Respiratory Tract Infections (RTI)MINERVALNCT07249996
Respiratory Infections in Young Children
An observational study of Respiratory Tract Infections (RTI) and Lower Respiratory Tract Infection (LRTI), run by Eduardo Lopez -Medina at 2 sites in 2 countries.
Trial summary
The goal of this observational study is to learn about the causes, severity, and long-term effects of respiratory tract infections (RTIs) in young children from birth to five years of age in Colombia and Panamá. Read more about this study
- Who is it for?
- Ages Up to 29 daysHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections (RTI), Lower Respiratory Tract Infection (LRTI), Viral Infections
- How many people
- 1,088 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 May 2024to 30 Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 29 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborns younger than 29 days of life, with or without pre-existing conditions
Who may be able to join
- Newborns younger than 29 days of life, with or without pre-existing conditions
- Infants whose parent(s) or guardian(s) are available for telephone contact for the duration of the study, and do not intend to relocate outside of the study area, to ensure adherence to RTI and in-person visits.
- Infants whose parent(s) or guardian(s) provide informed consent to participate in the study.
- Infants whose parent(s) or guardian(s) are willing to authorize data and specimen collection, storage and analysis.
Who cannot join
- Infants born to a pregnant mother under 14 years of age (under Colombian law, pregnancies occurring in individuals younger than 14 years of age are legally presumed to result from sexual abuse).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Colombia1 site, 1 recruiting
- Recruiting
Centro de Estudios en Infectologia Pediatrica, CEIP
Cali, Valle del Cauca Department
Diana Maria Davalos, MD, MPH, DrPH, +573156129274, diana.davalos@ceiponline.org
Panama1 site, 1 recruiting
- Recruiting
Cevaxin
Panama City
Gabrielle Britton, PhD, +5072039360, gabrielle.britton@cevaxin.com
About this study
Official title: Respiratory Infections in Young Children in Colombia and Panamá: Epidemiology, Interactions, and Long-term Consequences.
The goal of this observational study is to learn about the causes, severity, and long-term effects of respiratory tract infections (RTIs) in young children from birth to five years of age in Colombia and Panamá. The main questions it aims to answer are:
How often do respiratory infections occur in children under two years old, and which viruses or bacteria cause them? Why do some children develop more severe infections than others? Do early infections or vaccinations change how the immune system responds to future illnesses? How do viruses and bacteria interact in the respiratory tract to influence disease severity and long-term respiratory health? Researchers will follow newborns from birth until age five to understand how respiratory infections develop and affect children's health over time. Participants will not receive any experimental treatment.
Read more
Families who join the study will:
Be contacted twice a week through a phone app or phone calls to check for symptoms of respiratory infection.
Attend in-person visits if their child becomes ill and every six months for routine follow-up.
Provide nasal and blood samples during illness episodes so researchers can identify the viruses or bacteria causing infection and study how the immune system responds.
This study began in May 2024 and is being conducted in Cali, Colombia, and Panamá City, Panamá. The research team plans to continue to include participants and continue active follow-up until the children reach five years of age.
The information collected will help scientists and health professionals understand how different pathogens cause respiratory infections, what factors increase the risk of severe illness, and how early infections may influence long-term lung health. The study's findings will support future efforts to prevent and treat respiratory diseases in young children.
Read the detailed description
Respiratory tract infections (RTIs) remain one of the most common causes of illness and death in young children, despite advances in vaccination and health programs. In children under five years of age, RTIs cause significant morbidity, social costs, and long-term health consequences. The clinical spectrum of RTI ranges from mild upper infections to severe lower respiratory tract infections (LRTIs) such as bronchiolitis and pneumonia. Viruses are the leading cause, especially in the first two years of life. However, in Latin America, there is limited information about how often RTIs occur, what viruses or bacteria are responsible, and how severe these infections are in community settings. Most existing data come from hospitalized cases, which underestimate the real disease burden.
To address this gap, researchers launched the MINERVAL study, a multicenter, prospective birth cohort conducted in Cali, Colombia, and Panamá City, Panamá. The study began in May 2024 and follows children from birth to five years of age to better understand the epidemiology, etiology, and consequences of RTIs. A total of 436 newborns have been enrolled as of February 2025. This population-based cohort is followed by active surveillance twice a week using a phone app or calls, with in-person visits during RTI episodes and routine visits every six months in the first two years of life. From ages two to five, children continue follow-up every six months to assess long-term outcomes.
The study has four main objectives: (1) to determine the incidence, etiology, and seasonality of RTIs in children aged 0-2 years; (2) to assess the pathogen-specific burden of infections caused by viruses such as RSV, hMPV, influenza, SARS-CoV-2, and others across outpatient and inpatient settings; (3) to evaluate long-term respiratory sequelae of LRTIs during early life and their association with chronic respiratory illness by age five; and (4) to analyze viral-bacterial interactions, focusing on how pneumococcal bacterial loads and immune responses influence disease progression.
