Status:
COMPLETED
RATNO, Reducing Antibiotic Tolerance Using Nitric Oxide in CF - a Phase 2 Pilot Study
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
University of Southampton
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
The lungs of most patients with cystic fibrosis (CF) become chronically infected with bacteria called Pseudomonas aeruginosa during childhood. This infection is now known to consist of free-living bac...
Detailed Description
Not required
Eligibility Criteria
Inclusion
- Adolescents and young adults with cystic fibrosis aged 12 or above
- Colonised with Pseudomonas aeruginosa (confirmed on sputum sample)
Exclusion
- Colonisation with Burkholderia cepacia
- Known hypersensitivity to the antibiotics used in the study
- Other known contraindications to the antibiotics to be used in the study including known aminoglycoside related hearing/renal damage
- Patients requiring non-invasive ventilation (NIV)
- Patients who have a pneumothorax
- Patients who are admitted for specific treatment of nontuberculous mycobacteria (NTM)
- Patients who cannot tolerate nasal cannula e.g. those who cannot breathe through their nose
- Patients who have nasal polyposis that is causing significant blockage of the nasal passages
- Adolescents who are not Gillick competent (and therefore not able to give their own assent in addition to parental consent)
- Patients not likely to survive the time period of the study washout period (4 months from enrolment)
- Treatment with an investigational drug or device within the last 3 months prior to enrolment
- Patients who are pregnant (a pregnancy test will be carried out for females of 11 years and above as is standard practice for clinical trials)
- Immediate families of investigators or site personnel directly affiliated with the study. Immediate family is defined as child or sibling, whether biological or legally adopted.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02295566
Start Date
May 1 2011
End Date
July 1 2013
Last Update
May 30 2024
Active Locations (1)
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1
University Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD