PediatricsPresapNCT07350291
Evaluation of the Diagnostic Capabilities of Saliva Samples From Pediatric Patients, Promoting Active Involvement of the Individuals Concerned and Their Families.
A study testing The aim is to compare the effectiveness of virological and bacterial detection between two sampling methods in people with Pediatrics and Virus Diseases in Children, run by Poitiers University Hospital.
Trial summary
The management of respiratory infections accounts for a large proportion of winter activity in paediatric wards. The main pathologies are bronchiolitis, affecting infants under the age of 2. Read more about this study
- Who is it for?
- Ages 28 days to 23 months
- Conditions the study is for
- Pediatrics, Virus Diseases in Children
- What is being tested?
- The aim is to compare the effectiveness of virological and bacterial detection between two sampling methods
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jul 2030
- Phase
- Interventional
- 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 28 days to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged between 28 days and under 24 months.
- Admission to paediatric A\&E or general paediatrics.
- Respiratory conditions requiring treatment for microbiological diagnosis by upper airway sampling.
- Collection of consent signed by legal representatives or guardians with parental authority. Except in cases where there is a single parent with parental authority.
- Persons affiliated with or beneficiaries of a social security scheme.
- Exclusion Criteria:• Refusal to participate by one of the legal representatives or the patient.
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- Patients with a contraindication to ASNA (those with haemophilia, on anticoagulants or with thrombocytopenia).
- Patients with a known increased risk of epistaxis (nosebleeds), hypertrophic rhinitis or other conditions causing excessive mucosal fragility.
- Participation in another study that would impact the primary objective of this research.
- Patients who may be allergic to the material used in the sponge pacifier.
- Patients in a life-threatening emergency situation.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Diagnostic Capabilities of Saliva Samples From Pediatric Patients, Promoting Active Involvement of the Individuals Concerned and Their Families: Protocol for a Randomized Intra-individual Study.
The management of respiratory infections accounts for a large proportion of winter activity in paediatric wards. The main pathologies are bronchiolitis, affecting infants under the age of 2. Today, the reference method for diagnosing respiratory pathogen infections is nasopharyngeal aspirate (NPA), performed by paramedical staff. However, this technique is invasive and traumatic for paediatric patients. During the SARS-CoV-2 pandemic, salivary sampling was used on a large scale in the paediatric population, and showed good concordance with reference samples, as well as better tolerance/acceptability. The aim of the PreSaP (Paediatric Saliva Sampling) study is to assess the diagnostic capabilities of saliva samples¹ . This will be a monocentric, intra-individual, randomised study involving 502 children using the results of nasopharyngeal aspirates as the gold standard. We will also evaluate the time required to take nasopharyngeal aspirates and saliva samples in order to examine any difficulties associated with the two sampling methods. Although the results of our study report few diagnostic errors, they would justify the use of saliva sampling in routine care to reduce stressful and painful factors, and thus contribute to the well-being of infants and children. Saliva sampling could improve acceptance by the child and those around him, avoiding a less negative experience while guaranteeing a reliable diagnosis of respiratory pathogens. This new technique should also encourage the active involvement of all those involved in care.
- Conditions
- Pediatrics, Virus Diseases in Children
- Being tested
- The aim is to compare the effectiveness of virological and bacterial detection between two sampling methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The aim is to compare the effectiveness of virological and bacterial detection between two sampling methodsDiagnostic test
Also called standard, experimental
The nasopharyngeal swab and the buccal swab will be taken separately as a cross over with randomisation carried out to allow a different order for each patient. The collection time, the quantity of virus, the quality of the sample and the human intervention will be quantified.The pain and comfort of both carers and children will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Standard arm with nasopharyngeal suction | Active comparator | This stand sample is the current gold standard for collecting winter virii in paediatrics. It consists of aspirating serosities via a nasopharyngeal device. Receives: Diagnostic Test: The aim is to compare the effectiveness of virological and bacterial detection between two sampling methods |
| Experimental arm with nasopharyngeal swab | Experimental | This experimental sample will consist of inserting a weighted dummy into the oral cavity, in order to obtain a sample of the child's saliva and compare it with the standard sample. Receives: Diagnostic Test: The aim is to compare the effectiveness of virological and bacterial detection between two sampling methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with a detection of respiratory pathogens
This intra-individual trial (cross-over trial where two samples are taken from each child) aims to assess the ability of a test to detect respiratory pathogens from a saliva sample, using nasopharyngeal aspiration (NPA) as the gold standard.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PediatricsStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 502 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350291
- Sponsor's protocol ID
- Presap
- Other IDs
- PHRIP
- Acronym
- Presap
- Status last verified
- Nov 2025
- First submitted
- 31 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Devienne L, Goram L, Morton-Fauche C, Foucher Y, Pelras A, Leveque N, Binet A, Bouchet C, Pitard C, Beaumatin G, Deroche L. Evaluation of the diagnostic capacities of saliva sampling from pediatric patients: Protocol for a randomized intra-individual study. MethodsX. 2026 Jul 8;17:104038. doi: 10.1016/j.mex.2026.104038. eCollection 2026 Dec.
