Randomized, double-blind, parallel-group clinical trial, compared with placebo to evaluate the efficacy and safety of three antibiotic treatment regimens for the eradication of primary P. aeruginosa infection in patients with bronchiectasis

Status

Not yet recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524454-34-00

Enrollment

160

Registered

2026-06-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-09

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

Conditions

Bronchiectasis

Brief summary

Microbiological eradication of PA, measured by negative cultures from sputum or bronchoscopic sample (only if clinically performed as part of usual care) at 3 months after treatment initiation.

Detailed description

Early microbiological eradication at 1 and 2 months, Sustained eradication at 6 and 12 months., Exacerbation frequency, Safety, Quality of life, Serum biomarkers levels, Costs

Interventions

DRUG0.9% Sodium Chloride Intravenous Infusion Solution

DRUGColfinair 2 millones de UI polvo para solución para inhalación por nebulizador

DRUGCiprofloxacino Normon 250 mg comprimidos recubiertos con película EFG

DRUGCiprofloxacino Normon 500 mg comprimidos recubiertos con película EFG

DRUGCelulosa Microcristalina: 98

DRUG05 g+ Sílice Coloidal: 1

DRUG95 g

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Microbiological eradication of PA, measured by negative cultures from sputum or bronchoscopic sample (only if clinically performed as part of usual care) at 3 months after treatment initiation.	—

Secondary

Measure	Time frame
Early microbiological eradication at 1 and 2 months, Sustained eradication at 6 and 12 months., Exacerbation frequency, Safety, Quality of life, Serum biomarkers levels, Costs	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 11, 2026