A randomised cross over pilot study of inhaled tobramycin as a treatment option for hospitalised patients with cystic fibrosis versus standard treatment of intravenous tobramycin

Is inhaled tobramycin as effective as intravenous tobramycin and potentially less toxic for treating acute exacerbations of lung infection in those patients with cystic fibrosis (CF) who are chronically colonised with Pseudomonas aeruginosa?

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000016235

Enrollment

Registered

2009-01-08

Start date

2008-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study hopes to show that when tobramycin is given via inhalation in those patients with cystic fibrosis who are sick enough to need intravenous (into a vein) antibiotics, the levels in the lung are adequate for effective bacteria killing and that they recover from the acute infection. The study will be undertaken in all eligible patients who are admitted to the hospital for treatment of an exacerbation of their lung infection.

Interventions

Each participant will receive either IV tobramycin at the dose they received on their last admisson (usually 7-10mg/kg) once daily for 14 days or they will receive inhaled tobramycin at a dose of 300mg twice a day for 14 days. Once thier treatment has been completed they will cease these medications and will receive the other arm of the study on their next admission. Their admissions must be a minimum of 6 weeks apart.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

6 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of cystic fibrosis, chronically colonised with Pseudomonas aeruginosa, Forced Expiratory Volume in 1 second (FEV1) > 25%, having an exacerbation of their lung infection

Exclusion criteria

Patients who are pyrexial with a temperature of >38.0C , allergic to aminoglycosides, patients with calculated creatinine clearance <50mL/min/1.73m2

Outcome results