Cystic Fibrosis
Conditions
Interventions
Trade Name: Meropenem
Product Name: Meropenem
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Meropenem
CAS Number: 119478-56-7
Concentration unit: mg/ml milligram(s)/millilitre
Concent
Sponsors
Imperial College, London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of cystic fibrosis (sweat test and/or gene typing). All patients attending the adult CF unit for treatment for an infective exacerbation of cystic fibrosis caused by Pseudomonas aeruginosa. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if any of the following apply: -unable to give consent -allergy to tobramycin and/or both meropenem and ceftazidime -intolerance of aminoglycoside antibiotics -Pseudomonas resistant to both meropenem and ceftazidime. -on the active transplant list or baseline FEV1 <20% predicted -pregnancy or breast-feeding -co-existent active allergic bronchopulmonary aspergillosis requiring a change in steroid or antifungal therapy -co-existent mycobacterial infection -a previous participant in this study No patient will be excluded on the basis of disability (unless their disability is such to prevent them giving proper informed consent), gender, race, ethnic origin or nationality, religion or belief, or sexual orientation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: What is the optimal duration for an antibiotic course to treat an infective exacerbation of cystic fibrosis caused by the organism Pseudomonas aeruginosa?;Secondary Objective: ;Primary end point(s): We have two primary outcome measures, a short term and a long term outcome measure. Short term primary outcome measure: Treatment success/failure at completion of the antibiotic course Long term primary outcome measure: Time to next exacerbation for those deemed a treatment success at the end of the antibiotic course | — |
Countries
United Kingdom
Outcome results
None listed