Clinical Trial Search

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

Primary: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization — 24; 26; 29; 21 number of participants — p=0.86

Primary: Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle — 84.6; 24.0 Percentage of participants — p=<0.001

Primary: Time to a Protocol-defined Pulmonary Exacerbation — 1.350; 0.758 years — p=0.0043

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 90; 180 participants

Primary: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab — 26.12; 25.82 Months

Primary: Time to an Exacerbation — 58; 51.5 Days — p=0.0715

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

Primary: Change in P. Aeruginosa Density — 0.23; -0.31; -0.31; -0.73 log10 CFU/g sputum — p=0.0014

Primary: Ceftolozane Clearance — 4.76 Liters per hour

Primary: Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) — 0.47; 1.67 Percent (%) change

Primary: Absolute Change in Forced Expiratory Volume at One Second (FEV1) % Predicted Between Study Arms With Acute Pulmonary Exacerbation (APE) Treatment — 6.5; 4.4; 4.5 ppFEV1

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

Primary: Blood-plasma Concentration of Piperacillin — 21; 21 mg/L

Primary: Percentage of Participants Who Discontinued Study Drug Due to Safety or Tolerability Reasons — 0.0 percentage of participants

Primary: Population Pharmacokinetics - Total Body Clearance — 0.36 L/hr/kg

Primary: Clinical Cure on Day 21 — 34; 37; 6; 5 Participants — p=0.6154

Primary: Relative Change in Lung Function — 1.69; -1.95 percent change — p=0.0846

Primary: Change in FEV1 — -0.07; -0.08 Liters

Primary: Chest CT (High Resolution Computed Tomography (HRCT) Score) — 3.7; 6.1 Score points

Primary: Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths — 85.4; 31.2; 0.0 Percentage of participants

Primary: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score — -2.63; 7.08 units on a scale — p=0.0005

Primary: Time to First Exacerbation Event Within 48 Weeks — 336; NA; 186 Days — p=0.0650

Primary: Percent Reduction in Oxygen Requirement From Baseline — 5.4; 16.5 percentage FiO2

Primary: Number of Participants Reporting Adverse Events (AEs) — 83; 185; 30; 79 participants

Primary: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics — 71; 92 Days — p=0.0070

Primary: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture — 2; 3 Participants

Primary: Clinically Significant Laboratory Abnormalities. — 1; 0; 8; 7 Participants

Primary: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). — -2.94; -0.32 log10 of CFU per gram sputum — p=< 0.001

Primary: Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. — 48; 15; 28; 15 participants