Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT06909903
Brief Summary:
Cystic fibrosis requires regular monitoring of bacterial colonization of sputum. The collection is done during scheduled consultations or urgently during exacerbations during the respiratory physiotherapy session, which is increasingly often associated with nebulization of Hypertonic Salt Serum (SSH). This allows, compared to simple expectoration, to obtain a greater density and diversity of germs. However, no study has focused on researching the precise place of origin of the collected secretions. Our aim is therefore to compare, in this pilot study in 20 adolescents suffering from cystic fibrosis and regularly followed at the pediatric CRCM, the ratio between squamous cells (CM, ENT origin) and broncho-alveolar cells in sputum obtained spontaneously and induced with of the SSH (collaboration with Professor Roll). The secondary criteria are the CM/bronchial cell ratio, the CM/alveolar macrophage ratio, cell viability and microbiological diversity. The hypothesis of this research is as follows: the nebulization of SSH before expectoration makes it possible to obtain a greater quantity of secretions from the broncho-alveolar sphere than during simple expectoration. In the cohort of 165 patients followed at the pediatric CRCM of Marseille, only 25 patients correspond to the inclusion criteria: they are between 12 and 17 years old, master autogenous drainage as well as spontaneous expectoration in sufficient quantity to carry out the research. They must also have been in stable clinical condition for at least one month. Taking into account the non-inclusion criteria (refusal to participate, systemic antibiotic therapy, respiratory decompensation or upper airway infection, SpO2 less than 92% before nebulization, appearance of hemoptysis in the last three months), the number of subjects is fixed. To 20. Each patient participates in a single day of hospitalization scheduled at the pediatric CRCM: at 9 a.m. simple expectoration and at 1 p.m., expectoration caused by SSH. The subject is therefore his own witness. The study inclusion period is one year.
Study:
NCT06909903
Study Brief:
Protocol Section:
NCT06909903