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Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old.

randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-006171-19-IT
Enrollment
Unknown
Registered
2012-01-13
Start date
2011-10-27
Completion date
Unknown
Last updated
2012-07-03

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

Conditions

Cystic fibrosis patients with early P.aeruginosa infection. MedDRA version: 14.1 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: CIPROXIN*6CPR RIV 500MG Pharmaceutical Form: Tablet INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500

Sponsors

AZIENDA OSPEDALIERA MEYER
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patients with cystic fibrosis disease -regular frequency in the CF centers -sensibility of P. aeruginosa to the sperimental therapy -patients over 5 years -patients with early infection from P. aeruginosa without clinical signs of respiratory exacerbation Are the trial subjects under 18? yes Number of subjects for this age range: 65 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -intermittent or chronic infection from P. aeruginosa -history of adverse events to the RCT treatment -earing failure, liver and renal disfunctions -macrolid used in the 3 months before the RCT

Design outcomes

Primary

MeasureTime frame
Main Objective: Compare between 2 different antibiotics protocols (oral cyprofloxacin and inhaled promixin vs oral cyprofloxacin and inhaled tobramycin) for the eradication of early P. aeruginosa infection in patients with cystic fibrosis disease.;Secondary Objective: -evaluation of the hematic antibody answer - evaluation of the respiratory functionality tests (FEV1) -evaluation of the growth BMI, of the of relapses number, and of the antibiotic's use.;Primary end point(s): Eradication of early infection;Timepoint(s) of evaluation of this end point: 6 months—

Secondary

MeasureTime frame
Secondary end point(s): -evaluation of the hematic antibody answer - evaluation of the respiratory functionality tests (FEV1) -evaluation of the growth BMI, of the of relapses number, and of the antibiotic's use.;Timepoint(s) of evaluation of this end point: 2 years—

Countries

Italy

Contacts

Public ContactAMBULATORIO FIBROSI CISTICA

AOU MEYER

g.taccetti@meyer.it0555662474

Outcome results

None listed

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