Dettagli per singolo studio

DEC-NET Serial number IT197

Published online
Last updated	04/05/2006 16.15.03

Other protocol ID number
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
Major Disease (ICD9 class)	CYSTIC FIBROSIS W ILEUS
Experimental drug
TOBRAMYCIN Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	From 0 days to 18 years
Eligibility criteria
Inclusion criteria
All patients with Cystic Fibrosis that began TOBI before 30th June 2003. Patients that between 30th June 2003 - 30th June 2004 o previously, began and later stopped the drug for several reasons (side effects, inefficacy, etc.) without completing the follow-up at 6 months or 1 year. All patients that took and/or continue to take TOBI, including patients in whom the drug was stopped due to side effects at first dose. Patients in whom the drug was used with the aim to eradicate pseudomonas aeruginosa at its first or new isolation, even in patients less than 6 years. Patients to whom TOBI was given in addition to other drugs or antibiotics by aerosol.


Trial design/methodology
Phase	4
Kind of study	Efficacy Safety
Design	retrospettivo
Purpose of study
Primary objectives: Established in a realistic non controlled clinical context the impact of TOBI on clinical care wellbeing indicators and especially: a. Reduction of number of days of hospital stay and of antibiotic therapies for respiratory exacerbations b. Respiratory function (spyrometry) c. Treatment side effects d. "True" compliance Secondary objectives: Description and judgement on: a. Epidemiology of other treatments (if any modified by TOBI) b. Health care practises (internal audit) c. Treatment benefit/cost




Summary of study design, objectives, and ongoing research findings
The study is a retrospective, post-marketing surveillance study to evaluate the impact of TOBI (tobramycin) in patients with cystic fibrosis in a realistic, non-controlled clinical context by measuring clinical, well-being indicators (reduction in days of hospital stay, in antibiotic therapies, in missed school or work days, respiratory function, treatment side effects, true compliance). The secondary objectives are to describe and evaluate the epidemiology of other treatments (if any modified by TOBI), of health care practices, and of treatment benefit/risk. The first results show that, in general, 68% of the patients eradicated pseudomonas aeruginosa (PA) at the end of the 12 month follow-up period. A more aggressive therapy at the start of the TOBI study, with the use of TOBI in association with another antibiotic seems to be associated with a greater probability of eradication (66% vs 91%), and this result (91%) is in line with the results of 3 other surveillance studies with follow-ups of at least one year. In patients with more severe clinical conditions (identified especially by their use of intravenous antibiotics for exacerbation), a lower percentage of success is expected. Overall, 12% of therapy suspensions were due to side effects (at different times, but especially in the first 6 months, 9%), 10% to PA eradication, 5% to scarce efficacy or symptom worsening, and 2% for other causes. The results of this study tend to suggest that the association between aerosol (use of TOBI) and oral (ciprofloxacin) antibiotics is more effective in eradicating PA than TOBI alone. The results show that, for patients with chronic PA colonization, the use of TOBI does not seem to have reduced the number of days in hospital significantly, the number of iv antibiotic, not those oral antibiotics scheduled. However, there is a reduction in number of days of oral antibiotic therapy per exacerbation.