Observation of the treatment of cystic fibrosis patients with Pseudomonas aeruginosa lung infection with ColiFin 1Mio I.E. or ColiFin 2Mio I.E.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00009540

Enrollment

100

Registered

2016-01-19

Start date

2016-03-21

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic infection with Pseudomonas aeruginosa Cystic fibrosis E84 B96.5

Interventions

Group 1: Observation of ColiFin 1Mio. I.E. and ColiFin 2Mio. I.E. treatment within the authorised indication over a period of 6 months.

Eligibility

Sex/Gender

All

Age

2 Years to No maximum

Inclusion criteria

Inclusion criteria: Chronic pulmonary infections due to Pseudomonas aeruginosa in adult and paediatric patients with cystic fibrosis

Exclusion criteria

Exclusion criteria: No chronic pulmonary infections due to Pseudomonas aeruginosa in adult and paediatric patients with or without cystic fibrosis

Design outcomes

Primary

Measure	Time frame
Goal of this non-interventional study is to gain data on the prescription behaviour for ColiFin.	—

Secondary

Measure	Time frame
Further more detailed perception of the therapy with ColiFin 1Mio./2Mio. I.E. within the authorised indication in the routine practise is expected.	—

Countries

Germany

Contacts

Public ContactRainald Fischer

Lungenheilkunde München-Pasing

rainald.fischer@lmu.de089-880347

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026