Nebulised Colomycin for Early Pseudomonas Colonisation in Cystic Fibrosis

Littlewood, J M; Miller, M; Ghoneim, A T; Ramsden, C. H.

doi:10.1016/s0140-6736(85)92222-6

Cited by 192 publications

(105 citation statements)

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“…Besides aminoglycosides (gentamicin [144], tobramycin [33, 44, 45, 47, 51] and b-lactam antibiotics (ceftazidime [50] carbenicillin [143]), combinations of both classes have been used [50,60]. Colistin has also been used [43,145,146]. The penicillins have been mostly avoided because of concerns regarding development of hypersensitivity, odour, effect on teeth and greater difficulty in nebulization.…”

Section: Nebulized Antipseudomonal Antibiotic Therapy In Cystic Fibrosismentioning

confidence: 99%

“…Despite these methodological difficulties, most of the studies showed improved lung function [33,45,47,50,143,144] or slowing of the deterioration of lung function [33,44,51] in the active treatment group compared to placebo. Additionally, most studies report a reduction in the number of hospital admissions [50,51,143,144] and some report on a reduction of P. aeruginosa numbers [47,145]. Only one study demonstrated a decrease in inflammation by treatment with aerosolized antibiotics [51].…”

Section: Nebulized Antipseudomonal Antibiotic Therapy In Cystic Fibrosismentioning

confidence: 99%

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Antibiotic therapy against Pseudomonas aeruginosa in cystic fibrosis: a European consensus

Döring¹,

Conway²,

Heijerman³

et al. 2000

Eur Respir J

558

478

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Cystic fibrosis (CF) is the most common lethal hereditary disorder with autosomal recessive heredity in caucasians. The majority of CF patients suffer from chronic respiratory infection with the opportunistic bacterial pathogen Pseudomonas aeruginosa. No consensus among clinicians has been reached so far concerning antibiotic treatment against P. aeruginosa in CF patients.Consensus answers to 24 important questions in this context, based on current evidence, are presented, given by a panel of 34 European experts. Questions addressed and answered are: The diagnosis of P. aeruginosa lung colonization in CF; The impact of P. aeruginosa on the clinical state of CF patients; The assessment of P. aeruginosa susceptibility against antibiotics and the importance of these results for the clinician; The use of monotherapy versus combination therapy; The development of microbial resistance; The achievement of optimal airway concentrations; The effects of subinhibitory concentrations of antibiotics on P. aeruginosa; Statements on the pharmacokinetics of antibiotics in CF patients; Recommendations for doses and dosing intervals and length of treatment regimens; and Toxic side effects due to repeated antibiotic therapy was addressed.The expert panel answered further questions on the use of fluoroquinolones in children with CF, on the administration of nebulized antibiotics and whether prevention of P. aeruginosa lung colonization is possible in CF using antibiotic therapy.Problems of antibiotic therapy at home and in the hospital were addressed, a consensus statement on regular maintenance treatment, or treatment on demand, was given and different routes of administration of antibiotics were recommended for different clinical situations.Finally, the factors which determine the choice of the antibiotic, the dosage, and the duration of the treatment in cystic fibrosis patients were addressed and the design of future antibiotic studies in the context of Pseudomonas aeruginosa lung infection in cystic fibrosis patients were recommended. Eur Respir J 2000; 16: 749±767.

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Section: Nebulized Antipseudomonal Antibiotic Therapy In Cystic Fibrosismentioning

confidence: 99%

Section: Nebulized Antipseudomonal Antibiotic Therapy In Cystic Fibrosismentioning

confidence: 99%

Antibiotic therapy against Pseudomonas aeruginosa in cystic fibrosis: a European consensus

Döring¹,

Conway²,

Heijerman³

et al. 2000

Eur Respir J

558

478

View full text Add to dashboard Cite

show abstract

“…[3][4][5][6][7][8][9][10][11][12][13][14][15][16][17] However, none of these agents have been approved for inhalation and studies evaluating their efficacy have substantial problems in study design, including: small sample size, inadequate blinding of participants, lack of appropriate controls, and failure to consider potential carryover effects in crossover designs. Other aminoglycosides, 18 -20 vancomycin, 21,22 and polymyxin 23 also have been administered by inhalation in different circumstances to patients without CF.…”

