Pneumonia Clinical Trial
Official title:
A Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Placebo in the Treatment of Subjects Hospitalized With Community-Acquired Pneumonia
Verified date | July 2012 |
Source | Basilea Pharmaceutica |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to compare the clinical cure rate (ratio of clinically cured patients to the total number of patients) of ceftobiprole medocaril versus a comparator in the treatment of patients with community-acquired pneumonia.
Status | Completed |
Enrollment | 638 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients suffering from community-acquired pneumonia severe enough to require hospitalization - Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study Exclusion Criteria: - Patients with known or suspected hypersensitivity to any related antibiotic medications - Treatment with any experimental drug within 30 days before enrollment - Prior enrollment in this study or any study with ceftobiprole medocaril |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Basilea Pharmaceutica |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical cure rate (ratio of the number of clinically cured patients to the total number of patients) at the test of cure visit that occurs 7 to 14 days after the last dose of study drug | 7 weeks | No | |
Secondary | Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients) | 7 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04244474 -
Effect of Vitamin D Supplementation on Improvement of Pneumonic Children
|
Phase 1/Phase 2 | |
Completed |
NCT05815264 -
Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above
|
Phase 1 | |
Recruiting |
NCT04589936 -
Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care
|
N/A | |
Completed |
NCT02905383 -
The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital
|
N/A | |
Completed |
NCT06210737 -
A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months,7 Months-5 Years
|
Phase 4 | |
Terminated |
NCT03944551 -
Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa
|
N/A | |
Terminated |
NCT04660084 -
Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Withdrawn |
NCT05702788 -
Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)
|
Phase 2 | |
Not yet recruiting |
NCT04171674 -
Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.
|
N/A | |
Active, not recruiting |
NCT03140163 -
Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]
|
N/A | |
Completed |
NCT02864420 -
Hospitalization at Home: The Acute Care Home Hospital Program for Adults
|
N/A | |
Completed |
NCT02638649 -
Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
|
||
Recruiting |
NCT02515565 -
Physiotherapy in Patients Hospitalized Due to Pneumonia.
|
N/A | |
Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
Completed |
NCT01446926 -
Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants
|
Phase 1 | |
Completed |
NCT01416519 -
Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation
|
N/A | |
Completed |
NCT01399723 -
Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia
|
Phase 3 | |
Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
Completed |
NCT01416506 -
Community-Acquired Pneumonia (CAP) Surveillance
|
N/A |