CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Efficacy of inhaled tobramycin in the treatment of pulmonary exacerbations in children with cystic fibrosis.

Study design (if review, criteria of inclusion for studies)

RCT

Participants

16 CF patients in the intravenous plus inhaled tobramycin group were similar to the 12 control patients in age, sex, Schwachman seores, pulmonary function and pretreatment colony counts of Pseudomonas aeruginosa in sputum.

Interventions

intravenous ticarcillin (300 mg drug per kg per day) and tobramycin (10 mg drug per kg per day) versus the same intravenous antibiotic therapy plus inhaled tobramycin (80 mg three times per day).

Outcome measures

clinical status and pulmonary function without, eradication of P. aeruginosa, renal toxicity, elevations of serum tobramycin

Main results

Treatment resulted in significant improvement in clinical status and pulmonary function without any apparent differences in the two groups. However, in travenous plus inhaled tobramycin resulted in temporary eradication of P. aeruginosa in 63% of the patients compared to 25% in the intravenous only group (P = 0.03). Suppression of P.aeruginosa in sputum cultures did not correlate with clinical response to treatment. No renal toxicity or elevations of serum tobramycin were observed in the intravenous plus inhaled tobramycin group.

Keywords: Adolescent; Adult; Anti-Bacterial Agents; Child; Inhalation OR nebulised; pharmacological_intervention; Tobramycin; Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Infection; Exacerbation; Pseudomonas aeruginosa; Pseudomonas; Intravenous; Ticarcillin; Penicillins; Aminoglycosides;