Section: Approved Indication For Tobramycin Solution For Inhalation (mentioning

confidence: 99%

Technical Report: Precautions Regarding the Use of Aerosolized Antibiotics

Prober¹,

Walson²,

Jones³

2000

Pediatrics

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ABSTRACT. In 1998, the Food and Drug Administration (FDA) approved the licensure of tobramycin solution for inhalation (TOBI). Although a number of additional antibiotics, including other aminoglycosides, ␤-lactams, antibiotics in the polymyxin class, and vancomycin, have been administered as aerosols for many years, none are approved by the FDA for administration by inhalation.TOBI was approved by the FDA for the maintenance therapy of patients 6 years or older with cystic fibrosis (CF) who have between 25% and 75% of predicted forced expiratory volume in 1 second (FEV 1 ), are colonized with Pseudomonas aeruginosa, and are able to comply with the prescribed medical regimen. TOBI was not approved for the therapy of acute pulmonary exacerbations in patients with CF nor was it approved for use in patients without CF. Currently, no other antibiotics are approved for administration by inhalation to patients with or without CF.The purpose of this statement is to briefly summarize the data that supported approval for licensure of TOBI and to provide recommendations for its safe use. The pharmacokinetics of inhaled aminoglycosides and problems associated with aerosolized antibiotic treatment, including environmental contamination, selection of resistant microbes, and airway exposure to excipients in intravenous formulations, will be discussed. Pediatrics 2000;106(6). URL: http://www.pediatrics.org/cgi/content/ full/106/6/e89; aerosolized antibiotics, tobramycin solution for inhalation; cystic fibrosis; Pseudomonas aeruginosa.ABBREVIATIONS. TOBI, tobramycin solution for inhalation; CF, cystic fibrosis; FEV 1 , forced expiratory volume in 1 second; FDA, Food and Drug Administration; MIC, minimal inhibitory concentration. APPROVED INDICATION FOR TOBRAMYCIN SOLUTION FOR INHALATION (TOBI)TOBI is approved for maintenance therapy of patients with cystic fibrosis (CF) who are known to be colonized with Pseudomonas aeruginosa. The results of 2 randomized, double-blind, placebo-controlled, multicentered, 24-week clinical studies demonstrated the favorable effects of this therapy. 1,2 Each study enrolled subjects 6 years or older who had Ն25% and Յ75% of predicted forced expiratory volume in 1 second (FEV 1 ). Subjects with serum creatinine concentrations above 2 mg/dL and those colonized with Burkholderia cepacia were excluded. Study participants received alternating 28-day cycles of drug therapy. Two hundred fifty-eight patients received 300 mg of TOBI twice daily and 262 received inhaled saline placebo. Both drug and placebo were delivered by a PARI LC Plus nebulizer (PARI Respiratory Equipment Inc, Monterey, CA) with a Pulmo-Aide compressor (DeVilbiss Air Power Co, Jackson, TN). The drug recipients experienced significant improvement in pulmonary function compared with the placebo recipients; the average improvement in FEV 1 at the end of the study (week 24) relative to baseline (week 0) was 7% to 11% in the treatment group versus 0% to 1% in the placebo group (P Ͻ .001). Furthermore, TOBI resulted in a significant reduction...

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“…Preventing this colonisation is considered the most important challenge for the CF clinician, as it frequently determines the patient's future quality of life and long-term survival (CF Trust 2002;Koch, 2002). The current approach relies on two strategies (Frederiksen et al, 1999): i) paying attention to segregate patients on bacteriological grounds in order to limit the risk of cross-infections (West et al, 2002;Conway et al, 2008), ii) early antibiotic treatment at the time of the first PA colonisation (Littlewood et al, 1985;Valerius et al, 1991;Frederiksen et al, 1997;Lee et al, 2004). A number of regimens have been evaluated (Stuart et al, 2010) but there is no consensus about the best combination, dosage, or length of treatment course.…”

Section: Challenge 1: Postpone Chronic Colonisation By Pseudomonas Aementioning

confidence: 99%

The Prognosis of Cystic Fibrosis - A Clinician's Perspective

Lebecque¹

2012

Cystic Fibrosis - Renewed Hopes Through Research

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Nebulised Colomycin for Early Pseudomonas Colonisation in Cystic Fibrosis

Cited by 192 publications

References 4 publications

Antibiotic therapy against Pseudomonas aeruginosa in cystic fibrosis: a European consensus

Antibiotic therapy against Pseudomonas aeruginosa in cystic fibrosis: a European consensus

Technical Report: Precautions Regarding the Use of Aerosolized Antibiotics

The Prognosis of Cystic Fibrosis - A Clinician's Perspective

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