Clinical trials: Chronic Pseudomonas Aeruginosa Infection
Cystic Fibrosis
Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase
A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P.
- Trial name
- NCT03905642
- Testing
- Arikayce™
- Where
- 11 sites in Belgium, Hungary and 5 more
- Volunteers
- 49 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis
Scandinavian Cystic Fibrosis Azithromycin Study
In patients with Cystic Fibrosis, recurrent airway infection caused by Pseudomonas aeruginosa ultimately leads to chronic airway infection.
- Trial name
- NCT00411736
- Where
- 8 sites in Denmark, Norway and 1 more
- Volunteers
- 45 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis
Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
This is a Phase 1b/2a study with the primary objective to determine if BX004-A is safe and tolerable. Exploratory objectives include whether BX004-A reduces sputum Pseudomonas aeruginosa (PsA) bacterial load in CF subjects with…
- Trial name
- NCT05010577
- Testing
- BX004-A
- Where
- 28 sites in United States, Czechia and 3 more
- Volunteers
- 43 people
- Sponsor
- BiomX, Inc.
Cystic Fibrosis, Pseudomonas Aeruginosa
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered…
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection
- Trial name
- SWARM-Pa (NCT04596319)
- Testing
- AP-PA02
- Where
- 20 sites in United States
- Volunteers
- 29 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Non Cystic Fibrosis Bronchiectasis
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic…
- Trial name
- NCT02104245
- Testing
- Ciprofloxacin dispersion for inhalation
- Where
- 95 sites in United States, Australia and 14 more
- Volunteers
- 304 people
- Sponsor
- Aradigm Corporation
Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis (CF)
Study With Phage for CF Subjects With Pseudomonas Lung Infection
The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects.
- Trial name
- NCT06998043
- Testing
- BX004
- Where
- 14 sites in United States
- Volunteers
- 63 people
- Sponsor
- BiomX Ltd
Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa
Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic…
- Conditions
- Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa, Lung Infection
- Trial name
- Tailwind (NCT05616221)
- Testing
- AP-PA02
- Where
- 23 sites in United States
- Volunteers
- 48 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
- Conditions
- Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic, Pseudomonas Aeruginosa
- Trial name
- NCT06016088
- Testing
- RSP-1502, Tobramycin inhalation solution
- Where
- 22 sites in United States, Australia
- Volunteers
- 71 people
- Sponsor
- Respirion Pharmaceuticals Pty Ltd
Cystic Fibrosis, Chronic Bronchitis
Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF)
This was a randomized multi-center clinical trial to compare the microbiological efficacy, clinical efficacy, and safety of using standard versus biofilm susceptibility testing of P.
- Trial name
- NCT00153634
- Testing
- IV amikacin, PO azithromycin, IV ceftazidime
- Where
- 8 sites in United States
- Volunteers
- 75 people
- Sponsor
- Seattle Children's Hospital
Cystic Fibrosis
Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF
The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic…
- Trial name
- AZLI CAT (NCT01641822)
- Testing
- AZLI, Tobramycin inhalation solution
- Where
- 71 sites in United States
- Volunteers
- 107 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare…
- Trial name
- CT03 Core (NCT00885365)
- Testing
- tobramycin / Bramitob, tobramycin / TOBI
- Where
- 44 sites in Czechia, France and 6 more
- Volunteers
- 324 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
P. Aeruginosa, Baumannii
An Open Clinical Trial of the Safety and Efficacy of the Drug Fluorothiazinone, 300 Mg Tablets with the Participation of Adult Patients with Chronic Bacterial Cystitis"
This study is designed to evaluate the safety, clinical efficacy and antibacterial activity of the drug Fluorothiazinone, 300 mg tablets, (Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the…
- Conditions
- P. Aeruginosa, Baumannii, Klebsiella Pneumonia, E.coli Infections
- Trial name
- NCT06815549
- Testing
- Fluorothiazinone, tablets 300 mg, Nitrofurantoin 100 MG
- Volunteers
- 280 people
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Bronchiectasis, Microbial Colonization
Role of Pseudomonas Aeruginosa Biofilms in Exacerbations in Patients With Bronchiectasis With and Without Chronic Obstructive Pulmonary Disease
Exacerbations, in particular during chronic Pseudomonas aeruginosa (PA) infection, are very important in the prognosis of patients with non-cystic fibrosis bronchiectasis (BE).
- Conditions
- Bronchiectasis, Microbial Colonization, Pseudomonas Aeruginosa, Biofilm
- Trial name
- NCT04803695
- Testing
- Microbial biofilm diagnose
- Where
- Spain
- Volunteers
- 96 people
- Sponsor
- Hospital Clinic of Barcelona
Cystic Fibrosis
Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa
The primary purpose of this study is to evaluate the safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.
- Trial name
- NCT06238856
- Testing
- SLIT™ Amikacin
- Volunteers
- 18 people
- Sponsor
- Insmed Incorporated
COPD, Respiratory Tract Infections
Targeted AntiBiotics for Chronic Pulmonary Diseases
This is a prospective, randomized multi-center trial investigating the impact of lower airway infection with P. aeruginosa in COPD patients. The aim of the study is to evaluate if targeted antibiotic therapy against P.
- Conditions
- COPD, Respiratory Tract Infections, Pseudomonas Aeruginosa, Bronchiectasis
- Trial name
- Target-ABC (NCT03262142)
- Testing
- Piperacillin/tazobactam, Ciprofloxacin
- Where
- Denmark
- Volunteers
- 51 people
- Sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Bronchiectasis
Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population.
This study aims to investigate the characteristics of gut microbiome and metabolome in non-CF bronchiectasis patients, hoping to explore the underlying mechanisms as well as the influence of gut microbiota composition on…
- Trial name
- NCT04490447
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Non Cystic Fibrosis Bronchiectasis
Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I)
The objective of the trial was to investigate the effect of the use of inhaled CMS, administered b.i.d. via a specific nebuliser for 12 months, compared to placebo in subjects with NCFB chronically infected with P.
- Trial name
- PROMIS-I (NCT03093974)
- Testing
- CMS
- Where
- 85 sites in Australia, Belgium and 10 more
- Volunteers
- 377 people
- Sponsor
- Zambon SpA
Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa
Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection
The use of inhaled medications for the treatment of pulmonary diseases allows for the delivery of a high concentration of a drug at the site of disease with reduced systemic absorption and risk of systemic adverse effects.
- Trial name
- TOBI (NCT02102152)
- Testing
- Tobramycin
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Rabin Medical Center
Bronchiectasis Adult, Bronchiectasis With Acute Exacerbation
A Rhinovirus Challenge Study to Investigate Exacerbations and Immune Responses in Bronchiectasis
The goal of this study is to determine if viral infection with the common cold leads to an exacerbation in participants with bronchiectasis.
- Conditions
- Bronchiectasis Adult, Bronchiectasis With Acute Exacerbation, Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa, Viral Infection
- Trial name
- BARRIER (NCT06931002)
- Testing
- Rhinovirus A-16 Infection
- Where
- United Kingdom
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Cystic Fibrosis
Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)
A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P.
- Trial name
- NCT00777296
- Testing
- ARIKACE™
- Where
- 11 sites in Belgium, Hungary and 5 more
- Volunteers
- 66 people
- Sponsor
- Insmed Incorporated