PubMed 42502776
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Capabilities of Saliva Samples From Pediatric Patients, Promoting Active Involvement of the Individuals Concerned and Their Families: Protocol for a Randomized Intra-individual Study.
- ClinicalTrials.gov ID
- NCT07350291
- Acronym / sponsor ID
- Presap / Presap
- Conditions
- Pediatrics, Virus Diseases in Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 502 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 20 Jan 2026 (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 management of respiratory infections accounts for a large proportion of winter activity in paediatric wards. The main pathologies are bronchiolitis, affecting infants under the age of 2. Today, the reference method for diagnosing respiratory pathogen infections is nasopharyngeal aspirate (NPA), performed by paramedical staff. However, this technique is invasive and traumatic for paediatric patients. During the SARS-CoV-2 pandemic, salivary sampling was used on a large scale in the paediatric population, and showed good concordance with reference samples, as well as better tolerance/acceptability. The aim of the PreSaP (Paediatric Saliva Sampling) study is to assess the diagnostic capabilities of saliva samples¹ . This will be a monocentric, intra-individual, randomised study involving 502 children using the results of nasopharyngeal aspirates as the gold standard. We will also evaluate the time required to take nasopharyngeal aspirates and saliva samples in order to examine any difficulties associated with the two sampling methods. Although the results of our study report few diagnostic errors, they would justify the use of saliva sampling in routine care to reduce stressful and painful factors, and thus contribute to the well-being of infants and children. Saliva sampling could improve acceptance by the child and those around him, avoiding a less negative experience while guaranteeing a reliable diagnosis of respiratory pathogens. This new technique should also encourage the active involvement of all those involved in care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm with nasopharyngeal suction | Active comparator | Diagnostic Test: The aim is to compare the effectiveness of virological and bacterial detection between two sampling methodsThis stand sample is the current gold standard for collecting winter virii in paediatrics. It consists of aspirating serosities via a nasopharyngeal device. |
| Experimental arm with nasopharyngeal swab | Experimental | Diagnostic Test: The aim is to compare the effectiveness of virological and bacterial detection between two sampling methodsThis experimental sample will consist of inserting a weighted dummy into the oral cavity, in order to obtain a sample of the child's saliva and compare it with the standard sample. |
Who may qualify
- Ages
- 28 days to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Infants aged between 28 days and under 24 months.
- Exclusion Criteria:• Refusal to participate by one of the legal representatives or the patient.
- Patients with a contraindication to ASNA (those with haemophilia, on anticoagulants or with thrombocytopenia).
- Patients with a known increased risk of epistaxis (nosebleeds), hypertrophic rhinitis or other conditions causing excessive mucosal fragility.
- Participation in another study that would impact the primary objective of this research.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| The aim is to compare the effectiveness of virological and bacterial detection between two sampling methodsAlso: standard, experimentalThe nasopharyngeal swab and the buccal swab will be taken separately as a cross over with randomisation carried out to allow a different order for each patient. The collection time, the quantity of virus, the quality of the sample and the human intervention will be quantified.The pain and comfort of both carers and children will be assessed. | Diagnostic test | Experimental arm with nasopharyngeal swab, Standard arm with nasopharyngeal suction |
Primary outcome
Number of patient with a detection of respiratory pathogens
Time frame: Day 1
This intra-individual trial (cross-over trial where two samples are taken from each child) aims to assess the ability of a test to detect respiratory pathogens from a saliva sample, using nasopharyngeal aspiration (NPA) as the gold standard.
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 20 Jan 2026.
- Derived from this study: PubMed 42502776Devienne L, Goram L, Morton-Fauche C, Foucher Y, Pelras A, Leveque N, Binet A, Bouchet C, Pitard C, Beaumatin G, Deroche L. Evaluation of the diagnostic capacities of saliva sampling from pediatric patients: Protocol for a randomized intra-individual study. MethodsX. 2026 Jul 8;17:104038. doi: 10.1016/j.mex.2026.104038. eCollection 2026 Dec.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing The aim is to compare the effectiveness of virological and bacterial detection between two sampling methods in people with Pediatrics and Virus Diseases in Children, run by Poitiers University Hospital.
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 11 inclusion and 0 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Guillaume BEAUMATIN (+33 549443652, guillaume.beaumatin@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient with a detection of respiratory pathogens (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07350291, which also lists 1 linked publication.
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 20 Jan 2026.