PROJECTS REVOLUTION SLIDER TEMPLATE HOOK ME UP

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 pan-European pediatric academic studies was published:

  • TREOCAPA – Paracetamol in Premature Babies: Will assess the effectiveness of paracetamol in premature babies with a patent ductus arteriosus, and aims to recruit around 600 babies as part of the study (Lead: Prof. Jean-Christophe Roze of INSERM, a public research organization in Paris, France entirely dedicated to human health).
     
  • KD-CAAP – Steroids to Treat Kawasaki Disease: Will assess the effectiveness of adding steroids to standard treatment in children with Kawasaki Disease, and aims to recruit 262 children as part of the study (Leads: Dr. Despina Eleftheriou and Prof Paul Brogan of the University College of London (UCL), an academic research institution in the UK).

 

  • cASPerCFPosaconazole in Children with Cystic Fibrosis: Will assess the dose of posaconazole in children and young people with Cystic Fibrosis and infection with Aspergillus and aims to recruit 130 children as part of the study (Lead: Prof. Adilia Warris of the MRC Centre for Medical Mycology, University of Aberdeen and Ospedale Pediatrico Bambino Gesù (OPBG), a children’s hospital in Rome, Italy).
     

 

In the tables below you can find detailed information on the TREOCAPA and cASPerCF Proof-of-viability (non-commercial and Industry) studies with participating Portuguese sites.

 

 

TREOCAPA

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
EU Clinical Trials Register LINK
ClinicalTrials.org LINK
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
National Coordinator André Graça, MD, PhD
Status Recruitment

 

 

 

cASPerCF

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
EU Clinical Trials Register LINK
ClinicalTrials.org LINK
Portugal Clinical Trials LINK
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
National
Coordinator
N/A
Status Suspended in 2022

 

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777389. The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA