cystic fibrosis associated to persistent Staphylococcus aureus (including MRSA) infection MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0 Level: LLT Classification code 10075981 Term: Staphylococcus aureus infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: TEICOPLANINA SANDOZ - 200 MG POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE O INFUSIONE 1 FLACONCINO VETRO DA 200 MG E 1 FIALA VETRO DA 3 ML
Product Name: Teicoplanina Sandoz 200 mg
Product
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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). 2. Patients with FEV1 = 50% and = 90% of predicted. 3. Patients able to understand the nature of the study and willing to comply with the protocol requirements. 4. Patients who (or if =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with Pseudomonas aeruginosa chronic infection. 2. Patients under treatment with Kaftrio+Kalydeco for less than 6 consecutive months. 3. Patients with medical history of hemoptysis (> 300 cc in 30 days). 4. Patients with decreased liver function (AST or ALT > 3 times higher in comparison to reference values). 5. Inability to tolerate inhaled products. 6. Patients with renal insufficiency. 7. Patients lung transplanted and on the waiting list for lung transplantation. 8. Patients with known or suspected allergy or hypersensitivity to glycopeptides or other antibiotics. 9. Patients treated with nebulized or systemic vancomycin or teicoplanin within 8 weeks before the study enrollment. 10. Patients with known episodes of bronchoconstriction after drug inhalation. 11. 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. 12. Patients who are participating or have participated in other clinical studies within the 30 days before the study enrollment. 13. 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. 14. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: • to assess the degree of microbiological improvement following treatment with inhaled teicoplanin at a dosage of 200 mg/3ml BID for two cycles of 28 days separated by 28 days without treatment, measured as reduction of the Staphylococcus aureus CFUs presence in the sputum throughout the study period. • to assess the effect of the treatment with inhaled teicoplanin on the FEV1 value, in comparison to baseline. • to assess the effect of the treatment with inhaled teicoplanin on the Lung Clearance Index (LCI) value, in comparison to baseline. • to assess the effect of the treatment with inhaled teicoplanin on the plethysmography values, in comparison to baseline. • to evaluate the effect of the treatment with inhaled teicoplanin in eradicating persistent Staphylococcus aureus infection.;Primary end point(s): The primary endpoint of the study is the evaluation of safety and tolerability to 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. This will be measured as: a) decline from baseline of FEV1 value = 20% after 30 minutes from administration; b) oxygen saturation < 90% after 30 minutes from administration; c) severe coughing; d) chest tightness; e) throat discomfort; f) moderate/severe dyspnea.;Timepoint(s) of evaluation of this end point: 30 minutes from administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in bacterial load of Staphylococcus aureus in sputum as determined by CFU at baseline (Visit 2) and at Visits 5 (after 1st treatment cycle), 6 (after 2nd treatment cycle) and 9/10 (at End of Study, after follow-up period), in comparison to baseline.; Changes in pulmonary function tests as determined by FEV1 at baseline (Visit 2) and at each study visit until End of Study, in comparison to baseline.; Changes in Lung Clearance Index (LCI) measured at baseline (Visit 2) and at each study visit until End of Study, in comparison to baseline.; Changes in plethysmography values measured at baseline (Visit 2) and at the end of the treatment (Visit 5); Rate of persistent Staphylococcus aureus infection eradication among the patients being treated with the drug at a dosage of 200 mg/3ml BID for two cycles of 28 days separated by 28 days without treatment.;Timepoint(s) of evaluation of this end point: at baseline (Visit 2) and at Visits 5 (after 1st treatment cycle), 6 (after 2nd treatment cycle) and 9/10 (at End of Study, after follow-up period), in comparison to baseline.; at baseline (Visit 2) and at each study visit until End of Study, in comparison to baseline.; at baseline (Visit 2) and at each study visit until End of Study, in comparison to baseline.; at baseline (Visit 2) and at the end of the treatment (Visit 5); end of study | — |
Countries
Italy
Contacts
Public ContactUOC Fibrosi Cistica
Azienda Ospedaliera Universitaria Integrata Verona
Outcome results
None listed