A randomised, prospective double-blind trial of long-term daily versus weekly azithromycin in cystic fibrosis

Phase 4

Active, not recruiting

• Conditions: Cystic Fibrosis; Human Genetics and Inherited Disorders - Cystic fibrosis

• Registration Number: ACTRN12605000162617
• Lead Sponsor: Associate Professor Joseph McCormack, University of Queensland, Department of Medicine, Mater Hospital, South Brisbane, 4101

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Consenting children and adults (age >/6 years; weight >/ 25kg) with Clinically stable (at least 2 weeks since last acute IV/oral antibiotic therapy; FEV1 within 10% of average for last 6 months).

Exclusion Criteria

Inability to provide written informed consent. Patients with a known allergy to macrolides. Patients taking terfenadine (Teldane), zidovudine (AZT), digoxin (Lanoxin), cyclosporin (Neroal). Patients taking any macrolide antibiotics in the 8 weeks prior to enrolment. Atypical mycobacteria infection of clinical significance. Commencement of anti-inflammatory therapy or mucolytic therapy in the month prior to enrolment, or during the duration of the study. Patient or their partner pregnant, or planning to become pregnant in the next 6 months. Patients with known liver impairment: portal hypertension or proven liver cirrhosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in FEV1 % predicted.[Measured at baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment)]

Secondary Outcome Measures

Name	Time	Method
Antibiotic use[All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment)]; Hospital days[All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment).];BMI,[All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment).];QOL[All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment).];CRP levels[All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment).];Cytokine response and bacteriology[All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment).]