Tobramycin Once-daily Prescribing In Cystic Fibrosis
| DEC-NET Serial number GB294 | |
| Published online | 21/07/2004 10.59.00 |
| Last updated | 21/07/2004 12.29.27 |
| Other protocol ID number | Lancet Protocol reference 99PRT/22 |
| This trial has been approved by an ethics committee | |
| Current trial status | Complete(closed to recruitment of participants: follow-up complete) |
| Major Disease (ICD9 class) | Cystic fibrosis |
| Experimental drug | |
| TOBRAMYCIN | |
| Gender | Both |
| Age (range) | 5 years and above |
Eligibility criteria | |
| Inclusion criteria | |
| 1. Cystic Fibrosis 2. Can do lung function test 3. At least one isolate of P. aeruginosa 4. Last isolate sensitive to ceftazidime or tobramycin. | |
| Exclusion criteria | |
| 1. Burkholderia cepacia 2. Intolerance of study drugs 3. Severe hearing or renal impairment. | |
Trial design/methodology | |
| Phase | 4 |
| Kind of study | Efficacy Safety |
| Design | Controlled Randomised Blinded Double blind |
| Purpose of study | |
| To evaluate the efficacy and safety of once vs. three times daily tobramycin (combined with a standard regimen of ceftazidime) for pulmonary exacerbations of cystic fibrosis. | |
| Primary outcomes | |
| Change in FEV1, expressed as % predicted, over 14 days | |
| Secondary outcomes | |
| 1. Nephrotoxicity (change in creatinine & NAG) 2. Ototoxicity (audiogram) 3. Clinical score 4. Time to next intravenous treatment. | |
| Summary of study design, objectives, and ongoing research findings | |
| A randomised controlled trial of once vs three times daily tobramycin for pulmonary exacerbations of cystic fibrosis. | |
| Principal investigator | |
| Name | Alan Smyth |
| Institution | Nottingham City Hospital |
| Postal address | Hucknall Road, NG5 1PB |
| City | Nottingham, NG5 1PB |
| Country | UNITED KINGDOM |
| Phone | 0115 969 1169 ext 46475 |
| Fax | 0115 962 0564 |
| alan.smyth@nottingham.ac.uk | |
| Sponsor name |
| UK Cystic Fibrosis Trust (Scientific organisation) |
| I-Flow Corporation (Industry) |
| Chiron Corporation (Industry) |
| Fresenius (Industry) |
| Participating centres |
| Nottingham City Hospital (Nottingham ) |
| Birmingham Heartlands Hospital (Birmingham ) |
| Birmingham Children.s Hospital (Birmingham ) |
| Birmingham City Hospital (Birmingham ) |
| Royal Liverpool Children.s Hospital (Liverpool ) |
| St James Hospital (Leeds) |
| Southampton Hospital (Southampton ) |
| Walsgrave Hospital (Coventry) |
| Royal Belfast Hospital for Sick Children (Belfast ) |
| Belfast City Hospital (Belfast ) |
| Royal Alexandra Hospital for Children (Brighton) |
| Royal Victoria Infirmary (Newcastle) |
| Bradbury CF Unit, Wythenshaw Hospital (Manchester) |
| Royal Gwent Hospital (Newport) |
| Royal Northern Hospital (Sheffield) |
| Arrowe Park Hospital (Merseyside) |
| Great Ormond Street Hospital (London) |
| Lewisham Hospital (Lewisham ) |
| ISRCTN | EudraCT |
