Project name: Project category: Kind of research: Country: Principle investigator:

Intravenous Colistin use in Cystic Fibrosis patients: Pilot study of pharmacokinetics, pharmacodynamics, tolerance profile and risk of selection of resistance

Clinical research Belgium Prof. Dr. Christiane Knoop
Start date: 01/01/2017
End date: 31/12/2018
Status: Ongoing

Cystic fibrosis (CF) lung disease is characterized by the progressive development of bronchiectasis superinfected by bacterial and/or fungal pathogens resulting in progressive destruction of functional lung tissue and is the main cause of morbidity and mortality in patients afflicted by this disease.

Chronic colonization with Pseudomonas aeruginosa (Pa) is associated with a more severe course of CF lung disease. Inhaled, oral or intravenous anti-pseudomonal antibiotic treatment is, thus, a pillar of treatment in Pa colonized CF patients. Over time though, with repeated antibiotic courses, there is a risk of selecting multi-resistant Pa strains and in some patients intravenous (iv) colistin represents a last resort drug.

CF patients present specific antibiotic pharmacokinetic and pharmacodynamic profiles because of their peculiar body composition. For many antibiotics, including colistin, data describing the optimal antibiotic dosage to be used in these patients are lacking.

The primary objective of our study is to assess pharmacokinetic and pharmacodynamic parameters of iv colistin in adult CF patients infected by multi-resistant Pa strains. The secondary aim is to correlate these data with efficacy parameters and toxic side effects. In parallel, Pa strains will also be tested in vitro for their capacity to produce biofilms and to develop resistance to colistin.

We hope to determine the most appropriate dose of iv colistin to be administered to CF patients in terms of efficacy, safety, and minimization of the risk of selecting resistant strains.

Researcher: Prof. Dr. Frederic Cotton, Prof. Dr. Olivier Denis, Dr. Maya Hites, Dr. Jean Michel Hougardy
Institute: Hôpital Erasme (Université Libre de Bruxelles)
City: Brussels
Project amount (€): 150.000

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