An open-label study to evaluate the safety and tolerability of inhaled Teicoplanin in the treatment of Staphylococcus aureus (including mrsa) infections in cystic fibrosis patients

Trial details

Who runs it

Azienda Ospedaliera Universitaria Integrata Verona

Trial code

EU 2024-517820-21-00

Record updated

2024. október 7.

Original description

The primary objective of the study is to determine the safety and tolerability of inhaled teicoplanin in patients suffering from cystic fibrosis associated to persistent Staphylococcus aureus (including MRSA) infection treated with the drug at a dosage of 200 mg/3ml BID for two cycles of 28 days separated by 28 days without treatment.Read full original descriptionShow less

The primary objective of the study is to determine the safety and tolerability of inhaled teicoplanin in patients suffering from cystic fibrosis associated to persistent Staphylococcus aureus (including MRSA) infection treated with the drug at a dosage of 200 mg/3ml BID for two cycles of 28 days separated by 28 days without treatment.

Inclusion: Male or female patients, aged ≥12 years with a confirmed diagnosis of Cystic Fibrosis and persistent Staphylococcus aureus (including MRSA) infection (≥3 positive culture of Staphylococcus aureus (including MRSA) in sputum within the 24 months prior to enrollment); Patients with FEV1 ≥ 50% and ≤ 90% of predicted; Patients able to understand the nature of the study and willing to comply with the protocol requirements; Patients who (or if < 18 years of age, whose guardians) have signed written informed consent to participate to the study after benefits and risks have been fully explained.

Exclusion: Patients with known episodes of bronchoconstriction after drug inhalation; Ongoing or prior participation in an investigational drug study within 28 days of the Screening Visit. A washout period of 5 terminal half-lives of the previous investigational study drug, or 28 days, whichever is longer, must elapse before the Screening Visit; Patients under treatment with Kaftrio+Kalydeco for less than 6 consecutive months; Patients lung transplanted and on the waiting list for lung transplantation; Patients treated with nebulized or systemic vancomycin or teicoplanin within 8 weeks before the study enrollment; Patients with chronic Pseudomonas aeruginosa and Bulkholderia cepacia infections will be excluded from the study because it is known that these pathogens cause progressive loss of lung function and requires the administration of inhaled antibiotics. Patients with colonization by others Gram – are instead elegible; Patients with medical history of hemoptysis (> 300 cc in 30 days); Patients with known or suspected allergy or hypersensitivity to glycopeptides or other antibiotics or to any of the excipients; Abnormal laboratory findings or other findings or medical history at Screening that, in the Investigator's opinion, would compromise the safety of the subject or the quality of the study data; Patients with decreased liver function (AST or ALT > 3 times higher in comparison to reference values); Patients with renal insufficiency (those with eGFR < 15 mL/min/1.73 sqm calculated using the Schwartz formula, which then correspond to CKD V); Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for one months later; Patients with inability to tolerate inhaled products.

EU CTIS 2024-517820-21-00