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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06368804
Other study ID # ANTEIPA
Secondary ID 2022-A01575-38
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2028

Study information

Verified date April 2024
Source Centre Hospitalier Intercommunal Creteil
Contact Camille JUNG
Phone 0157022268
Email camille.jung@chicreteil.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis. Current guidelines suggest the prescription of an eradication antibiotic treatment for a first episode of PA infection (early PA infection). Several antibiotic regimens may be proposed, ranging from a monotherapy with oral fluoroquinolone (FQ) to an intravenous cotherapy with the addition of inhaled antibiotics that seems to improve the rate of PA eradication. As no study strictly favoured one regimen, current practices are heterogeneous and could certainly benefit from stronger evidence, with both medical and economic impact.


Description:

According to current knowledge, the early combination of an oral FQ to an inhaled antibiotic could be an acceptable alternative to a systemic cotherapy. Indeed, such regimen allows avoiding IV drugs use, facilitating ambulatory management and influencing patient's quality of life and costs, and may achieve similar PA-eradication rate.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 196
Est. completion date June 1, 2028
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - =18 years of age - Diagnosis of bronchiectasis on thoracic CT-scan - Recent isolation of P. aeruginosa (PA) in a respiratory sample (spontaneous or induced sputum or other lower respiratory tract sample obtained by bronchoscopy) within the last 3 months, with a PA positive respiratory sample obtained = 3 weeks before randomization - 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) - Patient affiliated with the French health care system - Able to understand and sign a written informed consent form Exclusion Criteria: - Confirmed diagnosis of cystic fibrosis - Pregnancy or breastfeeding - Women of childbearing potential (after the first menstrual period and until menopause or permanent sterility (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. - Isolation of 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. - PA resistant to ciprofloxacin or ceftazidime - 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) - Prior severe reaction, hypersensitivity reaction or other contraindication to any of the treatments in study (ciprofloxacin, beta-lactam, colistimethate sodium) - Prior severe bronchospasm attributed to a nebulization - Patients already receiving PA suppressive therapy with an inhaled antibiotic (long-term azithromycin therapy accepted) - Prior PA-eradication antibiotic treatment (systemic antibiotic(s) active against PA for = 14 days or nebulized anti-PA antibiotic) within the last year - Antibiotic treatment active against PA (anti-PA beta-lactam antibiotic and/or FQ and/or aminoglycoside) for more than 3 days before randomisation - Active cancer or haematological malignancy under active therapy - Systemic corticosteroid therapy = 20 mg/d. prednisone equivalent for a predictable duration > 4 weeks - Non-tuberculous mycobacterial infection or positive non-tuberculous mycobacterial respiratory specimen within 1 year prior to inclusion - Severe chronic renal failure defined by a creatinine clearance (Cockcroft or MDRD) = 30 mL/min/1.73m2 or chronic haemodialysis - Severe hepatic impairment - 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. - Patient participating to another interventional clinical trial

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Antibiotic monotherapy treatment and follow-up
a 3-months treatment period, including: an initial phase of 14 days, combining an oral fluoroquinolone (ciprofloxacin 750mg tw/d) with nebulized sodium colistimethate (1 Million Units tw/d) a maintenance phase of 2.5 months: nebulized sodium colistimethate (1 MU tw/d) ; a subsequent follow-up period of 9 months (i.e. until 12 months after the start of antibiotic therapy against Pseudomonas aeruginosa).
Antibiotic bitherapy treatment and follow-up
a 3-months treatment period, including: an initial phase of 14 days, combining an IV beta-lactam antibitic (ceftazidime 4 or 6g/d) and an oral fluoroquinolone (ciprofloxacin 750mg tw/d) with nebulized sodium colistimethate (1 Million Units tw/d) a maintenance phase of 2.5 months: nebulized sodium colistimethate (1 MU tw/d) ; a subsequent follow-up period of 9 months (i.e. until 12 months after the start of antibiotic therapy against Pseudomonas aeruginosa).