Preliminary data from 436 participants show 222 RTI episodes, including 42 LRTIs. The cumulative incidence of RTI was 40% at 100 days and 64.8% at 250 days. For LRTIs, incidence was 8.9% at 100 days and 12.2% at 250 days. Among LRTIs, 82.9% were mild, 14.6% moderate, and 2.4% severe. More than half of LRTI episodes required hospitalization, and 14.3% required intensive care. Samples have been collected from 91% of episodes for laboratory analysis.
These findings confirm the feasibility of long-term active surveillance in this cohort and the high frequency of early-life respiratory infections. The continued study will provide critical insights into the incidence, mechanisms, and long-term health consequences of RTIs in Latin American children, supporting the development of new preventive and therapeutic strategies.
- Conditions
- Respiratory Tract Infections (RTI), Lower Respiratory Tract Infection (LRTI), Viral Infections, Cohort Study
- Keywords
- Birth Cohort Study, Respiratory Tract Infection (RTI), Children
- Medical subject headings
- Respiratory Tract Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| • Newborns younger than 29 days of life, with or without pre-existing conditions | Infants whose parent(s) or guardian(s) are available for telephone contact for the duration of the study, do not intend to relocate outside of the study area, provide informed consent to participate in the study and are willing to authorize data and specimen collection, storage and analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate
The number and etiology of new cases of RTI and LRTI according to cumulative time at risk and month of occurrence, in children aged 0 to 2 years.
Measured: From enrollment, up to 2 years of age.
Secondary outcomes (3)
Severity by pathogen
Frequency of children who develop RTI, and mild, moderate or severe LRTI, according to pathogen and maximum level of care (outpatient care, emergency room, hospital admission or intensive care) and oxygen support (none, nasal canula, non-invasive ventilation or mechanical ventilation) received by children with LRTI, according to pathogen
Measured: From enrollment, up to 2 years of age
Burden in in-patient and outpatient settings
Median Duration of symptoms, Hospitalization rates, Length of hospital stay, Use of medications, Antibiotic consumption, Lost workdays and daily activities due to illness
Measured: From recruitment, up to 2 years of age
Pneumococcal bacterial load and Host immune response
Disease severity according to pneumococcal bacterial loads and whole blood transcriptome analysis.
Measured: From recruitment, up to 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start2 May 2024
- Primary completion2 May 2031 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract Infections (RTI)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,088 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Eduardo Lopez -Medina
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Eduardo Lopez -Medina, Centro de Estudios en Infectogía Pediatrica
- Investigators
- Eduardo Lopez-Medina, MD, MSc, Principal investigator, Centro de Estudios en Infectologia Pediatrica, CEIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249996
- Sponsor's protocol ID
- 103600
- Acronym
- MINERVAL
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Infections in Young Children in Colombia and Panamá: Epidemiology, Interactions, and Long-term Consequences.
- ClinicalTrials.gov ID
- NCT07249996
- Acronym / sponsor ID
- MINERVAL / 103600
- Conditions
- Respiratory Tract Infections (RTI), Lower Respiratory Tract Infection (LRTI), Viral Infections, Cohort Study
- Keywords
- Birth Cohort Study, Respiratory Tract Infection (RTI), Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,088 participants (estimated)
- Lead sponsor
- Eduardo Lopez -MedinaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 2 May 2024 (actual)
- Primary completion
- 2 May 2031 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 25 Nov 2025 (actual)
- 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.
The goal of this observational study is to learn about the causes, severity, and long-term effects of respiratory tract infections (RTIs) in young children from birth to five years of age in Colombia and Panamá. The main questions it aims to answer are:
How often do respiratory infections occur in children under two years old, and which viruses or bacteria cause them? Why do some children develop more severe infections than others? Do early infections or vaccinations change how the immune system responds to future illnesses? How do viruses and bacteria interact in the respiratory tract to influence disease severity and long-term respiratory health? Researchers will follow newborns from birth until age five to understand how respiratory infections develop and affect children's health over time. Participants will not receive any experimental treatment.
Families who join the study will:
Be contacted twice a week through a phone app or phone calls to check for symptoms of respiratory infection.
Attend in-person visits if their child becomes ill and every six months for routine follow-up.
Provide nasal and blood samples during illness episodes so researchers can identify the viruses or bacteria causing infection and study how the immune system responds.
This study began in May 2024 and is being conducted in Cali, Colombia, and Panamá City, Panamá. The research team plans to continue to include participants and continue active follow-up until the children reach five years of age.
