Community Acquired Pneumonia Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Randomized, Dose-Escalating Study of Single (Part A) and Multiple (Part B) Intravenous Doses of Friulimicin B in Healthy Subjects
Verified date | July 2008 |
Source | MerLion Pharmaceuticals GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
The purpose of this study is to study the safety of single doses and multiple doses of Friulimicin B in healthy volunteers. The level of Friulimicin B will be measured in the subjects blood and urine. One part of the study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.
Status | Terminated |
Enrollment | 31 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Male or female healthy subjects - 18-55 years of age - In good health Exclusion Criteria: - Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Swiss Pharma Contract Ltd | Basel |
Lead Sponsor | Collaborator |
---|---|
MerLion Pharmaceuticals GmbH |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the safety and tolerability of single and multiple intravenous doses of Friulimicin B by assessing adverse events, physical examinations,clinical chemistry examination, hematology, ECG and urinalysis. | 5 days | ||
Secondary | To determine the pharmacokinetic profile of single and multiple intravenous doses of Friulimicin B in healthy subjects | 5 days | ||
Secondary | To determine the bactericidal activity of serum obtained from healthy subjects after administration of Friulimicin B | 5 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02559310 -
Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia
|
Phase 3 | |
Completed |
NCT01530763 -
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)
|
Phase 2/Phase 3 | |
Completed |
NCT02517489 -
Community-Acquired Pneumonia : Evaluation of Corticosteroids
|
Phase 3 | |
Not yet recruiting |
NCT01937832 -
A Phase III Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
|
Phase 3 | |
Completed |
NCT02454114 -
HOME FIRST Pilot: a Study of Early Supported Discharge in Patients With Lower Respiratory Tract Infections
|
N/A | |
Completed |
NCT00653172 -
Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia
|
Phase 2 | |
Recruiting |
NCT02139163 -
Epidemiological Study on Community Acquired Pneumonia
|
||
Completed |
NCT03411824 -
Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine
|
||
Recruiting |
NCT06210282 -
The Effect of Focused Lung Ultrasonography on Antibiotic Prescribing in General Practice
|
N/A | |
Withdrawn |
NCT02269644 -
A P3 Comparator Trial in Community Acquired Bacterial Pneumonia
|
Phase 3 | |
Recruiting |
NCT01963442 -
Short Duration Treatment of Non-severe Community Acquired Pneumonia
|
Phase 2 | |
Terminated |
NCT00887276 -
Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia
|
Phase 4 | |
Not yet recruiting |
NCT00390819 -
Epidemiology of Community Acquired Pneumonia in North Israel
|
N/A | |
Completed |
NCT00079885 -
Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia
|
Phase 3 | |
Not yet recruiting |
NCT04158310 -
Evaluation the Clinical Value of Xiyanping Injection in the Treatment of Community-acquired Pneumonia in Children
|
||
Recruiting |
NCT02552342 -
Corticosteroid Therapy for Severe Community-Acquired Pneumonia
|
Phase 4 | |
Completed |
NCT02922387 -
Smoking Cessation Intervention in Respiratory Inpatients
|
Phase 4 | |
Completed |
NCT00467701 -
Community Acquired Pneumonia in Telemark and Ostfold
|
N/A | |
Completed |
NCT04198571 -
Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries
|
||
Completed |
NCT02107001 -
Lung Ultrasound in Pleuritic Chest Pain
|
N/A |