ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2009-014042-28-GB
Date of registration:	14/10/2010
Prospective Registration:	No
Primary sponsor:	Imperial College, London
Public title:	What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosis
Scientific title:	What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosis
Date of first enrolment:	16/10/2009
Target sample size:	240
Recruitment status:	Authorised-recruitment may be ongoing or finished
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014042-28
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Comparing with usual clinical practice of 14 days
Phase:

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion 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:
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.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

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
Concentration type: up to
Concentration number: 50-

Trade Name: Ceftazidime
Product Name: Ceftazidime
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Ceftazidime
CAS Number: 72558-82-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 200-

Trade Name: Tobramycin
Product Name: Tobramycin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tobramycin
CAS Number: 32986-56-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 40-

Primary Outcome(s)

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?

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

Secondary Objective:

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.