Early antibiotic treatment forPseudomonas aeruginosaeradication in patients with cystic fibrosis: a randomised multicentre study comparing two different protocols

Abstract

Background Pseudomonas aeruginosa chronic pulmonary infection is an unfavourable event in cystic fibrosis. Bacterial clearance is possible with an early antibiotic treatment upon pathogen isolation. Currently, no best practice exists for early treatment. The efficacy of two different regimens against initial P aeruginosa infection was assessed. Methods In a randomised, open-label, parallel-group study involving 13 centres, the superiority of inhaled tobramycin/oral ciprofloxacin compared with inhaled colistin/oral ciprofloxacin (reference treatment) over 28 days was evaluated. Patients were eligible if they were older than 1 year with first or new P aeruginosa isolation. Treatments were assigned equally by centralised balanced randomisation, stratified by age and forced expiratory volume in 1 s values. The participants and those giving the intervention were not masked to arm assignments. The primary endpoint was P aeruginosa eradication, defined as three successive negative cultures in 6 months. Analysis was by intention to treat. This trial was registered with EudraCT, number 2008-006502-42. Results 105 patients were assigned to inhaled colistin/ oral ciprofloxacin (arm A) and 118 to inhaled tobramycin/ oral ciprofloxacin (arm B). All patients were analysed. P aeruginosa was eradicated in 66 (62.8%) patients in arm A and in 77 (65.2%) in arm B (OR 0.90, 95% CI 0.52 to 1.55, p¼0.81). Following treatment, an increase in Stenotrophomonas maltophilia was noted (OR 3.97, 95% CI 2.27 to 6.94, p¼0.001) with no differences between the two arms (OR 0.89, 95% CI 0.44 to 1.78, p¼0.88). Conclusions No superiority of treatment under study was demonstrated in comparison to the reference treatment. Early eradication treatment was associated with an increase in S maltophilia.

Antibiotic and Anti-Inflammatory Therapies for Cystic Fibrosis

“…Subsequent studies, such as the ELITE and EPIC studies, have shown that inhaled tobramycin for 4 wk is also an effective antibiotic eradication therapy (Ratjen et al 2010;Treggiari et al 2011). In two small studies, no difference was identified between these two regimes with a comparable eradication rate (Taccetti et al 2012;Proesmans 2013).…”

Novosti v Obravnavi Pljučne Bolezni Pri Otrocih in Mladostnikih S Cistično Fibrozo

“…Odločno zdravljenje prve okužbe s PA je premaknilo začetek kronične okužbe s to bakterijo za 3,5 let pri skoraj 80 % otrok. 15,16 PregledNi člaNek/reView Osebe, ki pa že imajo kronično okužbo s PA, je potrebno doživljenjsko zdraviti z inhalacijskimi antibiotiki npr. tobramicinom.…”

Solution of the Problem of Pseudomonas Infection in Children with Cystic Fibrosis

“…Эрадикация в конце курса лечения была схожей: 90% в группе ципрофлоксацин + колистин и 79% -в группе тобрамицина. Исследование показало, что 3 мес лечения ингаляционным колистином вместе с пероральной формой ципрофлоксацина и 28-дневный курс монотерапии тобрамицином имеют высокую и схожую эффективность с 80-90% эрадикацией P. aeruginosa по окончании курса лечения Раствор тобрамицина для ингаляций совместно с пероральной формой ципрофлоксацина против раствора колистина для ингаляций и пероральной формой ципрофлоксацина для терапии ранней инфекции P. aeruginosa [29] Исследование …”