Clinical trials: Respiratory Tract Infection Bacterial
Pulmonary TB
A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis
This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis (TB).
- Trial name
- NCT03678688
- Testing
- 10 mg OPC-167832, 30 mg OPC-167832, 90 mg OPC-167832
- Where
- 3 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pneumococcal Infections, COPD
Immunization To Prevent Acute COPD Exacerbations
Prospective multicenter observational study, to evaluate the impact of routine clinical practice vaccination with PCV13 on the reduction of the risk of moderate/severe COPD exacerbations
- Trial name
- NCT03276754
- Where
- 11 sites in Spain
- Volunteers
- 530 people
- Sponsor
- Pfizer
Diphtheria, Tetanus
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
Primary Objectives: 1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2.
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT00258895
- Testing
- DAPTACEL®: DTaP
- Where
- 22 sites in United States
- Volunteers
- 649 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pneumonia, Bacterial, Community-acquired
Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia
This study will further analyze the use of ceftaroline for CABP and compare its potential to eradicate bacterial pathogens to standard fluoroquinolone therapy.
- Trial name
- NCT01524302
- Testing
- Ceftaroline, Levofloxacin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Gary E. Stein, Pharm.D.
Acellular Pertussis, Tetanus
US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention…
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00282295
- Testing
- Boostrix®, Menactra™
- Where
- 24 sites in United States
- Volunteers
- 1,344 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Primary Objective: To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00831311
- Testing
- DTaP-IPV-HB-PRP~T, DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
- Where
- Argentina
- Volunteers
- 624 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pulmonary Tuberculosis
Assessing PA-824 for Tuberculosis (the APT Trial)
Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic) over 12 weeks of treatment.
- Trial name
- NCT02256696
- Testing
- PA-824, Rifampin, Rifabutin
- Where
- South Africa
- Volunteers
- 157 people
- Sponsor
- Johns Hopkins University
Lung Diseases, Obstructive, Sarcoidosis
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
The purpose of this study is to evaluate the safety, effectiveness, and side effects of the CryoSpray AblationTM System (CryoSpray AblationTM, "CSA" or "cryospray therapy") to treat benign airway disease in the lung using liquid…
- Conditions
- Lung Diseases, Obstructive, Sarcoidosis, Wegener's Granulomatosis, Rhinoscleroma
- Trial name
- ICEtheBAD (NCT00747461)
- Testing
- CryoSpray Ablation
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- CSA Medical, Inc.
Tuberculosis
An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis
Tuberculosis remains a concerning health problem, with Mycobacterium Tuberculosis (MTB) now causing more deaths than acquired immune deficiency syndrome (AIDS).
- Trial name
- NCT03557281
- Testing
- GSK3036656, Rifafour e-275
- Where
- South Africa
- Volunteers
- 76 people
- Sponsor
- GlaxoSmithKline
Community Acquired Pneumonia
Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Pneumonia and Pneumococcal Vaccine
The aim of this study is to test if BPS (Bacterial Pneumonia Score) guided antibiotic use in children with non severe community acquired pneumonia (CAP) and pneumoccocal vaccine will reduce antibiotic use as compared to standard…
- Trial name
- NCT01875731
- Testing
- BPS, Guideline
- Where
- Argentina
- Volunteers
- 66 people
- Sponsor
- Hospital General de Niños Pedro de Elizalde
Infections, Streptococcal
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either…
- Trial name
- NCT00370396
- Testing
- Synflorix, Prevenar, Infanrix hexa
- Where
- 35 sites in Finland, France and 1 more
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis, Pulmonary
Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design
This study is a multiple-arm, multiple-stage (MAMS), phase 2, open label, randomized, controlled clinical trial that will compare the efficacy and safety of four experimental four drug regimens with a standard control regimen in…
- Trial name
- NCT01785186
- Testing
- SQ109, Rifampicin, Moxifloxacin
- Where
- 7 sites in South Africa, Tanzania
- Volunteers
- 365 people
- Sponsor
- Michael Hoelscher
Pertussis, Tetanus
Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
- Conditions
- Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00319553
- Testing
- ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed, BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
- Where
- 10 sites in United States
- Volunteers
- 647 people, healthy volunteers welcome
- Sponsor
- Sanofi
Cystic Fibrosis, Pseudomonas Aeruginosa
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered…
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection
- Trial name
- SWARM-Pa (NCT04596319)
- Testing
- AP-PA02
- Where
- 20 sites in United States
- Volunteers
- 29 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Pulmonary Tuberculosis
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive…
- Trial name
- NCT00567840
- Testing
- PA-824
- Where
- 2 sites in South Africa
- Volunteers
- 69 people
- Sponsor
- Global Alliance for TB Drug Development
Community Acquired Pneumonia
Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia
This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate community-acquired bacterial pneumonia
- Trial name
- LEAP2 (NCT02813694)
- Testing
- lefamulin, Moxifloxacin
- Where
- 155 sites in United States, Argentina and 18 more
- Volunteers
- 738 people
- Sponsor
- Nabriva Therapeutics AG
Refractory IPA
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
- Trial name
- NCT05238116
- Testing
- PC945
- Where
- 83 sites in United States, Argentina and 18 more
- Volunteers
- 85 people
- Sponsor
- Pulmocide Ltd
Pertussis, Tetanus
A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older
It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP…
- Conditions
- Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00457249
- Testing
- ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed, DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
- Where
- 19 sites in United States
- Volunteers
- 1,564 people, healthy volunteers welcome
- Sponsor
- Sanofi
Nosocomial Pneumonia (NP), Ventilator-associated Pneumonia (VAP)
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia
- Trial name
- NCT01808092
- Testing
- ceftazidim-avibactam (CAZ-AVI, experimental product), meropenem (active comparator)
- Where
- 123 sites in Argentina, Brazil and 24 more
- Volunteers
- 969 people
- Sponsor
- Pfizer
Diphtheria, Tetanus
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00313911
- Testing
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- Where
- 2 sites in Mexico, Peru
- Volunteers
- 2,133 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company