EUCTR2015-003662-87-DK
Active, not recruiting
Phase 1
Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life - Pseudomonas, Tazocin or Colistin
Aarhus University Hospital, Department of Respiratory Medicine0 sitesSeptember 22, 2015
ConditionsChronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa.MedDRA version: 18.1Level: LLTClassification code 10051190Term: Pneumonia Pseudomonas aeruginosaSystem Organ Class: 100000004862MedDRA version: 18.1Level: LLTClassification code 10050700Term: Chronic respiratory disease NOSSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa.
- Sponsor
- Aarhus University Hospital, Department of Respiratory Medicine
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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:
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
Outcomes
Primary Outcomes
Not specified
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