Community-acquired PneumoniaIMPACTNCT05114902
PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study
An observational study of Community-acquired Pneumonia, run by Asian Foundation for Tropical Medicine Inc. at 1 site in Philippines.
Trial summary
Prospective, observational, hospital based, nasopharyngeal carriage (NPC), vaccine effectiveness study Comparisons will be made in Filipino children, aged 8 weeks to ≤60 months of age at enrollment, who have been hospitalized with a radiologically-confirmed, community-acquired pneumonia (CAP). Read more about this study
- Who is it for?
- Ages 8 weeks to 60 months
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Nasopharyngeal swab
- Type of treatment
- Vaccines
- How many people
- 451 participants
- Where
- 1 sitePhilippines
- Study dates
- 24 Nov 2021to Nov 2024
- Phase
- Observational
- 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 8 weeks to 60 months
- All sexes
- No healthy volunteers
- Child
Study population: Children 8 weeks to ≤60 months of age from the National Capital Region (NCR) or Region X-XIII admitted with a medical diagnosis of clinical community-acquired pneumonia (CAP), confirmed by an abnormal chest x-ray. In Region X-XIII, the child must have received at least 1 dose of PCV13 given at <12 months.
Who may be able to join
- Child 8 weeks to ≤60 months of age
- Resident of the National Capital Region (NCR) or Region X-XIII
- Child admitted with a medical diagnosis of clinical CAP based on history and physical exam
- Written informed consent obtained from a parent or legal guardian
- At SPMC site, child must have received at least 1 dose of PCV13 given at <12 months based on history-taking
- For Phase B at PCMC site, child must have received at least 1 dose of PCV13 given at <12 months based on history-taking
Who cannot join
- Children with a known primary or secondary immunodeficiency
- Child with a contraindication to doing a nasopharyngeal swab which may include, but is not limited to: dyscrasias, coagulation disorders, or other diseases (e.g., hemophilia, purpura), presence of craniofacial abnormalities32
- For Phase A at PCMC site, child with any PCV in the past based on history-taking
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Philippine Children's Medical Center
Quezon City, National Capital Region
About this study
Official title: Assessing the Impact of PCV13 on Pneumococcal Nasopharyngeal Colonization in Children 8 Weeks to ≤60 Months of Age Hospitalized for Pneumonia in the Philippines
Prospective, observational, hospital based, nasopharyngeal carriage (NPC), vaccine effectiveness study Comparisons will be made in Filipino children, aged 8 weeks to ≤60 months of age at enrollment, who have been hospitalized with a radiologically-confirmed, community-acquired pneumonia (CAP).
Read the detailed description
This study will be the first of two phases (A and B). Phase A will compare a PCV13-vaccinated setting (SPMC) with an unvaccinated setting (PCMC)
- Conditions
- Community-acquired Pneumonia
- Being tested
- Nasopharyngeal swab
- Keywords
- Clinical CAP
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swabDiagnostic test
A sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage
| Study group | Role | What they receive |
|---|---|---|
| PCV13 Non-vaccinated Settting | Pneumococcal vaccine-naïve children at the PCMC Receives: Diagnostic Test: Nasopharyngeal swab | |
| PCV13 Vaccinated Setting | Pneumococcal vaccine-exposed children at the SPMC Receives: Diagnostic Test: Nasopharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
S. pneumoniae serotypes
- pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (PCMC)
Measured: Upon Admission
S. pneumoniae serotypes Upon Admission
- pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (SPMC)
Measured: Upon Admission
Antimicrobial resistance rate of S. pneumoniae
Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13- unvaccinated site (PCMC)
Measured: Upon Admission
Antimicrobial resistance rate of S. pneumoniae
Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13-vaccinated site (SPMC)
Measured: Upon Admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start24 Nov 2021
- Primary completion31 Jul 2023
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Foundation for Tropical Medicine Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Philippine Children's Medical Center, Southern Philippines Medical Center
- Responsible party
- Principal investigator, Marilla Lucero, Asian Foundation for Tropical Medicine Inc.
- Investigators
- Marilla G Lucero, MD, Principal investigator, Asian Foundation for Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114902
- Sponsor's protocol ID
- CT-44 Study Protocol AFTM-01
- Acronym
- IMPACT
- Status last verified
- Sep 2023
- First submitted
- 29 Oct 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of PCV13 on Pneumococcal Nasopharyngeal Colonization in Children 8 Weeks to ≤60 Months of Age Hospitalized for Pneumonia in the Philippines
- ClinicalTrials.gov ID
- NCT05114902
- Acronym / sponsor ID
- IMPACT / CT-44 Study Protocol AFTM-01
- Conditions
- Community-acquired Pneumonia
- Keywords
- Clinical CAP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Asian Foundation for Tropical Medicine Inc.University, hospital or other
- Collaborators
- Pfizer, Philippine Children's Medical Center, Southern Philippines Medical Center
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- Nov 2024 (estimated)
- First posted
- 10 Nov 2021 (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.
Prospective, observational, hospital based, nasopharyngeal carriage (NPC), vaccine effectiveness study Comparisons will be made in Filipino children, aged 8 weeks to ≤60 months of age at enrollment, who have been hospitalized with a radiologically-confirmed, community-acquired pneumonia (CAP).
Detailed description
This study will be the first of two phases (A and B). Phase A will compare a PCV13-vaccinated setting (SPMC) with an unvaccinated setting (PCMC)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCV13 Non-vaccinated Settting | – | Diagnostic Test: Nasopharyngeal swabPneumococcal vaccine-naïve children at the PCMC |
| PCV13 Vaccinated Setting | – | Diagnostic Test: Nasopharyngeal swabPneumococcal vaccine-exposed children at the SPMC |
Who may qualify
- Ages
- 8 weeks to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 8 weeks to ≤60 months of age from the National Capital Region (NCR) or Region X-XIII admitted with a medical diagnosis of clinical community-acquired pneumonia (CAP), confirmed by an abnormal chest x-ray. In Region X-XIII, the child must have received at least 1 dose of PCV13 given at <12 months.
Key inclusion criteria (6 listed)
- Child 8 weeks to ≤60 months of age
- Resident of the National Capital Region (NCR) or Region X-XIII
- Child admitted with a medical diagnosis of clinical CAP based on history and physical exam
- Written informed consent obtained from a parent or legal guardian
- At SPMC site, child must have received at least 1 dose of PCV13 given at <12 months based on history-taking
Key exclusion criteria (3 listed)
- Children with a known primary or secondary immunodeficiency
- Child with a contraindication to doing a nasopharyngeal swab which may include, but is not limited to: dyscrasias, coagulation disorders, or other diseases (e.g., hemophilia, purpura), presence of craniofacial abnormalities32
- For Phase A at PCMC site, child with any PCV in the past based on history-taking
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 |
|---|---|---|
| Nasopharyngeal swabA sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage | Diagnostic test | PCV13 Non-vaccinated Settting, PCV13 Vaccinated Setting |
Primary outcome
S. pneumoniae serotypes
Time frame: Upon Admission
S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (PCMC)
S. pneumoniae serotypes Upon Admission
Time frame: Upon Admission
S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (SPMC)
Antimicrobial resistance rate of S. pneumoniae
Time frame: Upon Admission
Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13- unvaccinated site (PCMC)
Antimicrobial resistance rate of S. pneumoniae
Time frame: Upon Admission
Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13-vaccinated site (SPMC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
Related trials for Community-acquired Pneumonia
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingPhase 3
CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL
Sepsis
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
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.
Marilla G Lucero, MD principal investigator
Asian Foundation for Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia, run by Asian Foundation for Tropical Medicine Inc. at 1 site in Philippines.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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 Philippines. 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?
Results are not available in the source record.
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?
S. pneumoniae serotypes (time frame: Upon Admission). The study lists 4 primary outcomes in all. 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 13 Sep 2023.