Clinical trials: Lung Diseases, Fungal
Ventilator-associated Pneumonia, Hospital-acquired Pneumonia
Cefepime-taniborbactam vs Meropenem in Adults With VABP or Ventilated HABP
This is a Phase 3, randomized, multicenter, double-blind, non-inferiority study to evaluate the efficacy and safety of cefepime-taniborbactam compared to meropenem in patients ≥ 18 years of age with ventilated HABP or VABP.
- Trial name
- CERTAIN-2 (NCT06168734)
- Testing
- Cefepime-taniborbactam, Meropenem
- Sponsor
- Venatorx Pharmaceuticals, Inc.
Pneumococcal Infections, Pneumococcal Pneumonia
Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers
This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers.
- Trial name
- NCT01444001
- Testing
- Pneumococcal Vaccine
- Where
- Switzerland
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Sanofi
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF3 (NCT00128492)
- Testing
- AZLI 75 mg two times a day (BID)/ three times a day (TID)
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients
This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis patients following single and multiple doses.
- Trial name
- NCT02190604
- Testing
- QBW251
- Where
- 23 sites in United States, Belgium and 5 more
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Pneumonia, Bacterial
Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia
This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community acquired bacterial pneumonia (SCABP) requiring critical care measures
- Trial name
- NCT05776004
- Testing
- CAL02
- Where
- 90 sites in United States, Argentina and 17 more
- Volunteers
- 276 people
- Sponsor
- Eagle Pharmaceuticals, Inc.
Pneumococcal Disease
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
This is a Phase 3, randomized, double-blind study to evaluate the safety and immunogenicity of VAX-31 and seasonal influenza vaccine in pneumococcal-naïve adults ≥ 50 years when the two vaccines are administered at the same visit…
- Trial name
- NCT07365826
- Testing
- 31-valent pneumococcal conjugate vaccine, Seasonal Influenza Vaccine (SIV) (Flublok)
- Where
- 25 sites in United States
- Volunteers
- 1,390 people, healthy volunteers welcome
- Sponsor
- Vaxcyte, Inc.
Pneumonia, Pneumococcal, Vaccines, Pneumococcal
Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia
The main purpose of this study is to use an investigational urine assay to estimate the proportion of pneumonia in adults 50 years or older in different areas throughout the US that is caused by certain types of the bacteria…
- Trial name
- NCT01086397
- Testing
- Urine sample collection
- Where
- 14 sites in United States
- Volunteers
- 782 people
- Sponsor
- Pfizer
Asthma, Respiratory Candidiasis
The Effect of PC945 on Aspergillus or Candida Lung Infections in Patients With Asthma or Chronic Respiratory Diseases
This study tests the effects of an experimental drug PC945 in people with asthma or other chronic respiratory diseases whose lungs are infected by Aspergillus fungi and Candida yeasts.
- Conditions
- Asthma, Respiratory Candidiasis, Respiratory Aspergillosis, COPD
- Trial name
- NCT03745196
- Testing
- PC945
- Where
- 4 sites in United Kingdom
- Volunteers
- 13 people
- Sponsor
- Pulmocide Ltd
Pneumococcal Infections
A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)
This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune responses to the 13 serotypes in common…
- Trial name
- NCT01215188
- Testing
- V114 Aluminum-adjuvanted, V114 Non-adjuvanted, Prevnar 13®
- Volunteers
- 1,152 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Urinary Tract Infections, Bacterial Pneumonia
Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036)
This study will investigate the safety and efficacy of ertapenem versus ceftriaxone in pediatric patients with urinary tract infections, skin infections, or community-acquired pneumonia.
- Conditions
- Urinary Tract Infections, Bacterial Pneumonia, Soft Tissue Infections
- Trial name
- NCT00451386
- Testing
- MK0826, ertapenem sodium /Duration of Treatment: 14 Days, Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days
- Volunteers
- 400 people
- Sponsor
- Merck Sharp & Dohme LLC
Mycobacterium Avium Complex, Non-tuberculous Mycobacterium Pulmonary Disease
Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)
- Trial name
- NCT04553406
- Testing
- SPR720, Open-label Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 2 people
- Sponsor
- Spero Therapeutics
Fungal Infection
A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)
This single site study will examine plasma and alveolar compartment (AC) levels of posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant recipients receiving routine post-operative anti-fungal…
- Trial name
- PAPAL (NCT01667107)
- Testing
- Posaconazole, Calogen®
- Volunteers
- 26 people
- Sponsor
- Merck Sharp & Dohme LLC
Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in…
- Conditions
- Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE, Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE, Complicated Urinary Tract Infection (cUTI) Due to CRE
- Trial name
- CARE (NCT01970371)
- Testing
- plazomicin, colistin, meropenem
- Volunteers
- 69 people
- Sponsor
- Achaogen, Inc.
Cystic Fibrosis
Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)
- Trial name
- NCT00638365
- Testing
- KB001
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Humanigen, Inc.
Aspergillosis, Lung Transplant Infection
The Effect of Early Treatment of PC945 on Aspergillus Fumigatus Lung Infection in Lung Transplant Patients.
This study tests the effects of pre-emptive treatment with an experimental drug PC945 in lung transplant recipients whose lungs are infected by the fungus Aspergillus fumigatus.
- Trial name
- NCT03905447
- Testing
- PC945, Standard of Care
- Where
- 3 sites in United Kingdom
- Volunteers
- 2 people
- Sponsor
- Pulmocide Ltd
Cystic Fibrosis, Burkholderia Infection
A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection
The purpose of the study is to assess the efficacy of Alginate oligosaccharide (OligoG) dry powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection.
- Trial name
- SMR-2591 (NCT02453789)
- Testing
- Alginate oligosaccharide
- Where
- 2 sites in Germany
- Volunteers
- 15 people
- Sponsor
- AlgiPharma AS
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.
Vulvovaginal Candidiasis
Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis
This study evaluates the effect of a multi-strain probiotic on the risk of recurrence and severity of symptoms in females with recurrent vulvovaginal candidiasis (R-VVC).
- Trial name
- PROVELIA (NCT06480604)
- Testing
- Probiotic
- Where
- 6 sites in India
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- The Archer-Daniels-Midland Company
Acute Respiratory Distress Syndrome, Viral or Bacterial Infections
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
A Phase 2a, randomized, double-blind, placebo-controlled, multiple ascending dose study in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen therapy.
- Conditions
- Acute Respiratory Distress Syndrome, Viral or Bacterial Infections, Pneumonia, Pneumonia, Viral
- Trial name
- NCT05123755
- Testing
- AV-001 Injection
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Vasomune Therapeutics, Inc.
Urinary Tract Infection, Acute Pyelonephritis
Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults
This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types…
- Conditions
- Urinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia, Ventilator-associated Pneumonia
- Trial name
- NCT04882085
- Testing
- Zavicefta, Ceftazidime-Avibactam, Best Available Treatment
- Where
- 37 sites in China
- Volunteers
- 60 people
- Sponsor
- Pfizer