Informations générales (source: ClinicalTrials.gov)
Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With Pseudomonas Aeruginosa in Adults With Bronchiectasis: a Non-inferiority Randomized Controlled Trial. (ANTEIPA)
Interventional
Phase 2
Centre Hospitalier Intercommunal Creteil (Voir sur ClinicalTrials)
septembre 2024
septembre 2028
13 décembre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | PHILIPPE | 04/12/2024 13:04:44 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Clémence MARTIN | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Nathalie ROZENSTAJ | Contact (sur clinicalTrials) | |||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Charlotte COLIN | Contact (sur clinicalTrials) | |||
| CHI DE CRETEIL | Bernard MAITRE | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP, Henri Mondor - Créteil - France | Fréderic SCHLEMMER | Contact (sur clinicalTrials) | |||
| APHP, Saint Louis - Paris - France | Abdellatif TAZI | Contact (sur clinicalTrials) | |||
| CH Villefranche s/Saône - Villefranche-sur-Saône - France | Sonia BLANDIN | Contact (sur clinicalTrials) | |||
| CHRU Brest - Brest - France | Francis COUTURAUD | Contact (sur clinicalTrials) | |||
| CHU Amiens-Picardie - Amiens - France | Damien BASILLE | Contact (sur clinicalTrials) | |||
| CHU H. Larrey, Toulouse - Toulouse - France | Marlene MURIS-ESPIN | Contact (sur clinicalTrials) | |||
| CHU H. Pasteur, Nice - Nice - France | Sylvie LEROY | Contact (sur clinicalTrials) | |||
| CHU Haut Leveque, Bordeaux - Bordeaux - France | Julie MACEY | Contact (sur clinicalTrials) | |||
| CHU Nantes - Nantes - France | François-Xavier BLANC | Contact (sur clinicalTrials) | |||
| Clinique St Joseph - 13008 - Marseille - France | Cristina AUDOLY, MD | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix Rousse, HCL, Lyon - Lyon - France | Gilles DEVOUASSOUX | Contact (sur clinicalTrials) | |||
| Hôpital Foch, Suresnes - Suresnes - France | Emilie CATHERINOT | Contact (sur clinicalTrials) | |||
| Hôpital Pitié Salpêtrière - 75013 - Paris - France | Christophe CRACCO, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- ≥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
- 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