One of the key goals of the Conect4Children consortium (c4c) is the selection and funding of Proof-of-viability (non-commercial and Industry) studies. On April 29, 2019, the selection of the first portfolio of pan-European pediatric academic studies was published:
Sponsor | French National Institute of Health and Medical Research (INSERM) |
Therapeutic Area | Paediatrics, Neonatology |
Study Title | Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen |
Study Acronym | TREOCAPA |
Study Type | Interventional |
CT Phase | Phase II/III |
Nº EudraCT | 2019-004297-26 |
Number of Countries | 17 |
Number of Sites (Portugal) | 3 |
Portuguese sites and PIs | CHULN, EPE – HSM, André Graça, MD, PhD CHUP, EPE -CMIN, Elisa Proença, MD 2CA – Braga, Almerinda Pereira, MD |
Target of Patients (Global) | Phase II: 30 Phase III: 794 |
Target of Patients (Portugal) | Phase III: 27 |
% recruitment achived | Under submission |
National Coordinator | André Graça, MD, PhD |
Status | Authorized by INFARMED (National Competent Authority). Favourable opinion by CEIC (National Ethics Committee for Clinical Research) obtained. |
Sponsor | Ospedale Pediatrico Bambino Gesu (OPBG) |
Therapeutic Area | Paediatrics, Pulmonology |
Study Title | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection |
Study Acronym | cASPerCF |
Study Type | Interventional |
CT Phase | Phase II/III |
Nº EudraCT | 2019-004511-31 |
Number of Countries | 12 |
Number of Sites (Portugal) | 1 |
Portuguese sites and PIs | CHULN, EPE -HSM, Celeste Barreto, MD |
Target of Patients (Global) | Large screening phase: 1500 Intervention phase: 135 |
Target of Patients (Portugal) | Large screening phase: 25 Intervention phase: 4 |
% recruitment achieved (Portugal) | Under submission |
National Coordinator | N/A |
Status | Start-up |