Pharmacokinetics of nasally administered tobramycin and colistin in Cystic Fibrosis

Pharmacokinetics of nasally administered tobramycin and colistin in Cystic Fibrosis - SPOEL study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38737

Enrollment

Registered

2013-02-13

Start date

2013-06-20

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Cystic Fibrosis mucoviscidosis

Interventions

Each patient irrigates the nose with tobramycin mixed with isotonic saline once, colistin dissolved in isotonic saline once and tobramycin and colistin together dissolved in isotonic saline once. In

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnose of Cystic Fibrosis based on genotyping or a positive sweat test 2. Age >= 18 years 3. Intravenous course of tobramycin in the past, but within the age of >= 18 years, with a creatinine value measured during that same intravenous course of tobramycin

Exclusion criteria

Exclusion criteria: 1. Kidney dysfunction (defined as estimated Glomerular Filtration Rate of = 3 times the normal value) 3. Intravenous treatment with aminoglycosides or polymyxins

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters, including AUC (area under the curve), tmax (time to maximum concentration), Cmax (maximum plasma concentration), t1/2,el (terminal half-life) and F (bioavailability).	—

Secondary

Measure	Time frame
• CL (total body clearance) • safety of the nasal irrigations with tobramycin, colistin and a combination of tobramycin and colistin, determined by systemic absorption (bioavailability) • adverse reactions • Visual Analogue Scale (VAS) score for (in)convenience of the nasal irrigations	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)