Respiratory tract infection Bacterial infection with Pseudomonas aeruginosa Chronic obstructive pulmonary disease (COPD) Non-cystic fibrosis bronchiectasis Asthma MedDRA version: 20.0 Level: LLT Classification code 10021860 Term: Infection Pseudomonas aeruginosa System Organ Class: 100000004862
Conditions
Interventions
Product Name: Ciprofloxacin
Pharmaceutical Form: Tablet
INN or Proposed INN: ciprofloxacin hydrochloride
CAS Number: 86393-32-0
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Concent
Sponsors
COP:TRIN Region Hovedstaden (Gentofte hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Lower respiratory sample with Pseudomonas aeruginosa - COPD, non-CF bronchiectasis or asthma - History of minimum 2 exacerbations or 1 hospital/emergency department-requiring exacerbation with administration of systemic prednisolone and/or antibiotic treatment within the last 12 months Are the trial subjects under 18? no 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Immune modulating therapy - Male 55 years - Expected lifetime < 90 days - Severe psychiatric disease - Severe language problems - Known allergy against fluorquinolon and both penicillin/piperacillin, cefalosporin and carbapenem - Received eradication therapy against PA twice within the last 12 months or full completion of eradication therapy against PA within the last 14 days - Investigator thinks that trial participant should receive antibiotics for PA under all circumstances. This exclusion criterion must be discussed with the coordinating investigator before the final decision is taken
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of the trial is to investigate if targetted antibiotics against respiratory tract infection with Pseudomonas aeruginosa can improve the prognosis in patients with COPD, non-CF bronchiectasis and asthma. Patients will be allocated to the following 2 study arms: 1) no antibiotic treatment 2) intravenous tazocin 4/0.5 g four times daily + tablet ciprofloxacin 500 mg twice daily for 14 days ;Secondary Objective: A) To investigate if infection with Pseudomonas aeruginosa is an independent predictor for exacerbation and mortality i patients with COPD (nationwide database study). B) To investigate if Pseudomonas aeruginosa causes chronic colonisation or rather episodic infections in the respiratory tract in patients with COPD (genetic study: prospective pilot study of the randomized study).;Primary end point(s): - Time to prednisolone and/or antibiotic requiring exacerbation or death, in primary or secondary health care sector from day 20 to day 365 from randomization. - Days alive and without exacerbation from day 20 to day 365 from randomization. ;Timepoint(s) of evaluation of this end point: Evaluated when 2/3 (67%) of the patients in the mono therapy group have had an exacerbation, expected within 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Evaluated when 2/3 (67%) of the patients in the mono therapy group have had an exacerbation, expected within 12 months.;Secondary end point(s): - Death within 12 months - Number of COPD exacerbations within 12 months - Number of days with non-invasiv-ventilation (NIV) or intubation within 90 days from inclusion - Change in FEV1 from baseline to 3 months - Fall in FEV1 from baseline = 200 ml at day 365 - Change in COPD Assessment Test (CAT) from baseline to 3 months - Change in body mass index (BMI) from baseline to 3 months - Microbiological cure - Clinical cure - For patients with COPD: days alive and out of hospital within day 20-365 from randomization | — |
Countries
Denmark
Contacts
Public ContactGentofte Hosptial
COP:TRIN Region Hovedstaden
Outcome results
None listed