Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

Imperial College London

Status and phase: Unknown; Phase 4

Conditions: Cystic Fibrosis

Treatments: Drug: Meropenem; Drug: Tobramycin; Drug: Ceftazidime

Study type: Interventional

Funder types: Other

Identifiers

NCT01044719

RBHADS001

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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240 participants in 3 patient groups

10 days

Active Comparator group

Treatment:

Drug: Meropenem

Drug: Ceftazidime

Drug: Tobramycin

14 days

Active Comparator group

Treatment:

Drug: Meropenem

Drug: Ceftazidime

Drug: Tobramycin

21 days

Active Comparator group

Treatment:

Drug: Meropenem

Drug: Ceftazidime

Drug: Tobramycin