Comparison of a β-lactam alone versus β-lactam and an aminoglycoside for pulmonary exacerbation in cystic fibrosis

We determined whether a β-lactam and an aminoglycoside have efficacy greater than a β-lactam alone in the management of a pulmonary exacerbation in patients with cystic fibrosis. Study design: Azlocillin and placebo or azlocillin and tobramycin were administered to 76 patients with a pulmonary exace...

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Published in:	The Journal of pediatrics Vol. 134; no. 4; pp. 413 - 421
Main Authors:	Smith, Arnold L., Doershuk, Carl, Goldmann, Donald, Gore, Edward, Hilman, Bettina, Marks, Melvin, Moss, Richard, Ramsey, Bonnie, Redding, Gregory, Rubio, Thomas, Williams-Warren, Judy, Wilmott, Robert, Wilson, H.David, Yogev, Ram
Format:	Journal Article
Language:	English
Published:	New York, NY Mosby, Inc 01-04-1999 Elsevier Mosby-Year Book, Inc
Subjects:	Adolescent Analysis of Variance Anti-Bacterial Agents - adverse effects Anti-Bacterial Agents - therapeutic use Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Azlocillin - adverse effects Azlocillin - therapeutic use Biological and medical sciences Child Cystic Fibrosis - drug therapy DNA, Bacterial - drug effects DNA, Bacterial - isolation & purification Double-Blind Method Drug Therapy, Combination - therapeutic use Female Humans Injections, Intravenous Male Medical sciences Penicillins - adverse effects Penicillins - therapeutic use Pharmacology. Drug treatments Pseudomonas aeruginosa - drug effects Pseudomonas aeruginosa - isolation & purification Respiratory Function Tests Sputum - drug effects Sputum - microbiology Tobramycin - adverse effects Tobramycin - therapeutic use Vital Capacity - drug effects FVC FEV 1 PEFR ANOVA FRC Human Drug combination Respiratory disease β-Lactams Metabolic diseases Cystic fibrosis Genetic disease Infection Antibiotic Aminoglycoside Digestive diseases Complication Antiinfectious Child Comparative study Pancreatic disease
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Summary:	We determined whether a β-lactam and an aminoglycoside have efficacy greater than a β-lactam alone in the management of a pulmonary exacerbation in patients with cystic fibrosis. Study design: Azlocillin and placebo or azlocillin and tobramycin were administered to 76 patients with a pulmonary exacerbation caused by Pseudomonas aeruginosa in a randomized double-blind, third-party monitored protocol. Improvement was assessed by standardized clinical evaluation, pulmonary function testing, sputum bacterial density, sputum DNA content, and time to the next pulmonary exacerbation requiring hospitalization. Results: No significant difference was seen between the 2 treatment groups in clinical evaluation, sputum DNA concentration, forced vital capacity, forced expiratory volume in second 1, or peak expiratory flow rate at the end of treatment (33 receiving azlocillin alone and 43 both antibiotics); adverse reactions were equivalent in each group. Sputum P. aeruginosa density decreased more with combination therapy ( P = .034). On follow-up evaluation, an average of 26 days after the end of treatment, all outcome indicators had worsened in both groups. Time to readmission for a new pulmonary exacerbation was significantly longer in the group receiving azlocillin plus tobramycin ( P < .001). Treatment-emergent tobramycin resistance occurred in both groups and was more frequent with combination therapy. Conclusion: We conclude that the combination of a β-lactam and an aminoglycoside produces a longer clinical remission than a β-lactam alone and slightly better initial improvement. (J Pediatr 1999;134:413-21)
ISSN:	0022-3476 1097-6833
DOI:	10.1016/S0022-3476(99)70197-6