Phase 2 N=154 Ciprofloxacin BioThrax Co-Administration Study
Anthrax
Primary: Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44) — 0.944; 0.887 ratio
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=200 Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
Anthrax
Primary: Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). — 71.2; 68.5; 73.9; 76.7…
Phase 3 N=20 An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection
Therapeutic Treatment of Inhalation Anthrax
Primary: Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response — 0 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=129 Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
Anthrax
Primary: Number of Participants Reporting Adverse Events (AEs) — 28; 5; 29; 11 Participants
Phase 2 N=25 Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19
Covid19 · Pneumonia, Viral
Primary: Count of White Blood Cells (WBC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With…
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
N/A N=25 Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections
Fasciitis, Necrotizing · Severe Necrotizing Skin and Soft Tissue Infections · Fournier's Gangrene
Primary: Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT) — 16; 0; 2; 0 Participants
Phase 4 N=573 Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed
Infections, Bacterial
Primary: Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose)…
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 2 N=210 Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
Anthrax
Primary: Ratio of Ciprofloxacin Area Under the Curve From 0 to 12 Hours (AUC0-12h) and Maximum Concentration (Cmax) on Days 8 and 35 — 0.9764; 0.9706 Ratio
Phase 4 N=1,564 Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change
Healthy
Primary: Local AEs — 500; 344; 186; 189 injections
Phase 2 N=89 Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria
Mycobacterium Infections, Nontuberculous
Primary: Change in Semi-Quantitative Mycobacterial Culture Results From Baseline to Day 84. — 5; 5; 1; 1 Participants — p=0.072
Phase 3 N=32 Aztreonam for Pharyngeal Gonorrhea
Gonorrhea of Pharynx · Gonorrhea
Primary: Treatment Efficacy of Pharyngeal Gonorrhea as Defined as the Proportion of Study Participants With Positive Pharyngeal Gonorrhea Culture at of Enrollment Whose Test of…
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
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=305 BARDA Securing Anthrax Immunity For the Elderly
Anthrax
Primary: Solicited Local Reactogenicity Symptoms — 46; 43; 40; 45 Participants
Phase 3 N=48 Voriconazole For Chronic Bronchopulmonary Aspergillosis
Aspergillosis
Primary: Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis — 13; 28 participants
Phase 2 N=36 Targeted Therapy of Bronchiolitis Obliterans Syndrome
Bronchiolitis Obliterans
Primary: Number of Subjects Who Failed Treatment — 2 Participants
Phase 3 N=266 Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
Bronchiectasis
Primary: Change in QOL-B Respiratory Symptoms Score at Day 28 — 7.4; 5.7 units on a scale — p=0.68
Phase 3 N=274 Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
Bronchiectasis
Primary: Change in QOL-B Respiratory Symptoms Score at Day 28 — 8.2; 3.2 units on a scale — p=0.011
Phase 2 N=143 Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia
Pneumonia, Bacterial
Primary: Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to…
N/A N=102 Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H Pylori Infection
Helicobacter Pylori Infection
Primary: Number of Participants in Which H. Pylori Was Eradicated — 36; 49 participants — p=<0.001
Phase 1 N=41 Anthrax AV7909 Liquid vs Lyophilized
Anthrax · Anthrax Immunisation
Primary: Number of Participants With Serious Adverse Events (SAEs). — 0; 0 Participants
Phase 2 N=5 A Clinical Trial to Evaluate the Safety and Efficacy of Ciprofloxacin in the Treatment of Plague in Humans
Plague
Primary: Number of Participants Achieving Clinical Cure — 5 Participants
Phase 4 N=83 Azithromycin in Bronchiolitis Obliterans Syndrome
Bronchiolitis Obliterans Syndrome · Graft Rejection · Lymphocytic Bronchiolitis
Primary: Prevalence of Bronchiolitis Obliterans Syndrome (BOS) — 5; 19 participants
Phase 1 N=105 Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
Bacillus Anthracis (Anthrax) Infection
Primary: Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) — 11; 17; 13…
Phase 4 N=328 Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule
Bacillus Anthracis (Anthrax)
Primary: Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody…
Phase 3 N=144 Targeted Retreatment of COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
Primary: Time to the Next COPD Exacerbation — 72; 58 days — p=0.764
Phase 2 N=69 Essentiality of INH in TB Therapy
Tuberculosis
Primary: Daily Decrease in log10 Transformed Colony-forming Unit (CFU) Counts Per ml Sputum From Baseline (Study Treatment Initiation) to Day 14 — 0.134; 0.096; 0.136; 0.119…