N/A N=12 Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF
Cystic Fibrosis
Primary: The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation. — 0; 0 adverse events
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=158 Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Pseudomonas Aeruginosa Pneumonia
Primary: Clinical Cure on Day 21 — 34; 37; 6; 5 Participants — p=0.6154
Phase 3 N=123 Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis
Cystic Fibrosis
Primary: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab — 26.12; 25.82 Months
Phase 3 N=282 Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients
Cystic Fibrosis
Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 90; 180 participants
Phase 2 N=105 Aztreonam Lysine for Pseudomonas Infection Eradication Study
Cystic Fibrosis
Primary: Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set) — 58.2 percentage of participants
Phase 2 N=304 Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis
Cystic Fibrosis · Pulmonary Disease, Chronic Obstructive
Primary: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization — 24; 26; 29; 21 number of participants — p=0.86
Phase 3 N=294 Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
Pseudomonas Aeruginosa Infection
Primary: Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) — 0.47; 1.67 Percent (%) change
Phase 3 N=330 MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
Cystic Fibrosis
Primary: Time to an Exacerbation — 58; 51.5 Days — p=0.0715
Phase 2 N=188 Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Pseudomonas Aeruginosa
Primary: Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa — 18.1; 12.5; 22.4 Percentage of participants — p=0.491
Phase 2 N=48 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
Non-cystic Fibrosis Bronchiectasis · Pseudomonas Aeruginosa · Lung Infection
Primary: P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation — -0.5; -0.1; -0.4; 1.0 colony forming units log10
Phase 2 N=151 Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
Cystic Fibrosis (CF)
Primary: Change in P. Aeruginosa Density — 0.23; -0.31; -0.31; -0.73 log10 CFU/g sputum — p=0.0014
Phase 3 N=221 OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis
Cystic Fibrosis
Primary: Time to a Protocol-defined Pulmonary Exacerbation — 1.350; 0.758 years — p=0.0043
Phase 2 N=27 Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
Cystic Fibrosis
Primary: The Safety and Tolerability of a Single-dose of KB001. — 7; 10; 8 Number of participants experiencing AEs
Phase 3 N=273 Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa
Cystic Fibrosis
Primary: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 — 8.35; 0.55 percent change in FEV1 percent predicted — p=0.0001
Phase 2 N=66 Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)
Cystic Fibrosis
Primary: Clinically Significant Laboratory Abnormalities. — 1; 0; 8; 7 Participants
Phase 2 N=64 Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.
Bronchiectasis
Primary: Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment — 2; 3; 2; 3 Participants
Phase 3 N=725 Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
Pneumonia, Bacterial
Primary: Number of Participants Surviving Through LFU Visit — 191; 196; 64; 57 Participants — p=0.4263
Phase 2 N=29 Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
Cystic Fibrosis · Pseudomonas Aeruginosa · Pseudomonas
Primary: Incidence and Severity Treatment Emergent Adverse Events (TEAEs) — 1; 1; 1; 0 Participants
Phase 3 N=164 International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
Cystic Fibrosis
Primary: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score — -2.63; 7.08 units on a scale — p=0.0005
N/A N=10 Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis
Cystic Fibrosis
Primary: Blood-plasma Concentration of Piperacillin — 21; 21 mg/L
Phase 2 N=29 Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)
Cystic Fibrosis
Primary: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture — 2; 3 Participants
Phase 2 N=49 Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase
Cystic Fibrosis
Primary: Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. — 48; 15; 28; 15 participants
Phase 3 N=211 Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
Cystic Fibrosis
Primary: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics — 71; 92 Days — p=0.0070
Phase 4 N=21 Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients
Cystic Fibrosis · Cystic Fibrosis Pulmonary Exacerbation · Pseudomonas Aeruginosa Infection
Primary: Ceftolozane Clearance — 4.76 Liters per hour
Phase 4 N=982 Standardized Treatment of Pulmonary Exacerbations II
Pulmonary Cystic Fibrosis
Primary: Absolute Change in FEV1 % Predicted From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day — 13.30; 13.83 percentage change — p=0.0164
N/A N=22 Piperacillin PK Analysis in Severe Sepsis Patients
Sepsis · Severe Sepsis
Primary: 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. — 4 participants
Phase 3 N=274 Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
Cystic Fibrosis
Primary: Number of Participants Reporting Adverse Events (AEs) — 83; 185; 30; 79 participants
Phase 4 N=146 Preventing Staphylococcal (Staph) Infection
Staphylococcal Infections
Primary: Re-infection With S. Aureus — 10; 11; 0; 0 participants with S. aureus re-infection — p=0.356
Phase 3 N=188 AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis
MRSA · Cystic Fibrosis
Primary: Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted — 2.39; 1.18; 1.52; 0.13 Percent predicted — p=0.325
Phase 3 N=51 Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Primary: Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle — 84.6; 24.0 Percentage of participants — p=<0.001