FindTrial
Sign In

Evaluation of the efficacy of antibiotic treatments associated with the Nebcine® as intravenous injection only and / or monitoring of aerosols of Tobi® in order to optimize the therapeutic management of exacerbations in patients with cystic fibrosis .

Evaluation of the effectiveness of a treatment involving one (or several ) antibiotic (s) with 14-day tobramycin ( Nebcine® ) by intravenous injection versus the same antibiotic treatment (s ) associated with only 5 days of tobramycin ( Nebcine® ) by intravenous injection followed tobramycin aerosol ( Tobi® ) for 9 days in the context of cystic fibrosis

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-003882-10-FR
Enrollment
Unknown
Registered
2015-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-02

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

Conditions

mucoviscidosis or cystic fibrosis MedDRA version: 18.0 Level: LLT Classification code 10068288 Term: Cystic fibrosis pulmonary exacerbation System Organ Class: 100000004862

Interventions

Trade Name: NEBCINE Product Name: NEBCINE Pharmaceutical Form: Solution for injection CAS Number: 32986-56-4 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type:

Sponsors

CHRU de Lille
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s): ;Timepoint(s) of evaluation of this end point: J0 and J16—

Countries

France

Contacts

Public ContactFédération de Recherche Clinique

CHRU de Lille

drc@chru-lille.fr0033320444145

Outcome results

None listed

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