CIPROFLOXACIN for Bronchiectasis

Inclusion criteria

• {"criterion_text":"- ≥18 years of age\n- Diagnosis of bronchiectasis on thoracic CT-scan\n- Isolation of PA in a respiratory sample (spontaneous or induced sputum or other lower respiratory tract sample obtained by bronchoscopy) taken no more than 3 months prior to randomisation, and if this sample was taken more than 4 weeks (28 days) prior to the planned randomisation date, a new respiratory sample must have been taken and confirmed the persistence of PA prior to randomisation.\n- Patient either Pseudomonas naive (i.e., never previously isolated PA) or Pseudomonas free (i.e., infection-free for ≥1 year, proven by at least two PA negative respiratory sample during the last year)\n- Patient affiliated with the French health care system\n- Able to understand and sign a written informed consent form"}

Exclusion criteria

• {"criterion_text":"- Confirmed diagnosis of cystic fibrosis\n- Active cancer or haematological malignancy under active therapy\n- Systemic corticosteroid therapy ≥ 20 mg/d. prednisone equivalent for a predictable duration > 4 weeks\n- Non-tuberculous mycobacterial infection or positive non-tuberculous mycobacterial respiratory specimen within 1 year prior to inclusion\n- Severe chronic renal failure defined by a creatinine clearance (Cockcroft or MDRD) ≤ 30 mL/min/1.73m2 or chronic haemodialysis\n- Long-term oxygen therapy and/or noninvasive mechanical ventilation for chronic respiratory insufficiency (except continuous positive airway pressure for OSA) and/or forced expiratory volume at one second (FEV1) <25% of predicted value\n- Patient participating to another interventional clinical trial\n- Pregnancy or breastfeeding\n- P. aeruginosa resistant to ciprofloxacin or ceftazidime\n- Women of childbearing potential (following menarche and until becoming post-menopausal unless permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)) who refuse to use effective contraception (hormonal or mechanical) for 3 months and/or to undergo pregnancy tests at baseline, 1 month and 3 months after baseline\n- Isolation of P.Aeruginosa (PA) in a respiratory specimen (spontaneous or induced sputum or other lower respiratory tract specimen obtained by bronchoscopy) more than 3 months to 12 months prior to randomization\n- Severe exacerbation requiring admission to an intensive care unit (e.g. for non-invasive ventilatory support, invasive mechanical ventilation, catecholamine or any other organ supportive therapy)\n- Acute liver failure\n- Prior severe reaction, hypersensitivity reaction or other contraindication to any of the treatments in study (ciprofloxacin, beta-lactam, colistimethate sodium)\n- Prior severe bronchospasm attributed to a nebulization\n- Patients already receiving PA suppressive therapy with an inhaled antibiotic (long-term azithromycin therapy accepted)\n- Prior PA-eradication antibiotic treatment (systemic antibiotic(s) active against PA for ≥ 14 days or nebulized anti-PA antibiotic) within the last year\n- Antibiotic treatment active against PA (anti-PA beta-lactam antibiotic and/or FQ and/or aminoglycoside) for more than 3 days before randomisation\n- Protected person (pregnant woman, nursing mother, person under guardianship, minor, person deprived of liberty, person unable to give consent)\n- Patient who has already taken part in the ANTEIPA study"}

Primary endpoints

• {"endpoint_text":"- PA-eradication rate 6 months after the start of antibiotic therapy targeting PA","definition_or_measurement_approach":"PA-eradication rate assessed 6 months after the start of antibiotic therapy targeting Pseudomonas aeruginosa."}

Secondary endpoints

• {"endpoint_text":"- Exacerbation assessment at each follow-up visit, with time (in days) between the start of antibiotic therapy against PA and first exacerbation","definition_or_measurement_approach":"Time in days between the start of antibiotic therapy targeting PA and the first exacerbation; exacerbation assessment at each follow-up visit."}
• {"endpoint_text":"- Exacerbation assessment at each follow-up visit","definition_or_measurement_approach":"Assessment of exacerbation rate at 1 year (recorded at follow-up visits)."}
• {"endpoint_text":"- Quality-of-life and treatment burden assessment using questionnaires, Quality of Life-Bronchiectasis (QOL-B), Bronchiectasis Impact Measure (BIM), Treatment Burden Questionnaire (TBQ) (+ EQ-5D-5L questionnaire for the medico-economic analysis)","definition_or_measurement_approach":"Quality of life and treatment burden measured using QOL-B, BIM, TBQ and EQ-5D-5L for medico-economic analysis at specified time points (3 months and 1 year as per objectives)."}
• {"endpoint_text":"- Detection of PA at 3-month and 1 year","definition_or_measurement_approach":"Microbiological detection of Pseudomonas aeruginosa in respiratory samples at 3 months and 1 year."}
• {"endpoint_text":"- PA-recurrence in sputum (or lower respiratory tract sample, if clinically justified), with time (in days) between the start of antibiotic therapy against PA and first PA-recurrence","definition_or_measurement_approach":"Time in days from start of PA-targeting antibiotic therapy to first documented PA recurrence in sputum or lower respiratory tract sample."}
• {"endpoint_text":"- Analysis of PA (or other bacteria) susceptibility to ciprofloxacin, if growing on respiratory sample(s) performed between 3 months and 12 months","definition_or_measurement_approach":"Microbiological susceptibility testing of PA (or other bacteria) to ciprofloxacin on respiratory samples obtained between 3 and 12 months."}
• {"endpoint_text":"- AE and serious AEs will be recorded during medical interviews and by self-report in the study booklet up to 4 months after the start of treatment","definition_or_measurement_approach":"Adverse events and serious adverse events collected via medical interviews and participant self-report in study booklet up to 4 months after treatment start."}
• {"endpoint_text":"- Number of premature ending of one of the treatment in study due to any AE. Compliance to treatment and AEs will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days)","definition_or_measurement_approach":"Number of premature treatment discontinuations due to any adverse event; compliance and AEs recorded during treatment period."}
• {"endpoint_text":"- Number of premature ending of one of the treatment in study. Compliance to treatment will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days)","definition_or_measurement_approach":"Count of premature treatment discontinuations; compliance recorded during treatment period."}
• {"endpoint_text":"- Proportion of non-administered doses of nebulized colistin.Compliance to treatment will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days)","definition_or_measurement_approach":"Proportion of doses of nebulized colistin not administered; compliance recorded by interview and self-report during treatment period."}
• {"endpoint_text":"- Total cost in each group, total quality adjusted life years (QALYs) in each group, difference in costs /difference in QALYs","definition_or_measurement_approach":"Health economic endpoints: total cost and total QALYs per group and incremental cost-effectiveness ratio at 1 year."}

France

Earliest CTIS Part Ii Submission Date

05-02-2024

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

749

Number Of Sites

22

Number Of Participants

196

Primary sponsor

Full Name

Centre Hospitalier Intercommunal Creteil

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France