Detail of the clinical trial
| Title of the trial | A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection |
|---|---|
| EudraCT number | 2017-002156-84 |
| Protocol number | 63623872FLZ3001 |
| Sponsor | Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium |
| Indications | Infection (including sepsis, antibiotics) |
| Diagnosis | Influenza A Infection |
| Population in clinical trial |
Adolescents (12-17 years) Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2018 |
| Date of approval by Institute (SÚKL) | 16.7.2018 |
| Date of approval by EC | 4.4.2018 |
| Date of initiation CT in ČR | 19.12.2019 |
| Date of ending CT in ČR | 11.9.2020 |
| Notice | |
| Sites |
Nemocnice Na Bulovce,Klinika infekčních, parazitárních a tropických nemocí,Budínova 67/2,Praha 8,180 81 Fakultní nemocnice Brno,Klinika infekčních chorob,Jihlavská 20 ,Brno ,625 00 Nemocnice Kyjov,Infekční oddělení,Strážovská 1247/22,Kyjov ,697 01 Fakultní nemocnice Ostrava,Klinika infekčního lékařství FNO a LF OU,17. listopadu 1790/5,Ostrava - Poruba ,708 52 |
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