Clinical trials: Pseudomonas Infection
Pneumonia
Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas…
- Trial name
- PRISM-MDR (NCT03409679)
- Testing
- Murepavadin, Two anti-pseudomonal antibiotics
- Where
- 61 sites in United States, Brazil and 11 more
- Volunteers
- 41 people
- Sponsor
- Polyphor Ltd.
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.
Pseudomonas Infection
Cipro Inhaler for Cystic Fibrosis Children Ages 6-12
Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation.
- Trial name
- NCT00910351
- Testing
- Ciprofloxacin (Cipro, BAYQ3939)
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- Bayer
Pseudomonas Aeruginosa, Cystic Fibrosis
Open Label Extension to Bridging Study CTBM100C2303
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas…
- Trial name
- NCT00982930
- Testing
- Tobramycin inhalation powder
- Where
- 2 sites in Estonia, Russia
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Infections, Pseudomonas Aeruginosa
Second Open Label Extension to Bridging Study CTBM100C2303
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were…
- Trial name
- NCT01069705
- Testing
- Tobramycin inhalation powder
- Where
- 17 sites in Bulgaria, Estonia and 5 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis
Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa
The purpose of the study was to evaluate lung clearance index (LCI) by a standardized procedure in a well characterized study setting and to assess feasibility of LCI as a more sensitive method than forced expiratory volume at 1…
- Trial name
- ELIXIR (NCT02248922)
- Testing
- TIS or TIP
- Where
- 6 sites in Germany
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection.
- Trial name
- KB001-A (NCT01695343)
- Testing
- KB001-A
- Where
- 67 sites in United States, Australia and 2 more
- Volunteers
- 182 people
- Sponsor
- Humanigen, Inc.
Cystic Fibrosis
Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection
The purpose of this study is to evaluate the safety and efficacy of 2 dose combinations of fosfomycin/tobramycin for inhalation (FTI), following a 28-day course of Aztreonam for Inhalation (AZLI) in patients with cystic fibrosis…
- Trial name
- NCT00794586
- Testing
- FTI, AZLI
- Where
- 36 sites in United States
- Volunteers
- 120 people
- Sponsor
- Gilead Sciences
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, Lung Infection
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second…
- Conditions
- Cystic Fibrosis, Lung Infection, Pseudomonas Aeruginosa
- Trial name
- AIR-CF4 (NCT00712166)
- Testing
- AZLI 75 mg three times daily (TID)
- Where
- 40 sites in United States, Australia and 1 more
- Volunteers
- 160 people
- Sponsor
- Gilead Sciences
Pseudomonas Aeruginosa, Ventilator Associated Pneumonia
Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa
Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals.
- Trial name
- NCT00691587
- Testing
- KB001
- Where
- France
- Volunteers
- 36 people
- Sponsor
- Humanigen, Inc.
Cystic Fibrosis
A Cross-over Study of OligoG in Subjects With Cystic Fibrosis. Fibrosis
The purpose of this study is to determine the safety and local tolerability of multiple dose administration of inhaled OligoG in CF subjects.
- Trial name
- OligoG (NCT01465529)
- Testing
- OligoG CF-5/20, Saline
- Where
- 3 sites in Ireland, United Kingdom
- Volunteers
- 26 people
- Sponsor
- AlgiPharma AS
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
Cystic Fibrosis
Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)
- Trial name
- NCT00638365
- Testing
- KB001
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Humanigen, Inc.
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
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF3 (NCT00128492)
- Testing
- AZLI 75 mg two times a day (BID)/ three times a day (TID)
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF)…
- Trial name
- NCT00558844
- Testing
- Arikayce™ 560 mg, Arikayce™ 70 mg, Arikayce™ 140 mg
- Where
- 19 sites in United States
- Volunteers
- 41 people
- Sponsor
- Insmed Incorporated
Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa…
- Trial name
- ALPINE 2 (NCT03219164)
- Testing
- AZLI
- Where
- 53 sites in United States, Austria and 10 more
- Volunteers
- 149 people
- Sponsor
- Gilead Sciences
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.
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