Trial of Therapy for the first pulmonary infection by Pseudomonas aeruginosa in Cystic Fibrosis.

Phase 1

• Conditions: First Pseudomonas aeruginosa infection in patients with cystic fibrosis; MedDRA version: 20.0Level: LLTClassification code 10021860Term: Infection Pseudomonas aeruginosaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2009-012575-10-IT
• Lead Sponsor: IVERSITY OF LIVERPOO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-04-10
• Study Start: 2022-01-18
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

1. Diagnosis of cystic fibrosis
2. Children over the age of 28 days, older children and adult CF participants are all eligible with no upper age limitation.
3. Competent adults should provide fully informed written consent to participate in the trial
4. Minors should have proxy consent by the parent or legal guardian and should provide assent where applicable to participate in the trial
5. The participant should have isolated P. aeruginosa and should be either:
a. P. aeruginosa -naïve (i.e. has never previously isolated P. aeruginosa) or
b. P. aeruginosa -free (i.e. any cough or sputum samples within the previous year (365 days) should be P. aeruginosa free)
6. The participant should be able to commence treatment no later than 21 days from the date of a P. aeruginosa positive microbiology report.
Are the trial subjects under 18? yes
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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Antibiotic resistance of the current P. aeruginosa sample to any of: ciprofloxacin, ceftazidime, tobramycin or colistin reported by local microbiology laboratory lab
2. Known participant hypersensitivity to either ciprofloxacin, ceftazidime, tobramycin or colistin
3. Other known contraindications to any of ciprofloxacin, ceftazidime, tobramycin or colistin, including previous aminoglycoside hearing or renal damage
4. Participant receiving P. aeruginosa suppressing treatment, in particular nebulised colistin or tobramycin, or oral ciprofloxacin for the previous nine calendar months. Please note, short courses of oral ciprofloxacin or intravenous antibiotics (with an anti-pseudomonal spectrum of action) are not an exclusion unless they are given to treat proven infections with P. aeruginosa
5. Treatment with other anti-pseudomonal nebuliser
6. Pregnant and nursing mothers (women of child bearing age will be counselled on the risks of becoming pregnant during the trial and will be offered a pregnancy test)
7. Previous randomisation in TORPEDO-CF study
8. Previous participation in another related intervention trial within four weeks of taking part in TORPEDO-CF

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether fourteen days intravenous ceftazidime with tobramycin is superior to three months (12 weeks)* oral ciprofloxacin. Both treatment regimes will be in conjunction with three months (12 weeks)* nebulised colistin.;Secondary Objective: To remain infection free through to 15 months after the start of allocated treatment.;Primary end point(s): Successful eradication of P. aeruginosa infection three months after allocated treatment has started, remaining infection free through to 15 months after the start of allocated treatment.;Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to recurrence of original P. aeruginosa infection; Re-infection with a different genotype of P. aeruginosa; Lung function - FEV1 , FVC, FEF25-75; O2 saturation; Growth and nutritional status – height, weight and body mass index; Number of pulmonary exacerbations; Admission to hospital; Quality of life (CFQ); Adverse events; Other sputum/cough Microbiology (Methicillin resistant Staphylococcus aureus (MRSA), Burkholderia cepacia complex, Aspergillus, Candida Infection); Cost per patient (from NHS perspective);Timepoint(s) of evaluation of this end point: every 3 months; every 3 months; every 3 months; every 3 months; every 3 months; every 3 months; every 3 months; every 3 months; every 3 months; every 3 months; every 3 months