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Efficacy and Safety of Colistimethate Sodium Injection Vial to Treat Hospital-acquired Pneumonia in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01940731
Recruitment Status : Unknown
Verified September 2013 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : September 12, 2013
Last Update Posted : September 12, 2013
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
  1. To evaluate the clinical and microbiological efficacy and safety of Colistimethate sodium Injection Vial to treat adults with hospital-acquired pneumonia .
  2. To Learn the pharmacokinetic characteristics of continuous intravenous infusion of Colistimethate sodium.

Condition or disease Intervention/treatment Phase
Hospital-acquired Pneumonia Drug: Colistimethate sodium Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open, Non-controlled, Multi-center Study of Efficacy and Safety of Colistimethate Sodium Injection Vial to Treat Hospital-acquired Pneumonia in Adults.
Study Start Date : October 2013
Estimated Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Colistimethate sodium Drug: Colistimethate sodium
3-5mg/(kg.d)(if CLcr≥80 mL/min),The maximum dose≤300mg/d 2.5-3.8mg/(kg.d)(if CLcr=50-79mL/min),The maximum dose≤230mg/d twice a day

Primary Outcome Measures :
  1. Per subject clinical cure rate [ Time Frame: 14-28 days ]
  2. Per subject microbiological cure rate [ Time Frame: 14-28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Aged between 18-75, either male or female
  2. Women of childbearing age having negative pregnancy test at the time of enrollment and agreeing to take effective contraceptive measures from the delivery to 7 ~14 days after stopping .
  3. Defined as hospital-acquired pneumonia with following criteria
  4. fever, axillary temperature ≥37.3℃, oral temperature≥37.8℃, tympanic temperature≥38.2℃, rectal temperature≥38.4℃ or hypothermia rectal temperature<35℃
  5. WBC>10000/μL or <4000μL, neutrophils>70%, rod neutrophils>10%
  6. Pathogens are or highly suspected to be aerobic gram-negative bacilli.
  7. Before 72h of admin agents, drug treatment which used for Systemic antibacterial activity against gram-negative bacteria,is less than 48 hours. If it was more than 48h, there must be evidence for clinic failure, eg. continue fever.WBC and neutrophils irregular, or respiratory secretions/blood bacterial culture are positive.
  8. Informed consent granted.

Exclusion Criteria:

  1. Pneumonia infected within 48h admission.
  2. Before 72h of admin agents, drug treatment for Systemic antibacterial activity is more than 48 hours, unless clinical treatment failure .
  3. Patients known or suspected by the single infection of aerobic Gram-positive cocci.
  4. Patients known to have single or mixed infections by Stenotrophomonas narrow food Aeromonas or Burkholderia.
  5. Patients with impaired consciousness.
  6. Patients with primary pulmonary fibrosis, cystic fibrosis, lung cinerea pneumonia, active tuberculosis, Bronchial obstruction, history of obstructive pneumonia (mild to severe COPD were admission), primary lung cancer, other tumor metastasis to the lungs, bronchiectasis, lung abscess, empyema, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophil infiltration, pulmonary vasculitis, pleural effusion as the primary foci, aspiration pneumonia, fungal pneumonia and atypical pathogens pneumonia.
  7. Patients have other bacterial infection lesions and require other antimicrobial drug therapy that may hinder the efficacy of the study drug evaluation.
  8. Glucocorticoids(eg ,prednisone 20mg/d, treatment≥2 week) and immunosuppressant were used,or known HIV positive and immunocompromised.
  9. Patients have immediate evidence of life-threatening diseases, including, but not limited to, acute congestive heart failure, acute coronary syndrome, or unstable arrhythmia.
  10. Patients with sustainable shock after making adequate fluid resuscitation (systolic blood pressure >90mmHg) for more than 2h and having evidence of hypoperfusion or need sympathomimetic drugs to keep steady blood pressure.
  11. Patients with severe neutropenia syndrome (neutrophils<500 cells/mm3) or expected to suffer severe reduction in neutrophil within 14days, or had taken G-GSF before 48h of study.
  12. Any patients with end-stage disease.
  13. Patients have medical record with multiple polymyxin anaphylactoid reactions.( urticaria, angioedema, anaphylaxis, rash, scaling, etc.)
  14. Patients have Child Pugh C chronic liver disease, or liver function is abnormal.( AST or AST/ALT were greater than 5 times the upper limit of normal, total bilirubin greater than 2 times the upper limit of normal)
  15. Patients in need of major surgery
  16. Patients with moderate or severe renal impairment (CrCL>50ml/min)
  17. Patients have taken part in clinical trials of Colistimethate sodium。
  18. Patients have taken part in other drug and instrument clinical trials.
  19. Pregnant , breastfeeding and keep breastfeeding
  20. Patients involving in planning or operation of study
  21. Patients have poor compliance with study-specific procedures and related restrictions.
  22. disease which may be harmful to patients or quality of data
  23. History of epilepsy or myasthenia gravis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01940731

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Contact: Wu Ju Fang 13816357099

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West China Hospital ,Sichuan University Not yet recruiting
Chengdu, China, 610041
The Seond Hospital of Jilin University
Jilin, China, 13004
Huashan Hospital ,Fudan University Not yet recruiting
Shanghai, China, 200040
Shanghai Tenth people's Hospital Not yet recruiting
Shanghai, China, 200072
Shanghai Pulmonary Hospital Not yet recruiting
Shanghai, China, 200433
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Identifier: NCT01940731     History of Changes
Other Study ID Numbers: CCTQ01458-2-CTF
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
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Healthcare-Associated Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents