Clinical trials: Pseudomonas Infections
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
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
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
Ventilator Associated Pneumonia, Lower Respiratory Infection
Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia
To investigate the pharmacokinetic characteristics of POL7080 co-administered with SoC during 10 to 14 days of treatment in VAP patients due to suspected or documented Pseudomonas aeruginosa infection
- Trial name
- NCT02096328
- Testing
- POL7080
- Where
- 10 sites in Greece, Spain
- Volunteers
- 25 people
- Sponsor
- Polyphor Ltd.
Cystic Fibrosis
International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With 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) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF1 (NCT00112359)
- Testing
- AZLI 75 mg three times a day (TID)
- Where
- 53 sites in United States, Australia and 2 more
- Volunteers
- 166 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)
The purpose of this interventional Phase IV study was to explore the ease of use of TIP and prevalence of microbial contamination of the T-326 Inhaler compared with TIS and colistimethate administered via nebuliser for the…
- Trial name
- NCT01844778
- Testing
- Tobramycin Inhalation Powder, Tobramycin inhalation solution, Colistimethate
- Where
- 21 sites in Germany, Ireland and 3 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Infections, Pseudomonas
Phase I Study of Colistin Methanesulfonate Sodium
This is a clinical study protocol for a single centre, randomized, double blind, placebo controlled, single and repeat dose study to investigate the safety, tolerability and pharmacokinetics of intravenous dosing of Colistin…
- Trial name
- NCT01449838
- Testing
- Colistimethate sodium, Saline
- Where
- Australia
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Lymphoblastic Leukemia, Lymphoblastic Leukemia
An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation).
- Trial name
- NCT04145531
- Testing
- IM JZP-458, IV JZP-458
- Where
- 74 sites in United States, Canada
- Volunteers
- 229 people
- Sponsor
- Jazz Pharmaceuticals
Non-cystic Fibrosis Bronchiectasis
Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection
The purpose of this study was to support the selection of a safe and tolerable tobramycin inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P.
- Trial name
- iBEST-1 (NCT02712983)
- Testing
- TIP
- Where
- 34 sites in Belgium, France and 4 more
- Volunteers
- 107 people
- Sponsor
- Novartis Pharmaceuticals
Carbapenem-Resistant Enterobacteriaceae
Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Carba assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Carbapenemase…
- Trial name
- NCT03680898
- Testing
- Rectal swab collection
- Where
- 3 sites in United States, Canada
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Meridian Bioscience, Inc.
Cystic Fibrosis, Pseudomonas Aeruginosa Airway Infection
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P.
- Trial name
- NCT00499720
- Testing
- Aztreonam Lysine for Inhalation
- Where
- 65 sites in United States, Puerto Rico
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas Aeruginosa
A major factor in the respiratory health of Cystic Fibrosis (CF) subjects is the prevalence of chronic Pseudomonas aeruginosa infections.
- Trial name
- NCT01315691
- Testing
- Liposomal amikacin for inhalation
- Sponsor
- Insmed Incorporated
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
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
Non Cystic Fibrosis Bronchiectasis
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
This study (ARD-3150-1201, ORBIT-3) 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
- NCT01515007
- Testing
- Ciprofloxacin dispersion for inhalation
- Where
- 109 sites in United States, Australia and 14 more
- Volunteers
- 278 people
- Sponsor
- Aradigm Corporation
Cystic Fibrosis, Pseudomonas Aeruginosa
Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis
This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P.
- Trial name
- EAP (NCT00989807)
- Testing
- Aztreonam lysine
- Where
- 4 sites in Canada
- Sponsor
- Gilead Sciences
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
Pseudomonas Aeruginosa in Cystic Fibrosis
Observational Study in Cystic Fibrosis Patients Using TOBI® PODHALER® or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs
This is a multicenter, prospective, two cohort, observational study over a 5-year period in Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will collect data over 1 year on respiratory…
- Trial name
- NCT02449031
- Testing
- TOBI® PODHALER®, TOBI®, Bethkis®
- Where
- 47 sites in United States
- Volunteers
- 409 people
- Sponsor
- Mylan Inc.
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF2 (NCT00104520)
- Testing
- AZLI 75 mg two times a day (BID)/three times a day (TID)
- Where
- 56 sites in United States
- Volunteers
- 211 people
- Sponsor
- Gilead Sciences
Relapsed/Refractory Hairy Cell Leukemia
An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia
Early Access Programme to provide treatment access to moxetumomab pasudotox for eligible patients with relapsed/refractory hairy cell leukemia
- Trial name
- MOXE (NCT03501615)
- Testing
- Moxetumomab Pasudotox
- Sponsor
- AstraZeneca