Clinical Trials Logo
  1. Home
  2. Community-Acquired Pneumonia
  3. NCT00417326
  4. Details
NCT00417326 Clinical Trial

Controlled Study of ONO-5046Na in Patients With Acute Respiratory Failure Associated With Community-Acquired Pneumonia

Community-acquired Pneumonia Clinical Trial

Official title:
ONO-5046Na Phase II Study - A Pilot Study for Patients With Acute Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00417326
Other study ID # ONO-5046Na-14
Secondary ID
Status Completed
Phase Phase 2
First received December 28, 2006
Last updated June 12, 2012
Start date December 2006

Study information
Verified date June 2012
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of ONO-5046Na in patients with acute respiratory failure associated with community-acquired pneumonia

Recruitment information / eligibility
Status Completed
Enrollment 174
Est. completion date
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility Inclusion Criteria:

- Patients with community-acquired pneumonia

- Patients with acute respiratory failure

Exclusion Criteria:

- Patients with nosocomial pneumonia

- Patients on mechanical ventilation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-5046Na
twenty four hour infusion at 0 mg/kg/hr for 14 days
• ONO-5046Na
twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days

Locations
Country Name City State
Japan Chubu Region Chubu
Japan Chugoku Region Chugoku
Japan Hokkaido Region Hokkaido
Japan Hokuriku Region Hokuriku
Japan Kanto Region Kanto
Japan Kinki Region Kinki
Japan Kyushu Region Kyushu
Japan Shikoku Region Shikoku
Japan Tohoku Region Tohuku

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary pulmonary function 14 days No
Secondary mortality 28 days No
Secondary ventilator status 28 days No
See also
  Status Clinical Trial Phase
Recruiting NCT05722938 - Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) Phase 3
Terminated NCT04972318 - Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia N/A
Recruiting NCT06065618 - Characteristics of Hospitalized Patients With Community-acquired Pneumonia
Not yet recruiting NCT03675178 - Clinical Study of Anerning Particle for the Treatment of Childhood Community-acquired Pneumonia Phase 4
Not yet recruiting NCT04166110 - Antibiotic Therapy In Respiratory Tract Infections N/A
Completed NCT02380352 - Short-course Antimicrobial Therapy for Paediatric Respiratory Infections Phase 4
Completed NCT01671280 - Drug Use Investigation Of Azithromycin IV For Community-Acquired Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan) N/A
Completed NCT02555852 - Proton Pump Inhibitors and Risk of Community-acquired Pneumonia N/A
Recruiting NCT00752947 - Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors Phase 4
Completed NCT00140023 - Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia Phase 3
Recruiting NCT04089787 - Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia Phase 4
Completed NCT05356494 - Postural Drainage and PEP Technique in Community Acquired Pneumonia N/A
Completed NCT05133752 - Oral Nemonoxacin in Treating Elderly Patients With CAP Phase 4
Not yet recruiting NCT06291012 - Stopping Pneumonia Antibiotherapy Regimen Early Phase 4
Recruiting NCT05002192 - A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
Completed NCT03452826 - Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia N/A
Terminated NCT04071041 - Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia. Phase 3
Completed NCT03474991 - KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP Phase 3
Withdrawn NCT01662258 - Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP N/A
Completed NCT01683487 - Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Phase 4