The information collected will help scientists and health professionals understand how different pathogens cause respiratory infections, what factors increase the risk of severe illness, and how early infections may influence long-term lung health. The study's findings will support future efforts to prevent and treat respiratory diseases in young children.
Detailed description
Respiratory tract infections (RTIs) remain one of the most common causes of illness and death in young children, despite advances in vaccination and health programs. In children under five years of age, RTIs cause significant morbidity, social costs, and long-term health consequences. The clinical spectrum of RTI ranges from mild upper infections to severe lower respiratory tract infections (LRTIs) such as bronchiolitis and pneumonia. Viruses are the leading cause, especially in the first two years of life. However, in Latin America, there is limited information about how often RTIs occur, what viruses or bacteria are responsible, and how severe these infections are in community settings. Most existing data come from hospitalized cases, which underestimate the real disease burden.
To address this gap, researchers launched the MINERVAL study, a multicenter, prospective birth cohort conducted in Cali, Colombia, and Panamá City, Panamá. The study began in May 2024 and follows children from birth to five years of age to better understand the epidemiology, etiology, and consequences of RTIs. A total of 436 newborns have been enrolled as of February 2025. This population-based cohort is followed by active surveillance twice a week using a phone app or calls, with in-person visits during RTI episodes and routine visits every six months in the first two years of life. From ages two to five, children continue follow-up every six months to assess long-term outcomes.
The study has four main objectives: (1) to determine the incidence, etiology, and seasonality of RTIs in children aged 0-2 years; (2) to assess the pathogen-specific burden of infections caused by viruses such as RSV, hMPV, influenza, SARS-CoV-2, and others across outpatient and inpatient settings; (3) to evaluate long-term respiratory sequelae of LRTIs during early life and their association with chronic respiratory illness by age five; and (4) to analyze viral-bacterial interactions, focusing on how pneumococcal bacterial loads and immune responses influence disease progression.
Preliminary data from 436 participants show 222 RTI episodes, including 42 LRTIs. The cumulative incidence of RTI was 40% at 100 days and 64.8% at 250 days. For LRTIs, incidence was 8.9% at 100 days and 12.2% at 250 days. Among LRTIs, 82.9% were mild, 14.6% moderate, and 2.4% severe. More than half of LRTI episodes required hospitalization, and 14.3% required intensive care. Samples have been collected from 91% of episodes for laboratory analysis.
These findings confirm the feasibility of long-term active surveillance in this cohort and the high frequency of early-life respiratory infections. The continued study will provide critical insights into the incidence, mechanisms, and long-term health consequences of RTIs in Latin American children, supporting the development of new preventive and therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| • Newborns younger than 29 days of life, with or without pre-existing conditions | – | –Infants whose parent(s) or guardian(s) are available for telephone contact for the duration of the study, do not intend to relocate outside of the study area, provide informed consent to participate in the study and are willing to authorize data and specimen collection, storage and analysis. |
Who may qualify
- Ages
- Up to 29 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborns younger than 29 days of life, with or without pre-existing conditions
Key inclusion criteria (4 listed)
- Newborns younger than 29 days of life, with or without pre-existing conditions
- Infants whose parent(s) or guardian(s) are available for telephone contact for the duration of the study, and do not intend to relocate outside of the study area, to ensure adherence to RTI and in-person visits.
- Infants whose parent(s) or guardian(s) provide informed consent to participate in the study.
- Infants whose parent(s) or guardian(s) are willing to authorize data and specimen collection, storage and analysis.
Key exclusion criteria (1 listed)
- Infants born to a pregnant mother under 14 years of age (under Colombian law, pregnancies occurring in individuals younger than 14 years of age are legally presumed to result from sexual abuse).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence rate
Time frame: From enrollment, up to 2 years of age.
The number and etiology of new cases of RTI and LRTI according to cumulative time at risk and month of occurrence, in children aged 0 to 2 years.
3 secondary outcomes
Severity by pathogen
Time frame: From enrollment, up to 2 years of age
Burden in in-patient and outpatient settings
Time frame: From recruitment, up to 2 years of age
Pneumococcal bacterial load and Host immune response
Time frame: From recruitment, up to 2 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- 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.
Eduardo Lopez-Medina, MD, MSc principal investigator
Centro de Estudios en Infectologia Pediatrica, CEIP
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections (RTI) and Lower Respiratory Tract Infection (LRTI), run by Eduardo Lopez -Medina at 2 sites in 2 countries.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia, Panama. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Lopez-Medina, MD, MSc (+57 315 0467762, eduardo.lopez@ceiponline.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate (time frame: From enrollment, up to 2 years of age.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2025.