Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01044719
• Other study ID #: RBHADS001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 14, 2009
• Last updated: April 12, 2010
• Start date: January 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2010
• Source: Imperial College London
• Contact: Andrew Jones, MB BChir MRCP
• Phone: 02073518940
• Email: andrew.jones1[@]imperial.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

Cystic Fibrosis patients attending with infective exacerbations will be enrolled into the study. The trial is a double blinded, randomised trial with patients randomised to 10,14 or 21 days of antibiotic therapy, comprising of tobramycin and either ceftazidime or meropenem.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: April 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 16 years or older

• Diagnosis of Cystic Fibrosis

• Presenting with Infective exacerbation

Exclusion Criteria:

• Unable to give consent

• Allergy to study medications

• Intolerance of aminoglycoside antibiotics

• Pseudomonas resistant to study antibiotics

• On the active transplant list or FEV1<20% predicted

• Pregnancy/breast-feeding

• Co-existent ABPA requiring a change in treatment

• Co-existent mycobacterial infection

• A previous participant in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Ceftazidime
Ceftazidime 2g TDS IV
• Tobramycin
Tobramycin 7mg/kg/day OD IV
• Meropenem
Meropenem 2g TDS IV

Locations

Country	Name	City	State
United Kingdom	Department of Cystic Fibrosis, Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure at completion of antibiotic course		21 days	No
Primary	Time to next exacerbation		6 months	No
Secondary	Change in Spirometry		up to 21 days	No
Secondary	Change in inflammatory markers		up to 21 days	No
Secondary	Change in sputum bacteriology		up to 21 days	No
Secondary	Adverse effects of study antibiotics		Up to 21 days	Yes
Secondary	Quality of life scores		Up to 21 days	No
Secondary	Change in nutritional status		up to 21 days	No