A randomized double-blinded placebo-controlled crossover trial of nebulized taurolidine in adult cystic fibrosis patients infected with Burkholderia cepacia.
Burkholderia cepacia is an aggressive pathogen that colonizes cystic fibrosis (CF) patients, causing greatly increased morbidity and mortality. It is resistant to most antibiotics, but sensitive in vitro to a novel agent, taurolidine. This has not previously been used against B. cepacia, nor given in nebulized form. We assessed the effect of nebulized taurolidine on United Kingdom epidemic (ET12) B. cepacia infection in 20 adult CF patients attending our regional adult cystic fibrosis outpatient clinic using a prospective, randomized, double-blinded placebo-controlled crossover trial. Nebulized taurolidine (4 mL 2% solution) or saline (4 mL 0.9% solution) was given twice daily. Each arm lasted 4 weeks, with a 2-week intervening washout period. Sputum B. cepacia colony counts (primary outcome measure), spirometry, and symptoms (secondary outcome measures) were assessed. Eighteen patients completed the study. There was no change in B. cepacia colony counts or spirometry, nor symptom scores. We conclude that, although taurolidine is well tolerated in nebulized form, in this study it had no in vivo anti-B. cepacia activity.
Ledson
Martin J
MJ
Regional Adult Cystic Fibrosis Unit, Liverpool University, Liverpool, United Kingdom.
Gallagher
Malcolm J
MJ
Robinson
Maxine
M
Cowperthwaite
Carolyn
C
Williets
Trevor
T
Hart
Charles A
CA
Walshaw
Martin J
MJ
D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019121:Burkholderia Infections / Q000188:drug therapy*; D016956:Burkholderia cepacia / Q000302:isolation & purification; D015169:Colony Count, Microbial; D018592:Cross-Over Studies; D003550:Cystic Fibrosis / Q000382:microbiology*; D004311:Double-Blind Method; D004352:Drug Resistance, Microbial; D005260:Female; D006801:Humans; D008297:Male; D009330:Nebulizers and Vaporizers; D011446:Prospective Studies; D013147:Spirometry; D013183:Sputum / Q000382:microbiology; D013654:Taurine / Q000008:administration & dosage* / Q000031:analogs & derivatives; D013829:Thiadiazines / Q000008:administration & dosage*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D013829:Thiadiazines; D013654:Taurine; C012566:taurolidine