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NCT Number: NCT07350291

Evaluation of the Diagnostic Capabilities of Saliva Samples From Pediatric Patients, Promoting Active Involvement of the Individuals Concerned and Their Families.

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.

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Key information

Age range

28 day–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

  • 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.

Treatment and study plan

The aim is to compare the effectiveness of virological and bacterial detection between two sampling methods

Diagnostic Test

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.

Other names: standard, experimental

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume BEAUMATIN

CONTACT

[email protected]

+33 549443652

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study 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.

Acronym: Presap

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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