Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa. MedDRA version: 18.1 Level: LLT Classification code 10051190 Term: Pneumonia Pseudomonas aeruginosa System Organ Class: 100000004862 MedDRA version: 18.1 Level: LLT Classification code 10050700 Term: Chronic respiratory disease NOS System Organ Class: 100000004855
Conditions
Interventions
Trade Name: colistimethate sodium (promixin)
Pharmaceutical Form: Inhalation vapour, powder
INN or Proposed INN: COLISTIMETHATE SODIUM
CAS Number: 8068-28-8
Concentration unit: IU international unit(s
Sponsors
Aarhus University Hospital, Department of Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, the patient must meet all of the following criteria: · Signed informed consent to participate in the study in accordance with local regulations · Diagnosed with a chronic pulmonary disease by lung functions test or CT · Diagnosed with one positive sputum sample with PA during the last year · Age 18 - 85 years inclusive · Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: · Prophylactic treatment with any other antibiotic · Allergy to tazocin, ciprofloxacin or colistimethate-sodium · Patients who are pregnant or planning a pregnancy · Patients with any solid organ transplant · Patients with cystic fibrosis · Patients on assisted ventilation · Bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion or otherwise curable causes (e.g. foreign body aspiration) · Be considered "terminally ill" or listed for transplantation · Actively treated Mycobacterium tuberculosis or other mycobacteria · Patients in a condition or in a situation, which in the investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Chronic pulmonary disease patients often gets bacterial pneumonia with the bacteria Pseudomonas Aeruginosa, often with severe morbidity and mortality as a result. It is well examined for patients with cystic fibrosis, but for non-cystic fibrosis chronic pulmonary disease patients our knowledge is sparse. The standard treatment at the moment is 14 days of a combination of intravenously and oral antibiotic. We will examine whether we can more effectively clear the infection with inhaled colistimethate and oral ciprofloxacin. Furthermore we will follow the patient with pulmonary function tests, sputum samples for relapse infections and clinical assessments.;Secondary Objective: Secondary end points is to examine the current and future immune status of the infected patient and to examine their experience of “quality of life” between the control and intervention group during 1 year of follow up. Further more we will examine whether we can make an assessment of the risk for the patient when they debut with their infection by means of biomarkers.;Primary end point(s): 1: Number of positive Pseudomonas (PA) sputum cultures after treatment and 12, 26 and 52 weeks after end of treatment. If possible PCR for PA oprf gene. 2: Number of specific immune deficiencies and their relation to baseline clinical status and clinical outcome. 3: Number of precipitating antibodies during intervention and follow-up, measured 26 and 52 weeks after treatment.;Timepoint(s) of evaluation of this end point: Each patient will be followed for a year. The trial will run for 2-3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Relative change from baseline of FVC (% predicted), FEV1 (% predicted), DLCO and 6minuttes walking test (6MWT) at follow-up. 2: Subjective change in dyspnea, cough and quality of life after treatment and at follow-up. 3: Numbers of exacerbations and hospital admissions after treatment 4: Assess whether immune deficiencies can be used as a prognostic factor 5: Changes in immunoglobulins, interferon gamma and lymphocytes during follow-up 6: Number of pre-treatment precipitating antibodies and their relation to the number of cleared PA infections, change in lung function and dyspnea score at 12, 26 and 52 weeks after treatment. 7: Correlation between detected exotoxins, exoenzymes and TNFR75 on clinical outcome determined by the numbers of exacerbations, number of sputum eradications of PA, time to sputum eradication of PA, time to stabilization of pulmonary function, 6MWT and survival. 8: Correlation between detected plasma elastase and alkaline protease on clinical outcome determined by the numbers of exacerbations, number of sputum eradications of PA, time to sputum eradication of PA, time to stabilization of pulmonary function, 6MWT and survival.;Timepoint(s) of evaluation of this end point: Each patient will be followed for a year. The trial will run for 2-3 years. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Respiratory Medicine
Aarhus University Hospital
Outcome results
None listed