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New treatment option for Respiratory Syncytial Virus (RSV)
Official title Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
ClinicalTrials.gov ID: NCT06851806
What this study is testing
What is Palivizumab 15 mg/kg?
Palivizumab 15 mg/kg is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for respiratory syncytial virus (rsv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase IV, prospective, open-label, multicentre study to evaluate the safety of palivizumab IM injection for the prevention of severe LRTD in Indian infants and children who are at high-risk of RSV disease. All enrolled participants will receive palivizumab 15 mg/kg IM injection once a month for up to 5 injections during the study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Participants at risk of severe RSV disease defined as fulfilling at least one of the following:
- Infants born ≤ 35 wGA and are \< 6 months of age at enrolment.
- Children \< 24 months of age at enrolment and requiring treatment for BPD within the last 6 months.
- Children \< 24 months of age and with haemodynamically significant CHD.
- Written informed consent obtained from the participant's parent(s)/legal guardian and the participant's parent(s)/legal guardian is able to...
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Hospitalisation at the time of enrolment, unless the discharge is expected within 30 days of the time of enrolment
- Required mechanical ventilation (including continuous positive airway pressure) or other mechanical respiratory or cardiac support at the time of...
- Anticipated cardiac surgery within 2 weeks after enrolment.
- Anticipated survival of \< 6 months after enrolment in the trial.
- Active LRTD, including RSV infection at the time of enrolment and/or study intervention administration.
See the full eligibility criteria
- Participants at risk of severe RSV disease defined as fulfilling at least one of the following:
- Infants born ≤ 35 wGA and are \< 6 months of age at enrolment.
- Children \< 24 months of age at enrolment and requiring treatment for BPD within the last 6 months.
- Children \< 24 months of age and with haemodynamically significant CHD.
- Written informed consent obtained from the participant's parent(s)/legal guardian and the participant's parent(s)/legal guardian is able to understand and comply with the requirements of the protocol including follow-up...
- Participants are excluded from the study if any of the following criteria apply:
- Hospitalisation at the time of enrolment, unless the discharge is expected within 30 days of the time of enrolment
- Required mechanical ventilation (including continuous positive airway pressure) or other mechanical respiratory or cardiac support at the time of enrolment.
- Anticipated cardiac surgery within 2 weeks after enrolment.
- Anticipated survival of \< 6 months after enrolment in the trial.
- Active LRTD, including RSV infection at the time of enrolment and/or study intervention administration.
- Any fever (≥ 38.0°C) or acute illness within 7 days prior to investigational product administration.
- Known history of evolving or unstable neurologic disorder.
- Known history of unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated.
- Known allergy, including to immunoglobulin products, or history of allergic reaction.
- Receipt of palivizumab or other RSV monoclonal antibodies or any RSV vaccine, including maternal RSV vaccination.
- Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study.
- Concurrent enrolment in another treatment study.
- Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- Judgment by the investigator that the participant should not participate in the study if the participant or the participant's parent/legal guardian is unlikely to comply with study procedures, restrictions, and...
The study team makes the final eligibility decision.
Where it's taking place
- Hyderabad, India
- Kanpur, India
- Kolkata, India
- Mysore, India
- Pune, India
- Vidyanagar, Hubballi, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hyderabad, India; Kanpur, India; Kolkata, India; Mysore, India; Pune, India; Vidyanagar, Hubballi, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.