1.2%)	1

Limitations/Caveats

[Not Specified]

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.