Eradication of early P. aeruginosa infection in children &lt;7 years of age with cystic fibrosis: The early study

Ratjen, Félix; Moeller, Alexander; McKinney, Maureen; Asherova, I.; Alon, N.; Maykut, Robert; Angyalosi, Gerhild; Bede, Olga; Bolbás, Katalin; Булатов, В. П.; Chertok, Elena; Colombo, Carla; Fayon, Michaël; Gönczi, Ferenc; Gouda, Essam; Hammermann, J.; Munck, À.; Solomon, Melinda; Tsanakas, John

doi:10.1016/j.jcf.2018.04.002

Cited by 37 publications

(25 citation statements)

References 21 publications

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“…The first studies with colistin [96,97] demonstrated a reduction in the rate of chronic colonization with respect to placebo and fewer hospital admissions than in historic controls and small series with no control group [98]. Numerous studies have also shown the eradicative effects of tobramycin, usually administered for inhalation in solution (TIS), in on-off cycles of 28 days [93,99]. The efficacy of colistin and tobramycin has proved similar with respect to their eradication rates and effects on lung function [100,101].…”

Section: Transversalmentioning

confidence: 99%

Impact of Pseudomonas aeruginosa Infection on Patients with Chronic Inflammatory Airway Diseases

García‐Clemente

Rosa

Máiz

et al. 2020

JCM

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Pseudomonas aeruginosa (P. aeruginosa) is a ubiquitous and opportunistic microorganism and is considered one of the most significant pathogens that produce chronic colonization and infection of the lower respiratory tract, especially in people with chronic inflammatory airway diseases such as asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), and bronchiectasis. From a microbiological viewpoint, the presence and persistence of P. aeruginosa over time are characterized by adaptation within the host that precludes any rapid, devastating injury to the host. Moreover, this microorganism usually develops antibiotic resistance, which is accelerated in chronic infections especially in those situations where the frequent use of antimicrobials facilitates the selection of “hypermutator P. aeruginosa strain”. This phenomenon has been observed in people with bronchiectasis, CF, and the “exacerbator” COPD phenotype. From a clinical point of view, a chronic bronchial infection of P. aeruginosa has been related to more severity and poor prognosis in people with CF, bronchiectasis, and probably in COPD, but little is known on the effect of this microorganism infection in people with asthma. The relationship between the impact and treatment of P. aeruginosa infection in people with airway diseases emerges as an important future challenge and it is the most important objective of this review.

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Section: Transversalmentioning

confidence: 99%

Impact of Pseudomonas aeruginosa Infection on Patients with Chronic Inflammatory Airway Diseases

García‐Clemente

Rosa

Máiz

et al. 2020

JCM

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“…Table 1 describes the different definitions used for first lifetime or positive Pa culture after a stated time scale in studies aiming for Pa eradication. This includes first lifetime documented culture positive for Pa [17][18][19][20] or positive Pa culture following a negative Pa timescale for: 6 months [21][22][23], 1 year [24][25][26][27][28][29] and 2 years [30][31][32].…”

Section: Methodsmentioning

confidence: 99%

A critical review of definitions used to describe Pseudomonas aeruginosa microbiological status in patients with cystic fibrosis for application in clinical trials

Taccetti

Denton

Hayes

et al. 2020

Journal of Cystic Fibrosis

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Background: Definition of Pseudomonas aeruginosa (Pa) microbiological status is essential for patients' inclusion in clinical trials. The aim of this study was to agree on the definitions of Pa infection status for initial infection, eradication and chronic infection to be used in clinical trials and to propose additional future study areas. Methods: An exhaustive literature search was performed. The clinimetric properties of different definitions of Pa microbiological status were evaluated. Results: Historical studies have mostly used culture-based definitions, although some have also involved complementary anti-Pa antibodies. Clinimetric analysis showed great variability in the definitions used, leading to differences in reliability, validity, responsiveness to treatment and correlation with outcome measures. Use of serology for initial Pa infection and successful Pa eradication introduced a greater level of complexity as antibody tests are not standardised. Moreover, the chronology of the immune response to Pa antigenic determinants was not completely clear. Chronic Pa infection was characterized by high levels of antibodies and good concordance between culture results and serology. Conclusions: Microbiological monitoring, regular sampling from the airways and standardization of culture methods remain essential requisites for microbiological definitions. Despite limitations, serology should be incorporated in the definitions of initial infection and eradication used in clinical trials to better classify patients at enrolment, mainly in non-expectorating children. This requires standardization of serological testing.

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“…Ratjen et al [43] performed a placebo-controlled trial and compared eradication-rate of Pseudomonas aeruginosa from lung using 300 mg tobramycin inhaled twice-daily to that of placebo in children, aged < 7 years, with cystic fibrosis. On 29 th day of therapy, 84.6% children had sputum free from this organism compared to 47.8% in children who received placebo.…”

Section: Tobramycin Trials In Childrenmentioning

confidence: 99%

Clinical pharmacology of tobramycin in infants and children

Pacifici¹

2020

Clin Med Invest

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Tobramycin is an aminoglycoside antibiotic, binds to polysomes and interferes with bacterial protein synthesis causing misreading and premature termination of mRNA translation, it is bactericidal, has post-antibiotic effect on bacterial killing, and antimicrobial effect is concentration-dependent. This antibiotic may be administered orally, intravenously (either by slow injection or intravenous infusion), intramuscularly, applied to skin, and lung infections may be treated by inhalation. Tobramycin intravenous doses are: 5 mg/kg every 36 hours in infants, with a postmenstrual age < 32, and once-daily in older infants, and in children, doses are 2.5 and 3.5 mg/kg thrice-daily. Tobramycin effects are: increase of sodium excretion in the urine, tubular injury, and bronchoconstriction. This antibiotic well diffuses through all body organs, including the central nervous system, and successfully treated lung, kidney, ear, mouth, throat, eye, skin infections, rhinopharyngitis, and meningitis. Tobramycin peak and trough concentrations should be > 10 and < 2 µg/ml, respectively, in order to yield antimicrobial effect and to keep toxicity low. Optimization of treatment has been recommended in order to keep serum concentrations within the therapeutic-interval as they vary in infants and children. Tobramycin half-life is longer in infants (about 10 hours) than in children. Some organisms may become resistant to tobramycin. The aim of this study is to review published data on tobramycin dosing, efficacy, safety, effects, adverse-effects, drug-interactions, treatment optimization, trials, meningitis, pharmacodynamics, pharmacokinetics, and bacterial-resistance in infants and children.

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Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study

Abstract: NCT01082367.

Cited by 37 publications

References 21 publications

Impact of Pseudomonas aeruginosa Infection on Patients with Chronic Inflammatory Airway Diseases

Impact of Pseudomonas aeruginosa Infection on Patients with Chronic Inflammatory Airway Diseases

A critical review of definitions used to describe Pseudomonas aeruginosa microbiological status in patients with cystic fibrosis for application in clinical trials

Clinical pharmacology of tobramycin in infants and children

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Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study

Abstract: NCT01082367.

Cited by 37 publications

References 21 publications

Impact of Pseudomonas aeruginosa Infection on Patients with Chronic Inflammatory Airway Diseases

Impact of Pseudomonas aeruginosa Infection on Patients with Chronic Inflammatory Airway Diseases

A critical review of definitions used to describe Pseudomonas aeruginosa microbiological status in patients with cystic fibrosis for application in clinical trials

Clinical pharmacology of tobramycin in infants and children

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Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study