Respiratory Syncytial Virus-bronchiolitisPhase 3NCT02442427
"Palivizumab Therapy for RSV-bronchiolitis"
A Phase 3 study testing Palivizumab in people with Respiratory Syncytial Virus-bronchiolitis, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
There is a growing body of literature suggesting that monoclonal antibody could be efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically insignificant adverse effects. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Respiratory Syncytial Virus-bronchiolitis
- What is being tested?
- Palivizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteQatar
- Study dates
- Sep 2014to 1 Feb 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants ≤ 3 months-old, presenting to the main pediatric ER with acute bronchiolitis associated with positive RSV rapid antigen test.
Who cannot join
- Patients will be excluded from the study if they had 1 or more of the following characteristics:
- Received monoclonal antibody or IVIG within the last 3 months prior to randomization.
- Receipt of steroids within 2 days before randomization.
- Hypersensitivity to monoclonal antibodies or immunoglobulin products.
- Immunodeficiency.
- Suspected sepsis.
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- Seizure disorders.
- Neuromuscular disorders.
- Congenital heart disease.
- Major congenital anomalies of respiratory tract.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Respiratory Syncytial Virus Bronchiolitis in Young Infants With Humanized Monoclonal Antibody: A Randomized Clinical Trial (Palivizumab Study)
There is a growing body of literature suggesting that monoclonal antibody could be efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically insignificant adverse effects.
"The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in diagnosed infants <3 months old with RSV bronchiolitis will result in fewer infants with readmissions to infirmary/observation or hospital for relapse during 3 weeks of follow-up after discharge".
Read the detailed description
Setting:
The study will be conducted between September 2014 and April 2018 in the short stay unit of the Pediatric Emergency Center (PEC) of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. The PEC serves an average of 280 000 patients annually and manages 42 beds in a short stay infirmary unit, to which patients are admitted if they are too ill to be sent home but do not need the intensive care unit. Patients admitted to the unit are assessed at least every 6 hours by a pediatrician to determine readiness for discharge. The length of stay in the unit for bronchiolitis ranges from 6 to 168 hours. In 2012, the investigators saw 8718 infants and young children in 10 666 visits for bronchiolitis. Infants aged ≤3 months presenting to the unit for treatment of viral bronchiolitis will be eligible for the study. Consecutive patients will be recruited except when a study nurse is unavailable or the unit is too busy to recruit.
Procedure:
Patients will be examined on presentation, and those needing additional treatment or observation will be admitted to the short stay infirmary unit. Consecutive patients with bronchiolitis will be assessed for study eligibility within 2 hours. Eligible patients will be enrolled after obtaining written consent. For those who consent, plain chest radiography, and nasopharyngeal swabs will be taken for RSV detection. If the patient has a positive RSV rapid antigen test, patients will be randomized to receive one of the study arms. Bronchiolitis severity score will be measured initially at the start of treatment and then at 12-hour, 24-hour, 36-hour and 48-hour thereafter. The medical team in addition to the parents and patients will be blinded to the medication delivered. Adverse effects in each group will be carefully monitored and documented. Patients will be sent home with salbutamol metered-dose inhalers with an appropriately sized Aerochamber with mask attachment. Daily follow-up by study nurse by telephone is mandatory for 1 week after discharge and then once a week for 2 weeks thereafter. The patient could return to the pediatric emergency center earlier if needed. At all revisits for the same illness, nasopharyngeal swabs will be taken for RSV rapid antigen test and the result recorded.
Study Intervention:
- Active arm: A single dose of IV palivizumab 15 mg per kilogram body weight (maximum dose =100 mg).
- Control arm: Placebo (an equivalent volume of 0.9% normal saline).
- Being tested
- Palivizumab, Placebo
- Keywords
- Respiratory syncytial virus, Palivizumab, Bronchiolitis, Treatment
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalivizumabDrug
Also called Monoclonal antibody
A single dose of IV palivizumab 15 mg per kilogram body weight (maximum dose =100 mg). The study medication will be given by IV infusion over 30 minutes using a syringe infusion pump.
PlaceboOther
Also called 0.9% Normal saline
An equal volume of 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| Palivizumab | Active comparator | A single dose of IV palivizumab Receives: Drug: Palivizumab |
| Placebo | Placebo comparator | An equivalent volume of 0.9% normal saline. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge
Measured: 3 weeks
Secondary outcomes (3)
Time to medical readiness for discharge
Measured: 4 weeks
Revisit to any medical facility for the same illness
Measured: 4 weeks
Admission to PICU during initial admission
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startSep 2014
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus-bronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Khalid Alansari, Principal investigator, Hamad Medical Corporation, Doha, Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442427
- Sponsor's protocol ID
- 14302/14
- Status last verified
- Jan 2018
- First submitted
- 10 May 2015
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Alansari K, Toaimah FH, Almatar DH, El Tatawy LA, Davidson BL, Qusad MIM. Monoclonal Antibody Treatment of RSV Bronchiolitis in Young Infants: A Randomized Trial. Pediatrics. 2019 Mar;143(3):e20182308. doi: 10.1542/peds.2018-2308. Epub 2019 Feb 13.
