Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EcN · 1 trial · 1 indication
The total number of infections observed for each participant during its individual study participation standardised per month during the first 24 months of life. An infection is an episode of illness caused by: * Acute upper respiratory tract infections * Acute lower respiratory tract infections * Otitis media * Gastroenteritis * Urinary tract infections The duration of an episode of illness is defined as the time from the appearance of the first symptom of a study relevant infection to the disappearance of the last symptom. Infections that occur concurrently or one after another within a period of 7 days are only counted separately, if they belong to different groups of illness. All rhinitides that occur in the first year of a child's life are considered for the count of the primary efficacy variable. Rhinitides that occur in the second year will only be included if they were accompanied by fever (body temperature higher than 38.4°C during at least one measure).
| Arm | Type | Description |
|---|---|---|
| EcN-Suspension | EXPERIMENTAL | 279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with EcN-Suspension |
| Placebo | PLACEBO_COMPARATOR | 279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with Placebo |
| Name | Type | Description |
|---|---|---|
| EcN-Suspension | DRUG | Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks). Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day). |
| Placebo | DRUG | Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks). Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day). |
Inclusion Criteria: * Signed informed consent form by the parents * Age at inclusion: max. 120 hours after birth * Functionally mature infant * Gestational age more than 35th week of development * Mother's intention to breastfeed the participant * Readiness of the mother to administer no probiotics...
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EcN is an investigational small molecule being developed for the prevention of infections. It is currently in Phase 3 clinical development. EcN is being studied as a suspension for infection prophylaxis, with a completed Phase 3 trial evaluating its use in this setting.
EcN is being developed by Icon Plc, a company traded on the stock exchange under the ticker ICLR. Icon Plc is conducting clinical trials to evaluate the safety and efficacy of EcN for infection prophylaxis.
EcN is in Phase 3 clinical development. A Phase 3 trial has been completed, which enrolled 567 participants. The trial was randomized, double-blind, and placebo-controlled, and it evaluated EcN as a suspension for infection prophylaxis.
EcN has one completed Phase 3 clinical trial registered under NCT02802059, titled 'E. Coli Nissle 1917 - Suspension for Infection Prophylaxis.' This trial enrolled 567 participants and was conducted in Germany and Poland. The trial was randomized, double-blind, and placebo-controlled.
EcN is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. A Phase 3 trial has been completed, but the drug has not yet received regulatory approval for use in treating or preventing infections.