Cystic fibrosis Nutritional, Metabolic, Endocrine Cystic fibrosis (CF)
Conditions
Interventions
Current interventions as of 14/04/2011:
Arm A: 14 days Intravenous (iv) Ceftazidime 50 miligram (mg)/kilogram (kg)/dose, to a maximum of 3 grams (g) three times daily (tds) and IV tobr
Sponsors
University Hospitals Bristol (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/04/2011: 1. Diagnosis of CF 2. Children over the age of 28 days, older children and adult CF participants are all eligible with no upper age limitation 3. Competent adults should provide fully informed written consent to particpiate in the trial 4. Minors should have proxy consent by the parent or legal guardian and should provide assent where applicable to participate in the trial 5. The patient should have isolated P.aeruginosa and should be either: 5.1. P. aeruginosa-naïve (i.e., has never previously isolated P. aeruginosa) or 5.2. P. aeruginosa-free (i.e., a minimum number of four consecutive cough or sputum samples should be P. aeruginosa free within a 12 month period to satisfy eligibility) 6. The particpiant should be able to commence treatment no later than 21 days from the date of a P. aeruginosa positive microbiology report Previous inclusion criteria: 1. Diagnosis of CF 2. The patient should have given full written consent, or assent where applicable, to participate in the trial 3. The participant should be able to commence treatment no later than three weeks after the clinical team has been informed that P.aeruginosa has been isolated 4. The patient should have isolated P.aeruginosa and should be either: 4.1. Pseudomonas-naïve (i.e. has never previously isolated P. aeruginosa) or 4.2. Pseudomonas-free i.e. has not isolated P. aeruginosa from cough swab, sputum or bronchoalveolar lavage samples within the previous 12 months
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 14/04/2011: 1. Antibiotic resistance of the current P.aeruginosa sample to any of: ciprofloxacin, ceftazidime, tobramycin or colistin reported by local microbiology laboratory 2. Known patient hypersensitivity to either ciprofloxacin, ceftazidime, tobramycin or colistin 3. Other known contraindications to any of ciprofloxacin, ceftazidime, tobramycin or colistin including previous aminoglycoside hearing or renal damage 4. Participant receiving P. aeruginosa suppresing treatment, in particular nebulised colistin or tobramycin, or oral ciproflxacin for the previous 9 months. Please note, short courses of oral ciprofloxacin or intravenous antibiotics (with an anti-pseudomonal spectrum of action) are not an exclusion unless they are given to treat proven infections with P. aeruginosa 5. Treatment with other anti-pseudomonal nebuliser 6. Pregnant and nursing mothers (women of child bearing age will be counselled on the risks of becoming pregnant during the trial and will be offered a preganancy test) 7. Previous randomisation in TORPEDO-CF study 8. Previous participation in another intervention trial within four weeks of taking part in TORPEDO-CF Previous exclusion criteria: 1. Antibiotic resistance of the current P.aeruginosa sample to any of: ciprofloxacin, ceftazidime, or tobramycin reported by local microbiology lab 2. Known patient hypersensitivity to either ciprofloxacin, ceftazidime or tobramycin 3. Other known contraindications to any of ciprofloxacin, ceftazidime or tobramycin, including previous aminoglycoside hearing or renal damage 4. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful eradication of P.aeruginosa infection three months after allocated treatment has started, remaining infection free through to 15 months after the start of allocated treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 14/04/2011: 1. Time to reoccurrence of original P.aeruginosa infection 2. Re-infection with a different genotype of P.aeruginosa 3. Lung function - FEV1 , FVC, FEF25-75 4. O2 saturation 5. Growth and nutritional status - height, weight and body mass index 6. Number of pulmonary exacerbations 7. Admission to hospital 8. Number of days spent as inpatient in hospital over the three month period after allocated treatment has finished, and between three months and 15 months after eradication treatment has finished (other than 14 days spent on initial IV treatment) 9. Quality of life (CFQ) 10. Utility (EQ-5D) 11. Adverse events 12. Other sputum/cough Microbiology (Methicillin resistant Staphylococcus aureus (MRSA), Burkholderia cepacia complex, Aspergillus, Candida Infection) 13. Cost per patient (from NHS perspective) 14. Incremental cost effectiveness ratio (cost per successfully treated patient, cost per QALY) 15. Carer burden (absenteeism from school or work) 16. Participant burden (absenteeism from education or work) Previous secondary outcome measure: 1. Time to reoccurrence of P.aeruginosa infection 2. Time to new P.aeruginosa infection 3. Lung function - FEV1 , FVC, FEF25-75 4. Growth and nutritional status - height, weight and body mass index 5. Number of pulmonary exacerbations 6. Admission to hospital 7. Number of days spent as inpatient in hospital at three months and between three months and 15 months (other than 14 days spent on initial IV treatment) 8. Quality of life (CFQ) 9. Utility (EQ-5D) | — |
Countries
England, United Kingdom
Outcome results
None listed