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New RSV prevention strategy for infants under study in bogotá

NCT ID NCT07279298

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study will check how well two RSV prevention methods work in real life: a vaccine given to pregnant women and an antibody shot given to newborns. Researchers will follow about 1,100 infants under 6 months old who are hospitalized with severe respiratory infections in Bogotá, Colombia. The goal is to see if these immunizations reduce severe RSV cases and hospital stays.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RSVpreF vaccine (Abrysvo) and nirsevimab (Beyfortus)
What this could lead to
If effective, these immunizations could prevent severe RSV infections in young infants, reducing hospitalizations and deaths.
What could go wrong
This is an observational study, not a controlled trial, so results may be less certain. Effectiveness may vary in real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,097 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Infants younger than six months residing in Bogotá, Colombia, hospitalized for severe acute respiratory infection in sentinel hospitals and tested for RSV within 48 hours of admission. The population includes infants exposed to maternal RSVpreF vaccination, neonatal nirsevimab, or neither intervention. Extremely preterm infants (≤32 weeks gestation) and those hospitalized for non-respiratory conditions are excluded.

Ages

1 day to 180 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age: Infants younger than 6 months at the time of hospital admission. * Residence: Maternal residence in Bogotá, Colombia, verified through clinical record, identification document, or health system registry. * Clinical Condition: Hospitalization due to severe acute respiratory infection (SARI) meeting the district operational definition (presence of fever, cough, and/or signs of respiratory distress, requiring inpatient management). * Laboratory Testing: Respiratory specimen collected and tested for RSV by RT-PCR or validated antigen test within ≤48 hours of hospital admission, or repeated within 24-48 hours if initial test is negative. * Exposure Eligibility Window: Infant born ≥5 weeks after the start of the RSVpreF maternal vaccination campaign in Bogotá, ensuring opportunity for maternal immunization. Exclusion Criteria: * Prematurity: Infants born at ≤32 weeks of gestation. * Healthcare-associated respiratory infection: Symptom onset \>48 hours after hospital admission for another condition. * Non-respiratory hospital admission: Primary reason for hospitalization unrelated to respiratory disease (e.g., trauma, elective surgery). * Vaccination status unverifiable: Inability to confirm maternal RSVpreF vaccination status after reasonable attempts to verify through registry, vaccination card, or prenatal documentation. * Duplicate episodes: Readmission for the same respiratory episode ≤14 days after discharge (only the first episode will be included). * Delayed sampling: First respiratory sample obtained \>48-72 hours after initial admission to the health system. * Lethal congenital conditions: Congenital or genetic disorders incompatible with life or that substantially alter the expected clinical course. * Concurrent interventional study participation: Enrollment in another clinical trial that may affect respiratory outcomes. * Inability to establish mother-infant linkage due to adoption, loss of parental custody, or absence of biological maternal records.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Secretaria distrital de Salud

    Bogotá, Colombia

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