Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0

• Conditions: Cystic Fibrosis

• Registration Number: EUCTR2010-023529-39-GB
• Lead Sponsor: Southampton University Hopsitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-31
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adolescents and young adults with cystic fibrosis aged 12 or above
• Colonised with Pseudomonas aeruginosa (50% or more of all cultures in the last 12 months positive for Pseudomonas aeruginosa)

Criteria for randomisation:
• Requiring antibiotic therapy for a pulmonary exacerbation:

A pulmonary exacerbation will be defined according to the criteria published by the 1994 cystic fibrosis foundation microbiology and infectious disease consensus and used in recent large clinical trials.

The presence of 3 of the following 11 criteria:
? Increased cough
? Increased sputum production, change in appearance of expectorated sputum production, or both
? Fever (greater than or equal to 38°C for at least 4 hrs in a 24 hrs period) on more than one occasion in the previous week
? Weight loss greater than or equal to 1kg or 5% of bodyweight associated with anorexia and decreased dietary intake
? School or work absenteeism (due to illness) in the previous week
? Increased respiratory rate, increased work of breathing, or both
? New findings on chest examination (e.g. rales, wheezing, crackles)
? Decreased exercise tolerance
? Decrease in FEV1 of greater than or equal to 10% from previous baseline study within the past 3 months
? Decrease in haemoglobin saturation (as measured by oximetry) from baseline value within past 3 months of greater than or equal to 10%
? New finding on chest radiograph

Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• 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 canula 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified