| Autor: |
Soledad Munoz-Ramirez, Begoña Escribano-López, Vallivana Rodrigo-Casares, Carlos Vergara-Hernández, Desamparados Gil-Mary, Ignacio Sorribes-Monrabal, María Garcés-Sánchez, María-Jesús Muñoz-Del-Barrio, Ana-María Albors-Fernández, María-Isabel Úbeda-Sansano, María-Victoria Planelles-Cantarino, Ester-María Largo-Blanco, Eva Suárez-Vicent, Javier García-Rubio, Patricia Bruijning-Verhagen, Alejandro Orrico-Sánchez, Javier Díez-Domingo |
| Rok vydání: |
2021 |
| Popis: |
BACKGROUND Hybrid clinical trials can be an alternative to traditional clinical trials with vaccines. A hybrid clinical trial may be assisted by parental recording of symptoms using electronic log diaries in combination with home collected nasal swabs. OBJECTIVE Our primary aim was to assess the feasibility of these procedures in the context of a clinical trial with the influenza vaccine in toddlers. METHODS Children aged 12 to 35 months with a history of recurrent acute respiratory infections were recruited in 7 primary health centers of the Valencia Region in Spain. Parents completed a symptom diary through an ad hoc mobile app that subsequently assessed whether it was an acute respiratory infection and requested collection of a nasal swab. Feasibility was measured using the percentage of returned electronic diaries and the validity of nasal swabs collected during an influenza season. Respiratory viruses were detected by real-time PCR. RESULTS 52 toddlers were enrolled. Parents completed 5,652 electronic diaries out of the 5915 requested (95.5%). The mobile app requested collection of 119 swabs, of which 88.2% were collected. Of swabs available, 101 (96.2%) were collected at home and 88 (87.1%) were adequate for testing. Overall, 92 (76.5%) of the possible acute respiratory infections declared in the app had a valid sample. CONCLUSIONS Hybrid procedures can be regarded as feasible during a clinical trial with the influenza vaccine in toddlers. Hybrid clinical trials improve participant adherence to the study procedures and could improve recruitment and quality of life of the participants and the research team by decreasing the number of visits to the investigator site. CLINICALTRIAL 2019-001186-33 (EudraCT) |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
