Pulmonary DiseasesCAPRI-PCNCT03740646
Pneumocystis Primary Infection in Non-immunosuppressed Infants
An observational study of Pulmonary Diseases and Fever, run by University Hospital, Brest at 1 site in France.
Trial summary
To determine the prevalence of P. jirovecii in nasopharyngeal aspirations of neonates and infants hospitalized for symptomatic respiratory infection. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Pulmonary Diseases, Fever
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2019to 31 May 2021
- 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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: symptomatic newborns and infants who underwent NPAs for microbiological diagnoses
Who may be able to join
- symptomatic newborns and infants who underwent NPAs for microbiological diagnoses
Who cannot join
- asymptomatic newborns and infants, newborns and infants who did not undergo NPAs, infants > 12 months or children > 2 years; newborns and infants whose parents did not accept to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary-Pneumocystis Infection: Pneumocystis Jirovecii Detection in Nasopharyngeal Aspirates From Symptomatic Infants
To determine the prevalence of P. jirovecii in nasopharyngeal aspirations of neonates and infants hospitalized for symptomatic respiratory infection.
Read the detailed description
It is recognized that primary infection with Pneumocystis, an opportunistic and transmissible fungus, occurs early in childhood. Early investigations of primary infection considering the detection of P. jirovecii in respiratory specimens suggests that primary infection in infants without immunodeficiency could be either asymptomatic or symptomatic. The infection may be identified as an apparently benign respiratory infection evolving on its own, but may also be contemporaneous with another viral or bacterial respiratory infection. In addition, there are little data available on the genotypic characteristics of P. jirovecii in infants developing primary infection.
In this context, the project will focus on the detection of P. jirovecii in hospitalized infants, presented with symptoms, and without overt immunodeficiency. The prospective collection of biological, clinical and epidemiological data in these infants will make it possible to identify risk factors for the acquisition of the fungus and to address its role in symptoms and clinical presentation. A second focus will be on the identification and comparison of genotypes in infants developing primary infection and in immunocompromised adults developing PPC or colonized by the fungus. These two approaches are the necessary steps to address the putative role of these patient populations (infants and adults) in the human reservoir of the fungus. A third focus will be the detection and genotypic identification of P. jirovecii in infants and the exhaled air of infants in their environment. The potential role of infants as potential infectious sources may be determined.
- Conditions
- Pulmonary Diseases, Fever
- Keywords
- Bronchiolitis, Nasopharyngeal aspirates
- Medical subject headings
- Lung Diseases, Fever, Bronchiolitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumocystis presence or not in nasopharyngeal specimens from newborns and infants
The main biological parameter which will be measured will be the positive or negative result of P. jirovecii detection in nasopharyngeal apsirate specimens from non-immunosuppressed newborns and infants. The prevalence of P. jirovecii comtemporary with first contacts with the fungus will be assessed.
Measured: At patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start21 Jan 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NEVEZ Gilles, MD PhD, Principal investigator, Brest University Hospital, Brest, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740646
- Sponsor's protocol ID
- CAPRI-PC( 29BRC18.0052)
- Acronym
- CAPRI-PC
- Status last verified
- Sep 2021
- First submitted
- 8 Nov 2018
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary-Pneumocystis Infection: Pneumocystis Jirovecii Detection in Nasopharyngeal Aspirates From Symptomatic Infants
- ClinicalTrials.gov ID
- NCT03740646
- Acronym / sponsor ID
- CAPRI-PC / CAPRI-PC( 29BRC18.0052)
- Conditions
- Pulmonary Diseases, Fever
- Keywords
- Bronchiolitis, Nasopharyngeal aspirates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 14 Nov 2018 (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.
To determine the prevalence of P. jirovecii in nasopharyngeal aspirations of neonates and infants hospitalized for symptomatic respiratory infection.
Detailed description
It is recognized that primary infection with Pneumocystis, an opportunistic and transmissible fungus, occurs early in childhood. Early investigations of primary infection considering the detection of P. jirovecii in respiratory specimens suggests that primary infection in infants without immunodeficiency could be either asymptomatic or symptomatic. The infection may be identified as an apparently benign respiratory infection evolving on its own, but may also be contemporaneous with another viral or bacterial respiratory infection. In addition, there are little data available on the genotypic characteristics of P. jirovecii in infants developing primary infection.
In this context, the project will focus on the detection of P. jirovecii in hospitalized infants, presented with symptoms, and without overt immunodeficiency. The prospective collection of biological, clinical and epidemiological data in these infants will make it possible to identify risk factors for the acquisition of the fungus and to address its role in symptoms and clinical presentation. A second focus will be on the identification and comparison of genotypes in infants developing primary infection and in immunocompromised adults developing PPC or colonized by the fungus. These two approaches are the necessary steps to address the putative role of these patient populations (infants and adults) in the human reservoir of the fungus. A third focus will be the detection and genotypic identification of P. jirovecii in infants and the exhaled air of infants in their environment. The potential role of infants as potential infectious sources may be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- symptomatic newborns and infants who underwent NPAs for microbiological diagnoses
Key inclusion criteria (1 listed)
- symptomatic newborns and infants who underwent NPAs for microbiological diagnoses
Key exclusion criteria (1 listed)
- asymptomatic newborns and infants, newborns and infants who did not undergo NPAs, infants > 12 months or children > 2 years; newborns and infants whose parents did not accept to participate
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
Pneumocystis presence or not in nasopharyngeal specimens from newborns and infants
Time frame: At patient inclusion
The main biological parameter which will be measured will be the positive or negative result of P. jirovecii detection in nasopharyngeal apsirate specimens from non-immunosuppressed newborns and infants. The prevalence of P. jirovecii comtemporary with first contacts with the fungus will be assessed.
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 8 Sep 2021.
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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.
NEVEZ Gilles, MD PhD principal investigator
Brest University Hospital, Brest, France
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 Pulmonary Diseases and Fever, run by University Hospital, Brest at 1 site in France.
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 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: finished, as of the sponsor's last update on 8 Sep 2021. 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 France. 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?
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?
Pneumocystis presence or not in nasopharyngeal specimens from newborns and infants (time frame: At patient inclusion). 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 8 Sep 2021.