Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

• Sponsor: Imperial College London (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01044719
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 3
• Duration (Months): 14.9
• Patients Per Site Per Month: 16.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Drug: Ceftazidime; Drug: Tobramycin; Drug: Meropenem	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Oct 1, 2010
• Anticipated Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 10 days	Drug: Ceftazidime; Ceftazidime 2g TDS IV; Drug: Tobramycin; Tobramycin 7mg/kg/day OD IV; Drug: Meropenem; Meropenem 2g TDS IV
Active Comparator: 14 days	Drug: Ceftazidime; Ceftazidime 2g TDS IV; Drug: Tobramycin; Tobramycin 7mg/kg/day OD IV; Drug: Meropenem; Meropenem 2g TDS IV
Active Comparator: 21 days	Drug: Ceftazidime; Ceftazidime 2g TDS IV; Drug: Tobramycin; Tobramycin 7mg/kg/day OD IV; Drug: Meropenem; Meropenem 2g TDS IV

Outcome Measures

Primary Outcome Measures

1. Treatment failure at completion of antibiotic course [21 days]

2. Time to next exacerbation [6 months]

Secondary Outcome Measures

1. Change in Spirometry [up to 21 days]

2. Change in inflammatory markers [up to 21 days]

3. Change in sputum bacteriology [up to 21 days]

4. Adverse effects of study antibiotics [Up to 21 days]

5. Quality of life scores [Up to 21 days]

6. Change in nutritional status [up to 21 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cystic Fibrosis, Royal Brompton Hospital	London		United Kingdom	Sw3 6NP

Sponsors and Collaborators

• Imperial College London

Investigators

• Principal Investigator: Margaret Hodson, MD FRCP DA, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01044719
• Other Study ID Numbers: RBHADS001
• First Posted: Jan 8, 2010
• Last Update Posted: Apr 13, 2010
• Last Verified: Apr 1, 2010

• Additional relevant MeSH terms: Cystic Fibrosis; Fibrosis; Meropenem; Tobramycin; Ceftazidime

Study Results

No Results Posted as of Apr 13, 2010