PubMed 30760509
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Respiratory Syncytial Virus Bronchiolitis in Young Infants With Humanized Monoclonal Antibody: A Randomized Clinical Trial (Palivizumab Study)
- ClinicalTrials.gov ID
- NCT02442427
- Acronym / sponsor ID
- 14302/14
- Keywords
- Respiratory syncytial virus, Palivizumab, Bronchiolitis, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a growing body of literature suggesting that monoclonal antibody could be efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically insignificant adverse effects.
"The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in diagnosed infants <3 months old with RSV bronchiolitis will result in fewer infants with readmissions to infirmary/observation or hospital for relapse during 3 weeks of follow-up after discharge".
Detailed description
Setting:
The study will be conducted between September 2014 and April 2018 in the short stay unit of the Pediatric Emergency Center (PEC) of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. The PEC serves an average of 280 000 patients annually and manages 42 beds in a short stay infirmary unit, to which patients are admitted if they are too ill to be sent home but do not need the intensive care unit. Patients admitted to the unit are assessed at least every 6 hours by a pediatrician to determine readiness for discharge. The length of stay in the unit for bronchiolitis ranges from 6 to 168 hours. In 2012, the investigators saw 8718 infants and young children in 10 666 visits for bronchiolitis. Infants aged ≤3 months presenting to the unit for treatment of viral bronchiolitis will be eligible for the study. Consecutive patients will be recruited except when a study nurse is unavailable or the unit is too busy to recruit.
Procedure:
Patients will be examined on presentation, and those needing additional treatment or observation will be admitted to the short stay infirmary unit. Consecutive patients with bronchiolitis will be assessed for study eligibility within 2 hours. Eligible patients will be enrolled after obtaining written consent. For those who consent, plain chest radiography, and nasopharyngeal swabs will be taken for RSV detection. If the patient has a positive RSV rapid antigen test, patients will be randomized to receive one of the study arms. Bronchiolitis severity score will be measured initially at the start of treatment and then at 12-hour, 24-hour, 36-hour and 48-hour thereafter. The medical team in addition to the parents and patients will be blinded to the medication delivered. Adverse effects in each group will be carefully monitored and documented. Patients will be sent home with salbutamol metered-dose inhalers with an appropriately sized Aerochamber with mask attachment. Daily follow-up by study nurse by telephone is mandatory for 1 week after discharge and then once a week for 2 weeks thereafter. The patient could return to the pediatric emergency center earlier if needed. At all revisits for the same illness, nasopharyngeal swabs will be taken for RSV rapid antigen test and the result recorded.
Study Intervention:
- Active arm: A single dose of IV palivizumab 15 mg per kilogram body weight (maximum dose =100 mg).
- Control arm: Placebo (an equivalent volume of 0.9% normal saline).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palivizumab | Active comparator | Drug: PalivizumabA single dose of IV palivizumab |
| Placebo | Placebo comparator | Other: PlaceboAn equivalent volume of 0.9% normal saline. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants ≤ 3 months-old, presenting to the main pediatric ER with acute bronchiolitis associated with positive RSV rapid antigen test.
Key exclusion criteria (10 listed)
- Patients will be excluded from the study if they had 1 or more of the following characteristics:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalivizumabAlso: Monoclonal antibodyA single dose of IV palivizumab 15 mg per kilogram body weight (maximum dose =100 mg). The study medication will be given by IV infusion over 30 minutes using a syringe infusion pump. | Drug | Palivizumab |
| PlaceboAlso: 0.9% Normal salineAn equal volume of 0.9% normal saline | Other | Placebo |
Primary outcome
Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge
Time frame: 3 weeks
3 secondary outcomes
Time to medical readiness for discharge
Time frame: 4 weeks
Revisit to any medical facility for the same illness
Time frame: 4 weeks
Admission to PICU during initial admission
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Derived from this study: PubMed 30760509Alansari K, Toaimah FH, Almatar DH, El Tatawy LA, Davidson BL, Qusad MIM. Monoclonal Antibody Treatment of RSV Bronchiolitis in Young Infants: A Randomized Trial. Pediatrics. 2019 Mar;143(3):e20182308. doi: 10.1542/peds.2018-2308. Epub 2019 Feb 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Khalid Alansari principal investigator
Hamad Medical Corporation, Doha, Qatar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palivizumab in people with Respiratory Syncytial Virus-bronchiolitis, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02442427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.