Clinical trials: Pseudomonas Infection
Cystic Fibrosis
A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)
The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary function as measured by a 5% or greater relative improvement in forced expiratory volume in one second (FEV1) from baseline to Day 28.
- Trial name
- NCT02354859
- Testing
- Gallium nitrate, Normal Saline
- Where
- 23 sites in United States
- Volunteers
- 119 people
- Sponsor
- University of Washington
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
Hairy Cell Leukemia
LMB-2 to Treat Hairy Cell Leukemia
Background: About 80% of patients with hairy cell leukemia (HCL) have tumor cells that have a protein on their surface called cluster of differentiation 25 (CD25).
- Trial name
- NCT00321555
- Testing
- Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Cancer Institute (NCI)
Cystic Fibrosis, Pseudomonas Aeruginosa
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation…
- Trial name
- PALS (NCT01404234)
- Testing
- AZLI
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Bacterial Disease Carrier, Cystic Fibrosis
A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa
This is a phase 1b/2 study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF).
- Trial name
- NCT05453578
- Testing
- WRAIR-PAM-CF1
- Where
- 19 sites in United States
- Volunteers
- 73 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive
Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis
Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main…
- Trial name
- EPIC (NCT00097773)
- Testing
- Tobramycin solution for inhalation (TOBI), Oral ciprofloxacin
- Where
- 54 sites in United States
- Volunteers
- 304 people
- Sponsor
- Seattle Children's Hospital
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
CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)
This is a Phase 2 study with primary objective of looking whether YPT-01 phage therapy reduces sputum bacterial load in cystic fibrosis subjects with Pseudomonas aeruginosa.
- Trial name
- NCT04684641
- Testing
- Standard Dose YPT-01
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Yale University
Cystic Fibrosis
Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis
This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution.
- Trial name
- ELITE (NCT00391976)
- Testing
- Tobramycin solution for inhalation 300 mg
- Volunteers
- 123 people
- Sponsor
- Novartis
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
Pseudomonas Aeruginosa Infection
Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections.
- Trial name
- NCT01315678
- Testing
- Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
- Where
- 62 sites in Austria, Belgium and 16 more
- Volunteers
- 302 people
- Sponsor
- Insmed Incorporated
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
Pseudomonas Aeruginosa
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.
- Trial name
- EVADE (NCT02696902)
- Testing
- MEDI3902
- Where
- 78 sites in United States, Austria and 12 more
- Volunteers
- 188 people
- Sponsor
- MedImmune LLC
Cystic Fibrosis
Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa.
- Trial name
- NCT01316276
- Testing
- Liposomal amikacin for inhalation
- Where
- 50 sites in Austria, Belgium and 15 more
- Volunteers
- 206 people
- Sponsor
- Insmed Incorporated
Bacterial Pneumonia
Clinical Trials to Reduce the Risk of Antimicrobial Resistance
The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical…
- Trial name
- NCT01570192
- Testing
- IV meropenem, I.V. Meropenem, Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 43 people
- Sponsor
- University of Florida
Pseudomonas Aeruginosa Pneumonia
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.
- Trial name
- NCT03027609
- Testing
- AR-105
- Where
- 111 sites in United States, Australia and 15 more
- Volunteers
- 158 people
- Sponsor
- Aridis Pharmaceuticals, Inc.
Tracheostomy Infection
The Use of Inhaled Aztreonam in Children With a Tracheostomy Tube and Pseudomonas
This is a prospective, case-control clinical trial using inhaled Aztreonam (AZLI) in pediatric patients with a tracheostomy tube colonized with Pseudomonas aeruginosa.
- Trial name
- A-PACT (NCT03158116)
- Testing
- Inhaled Aztreonam
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- UCSF Benioff Children's Hospital Oakland
Bronchiectasis
Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.
This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas…
- Trial name
- NCT00775138
- Testing
- 280 mg Arikayce™, 560 mg Arikayce™
- Where
- 18 sites in United States, Bulgaria and 7 more
- Volunteers
- 64 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis, Pneumonia
Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
This study will determine the concentrations of the antibiotic meropenem when administered as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an acute pulmonary exacerbation.
- Conditions
- Cystic Fibrosis, Pneumonia, Pseudomonas Aeruginosa Infection
- Trial name
- NCT01429259
- Testing
- meropenem
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- Joseph Kuti