Locations

Country Name City State
France CHU Amiens-Picardie Amiens
France CHU Haut Leveque, Bordeaux Bordeaux
France CHRU Brest Brest
France CH Pontoise Cergy-Pontoise
France APHP, Henri Mondor Créteil
France Centre hospitalier intercommunal de Créteil Créteil
France Hôpital de la Croix Rousse, HCL, Lyon Lyon
France CHU Nantes Nantes
France CHU H. Pasteur, Nice Nice
France APHP, Cochin Paris
France APHP, Saint Louis Paris
France APHP, Tenon Paris
France Hôpital Foch, Suresnes Suresnes
France CHU H. Larrey, Toulouse Toulouse
France CH Versailles Versailles
France CH Villefranche s/Saône Villefranche-sur-Saône

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary PA-eradication rate PA-eradication rate 6 months after the start of antibiotic therapy targeting PA, where PA eradication is defined as follows:
Sputum culture (or lower airway specimen culture, if respiratory exacerbation* with inability to perform good quality sputum analysis) negative for PA at the 6-month follow-up visit, or
Inability to spit in the absence of a pulmonary exacerbation*, AND
No sputum culture or lower airway specimen positive for PA between D90 of antibiotic treatment and the 6-month follow-up visit, in the absence of new antibiotic therapy targeting PA.
6 months
Secondary Time to first exacerbation exacerbation assessment at each follow-up visit, with time (in days) between the start of antibiotic therapy against PA and first exacerbation 3, 6 and 12 months-follow up visit, or additional visit
Secondary 1 year-exacerbation rate exacerbation assessment at each follow-up visit 3, 6 and 12 months-follow up visit
Secondary Quality-of-life using questionnaires Quality of Life-Bronchiectasis (QOL-B) Inclusion, 3 and 12 months-follow up visit
Secondary Quality-of-life using questionnaires Bronchiectasis Impact Measure (BIM) Inclusion, 3 and 12 months-follow up visit
Secondary Treatment burden assessment using questionnaires Treatment Burden Questionnaire (TBQ) Inclusion, 3 and 12 months-follow up visit
Secondary Quality-of-life using questionnaires EQ-5D-5L questionnaire for the medico-economic analysis Inclusion, 3 and 12 months-follow up visit
Secondary Detection of PA at 3-month and 1 year Sputum (or lower respiratory tract sample, if clinically justified) culture growing PA 3 and 12 months-follow up visit
Secondary Time to first PA-recurrence 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 3, 6 and 12 months-follow up visit
Secondary Emergence of FQ-resistant strains of (PA or other bacteria) analysis of PA (or other bacteria) susceptibility to ciprofloxacin, if growing on respiratory sample(s) performed between 3 months and 12 months 3, 6 and 12 months-follow up visit
Secondary Adverse event (AE) and serious AE at 12 months follow-up AE and serious AEs will be recorded during medical interviews and by self-report in the study booklet during the study during the 12 months follow-up
Secondary 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) 1 months and 3 months-follow up visit
Secondary 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) 1 months and 3 months-follow up visit
Secondary 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) 1 months and 3 months-follow up visit
Secondary Cost and incremental cost effectiveness ratio at 1 year Total cost in each group Inclusion and each follow up visit up to one year for quality of life measures; initial discharge and subsequent exacerbation-related readmissions up to one year.
Secondary Cost and incremental cost effectiveness ratio at 1 year Total quality adjusted life years (QALYs) in each group Inclusion and each follow up visit up to one year for quality of life measures; initial discharge and subsequent exacerbation-related readmissions up to one year.
Secondary Cost and incremental cost effectiveness ratio at 1 year Difference in costs /difference in QALYs Inclusion and each follow up visit up to one year for quality of life measures; initial discharge and subsequent exacerbation-related readmissions up to one year.
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