Hospital-acquired PneumoniaPhase 2NCT01940731
Efficacy and Safety of Colistimethate Sodium Injection Vial to Treat Hospital-acquired Pneumonia in Adults
A Phase 2 study testing Colistimethate sodium in people with Hospital-acquired Pneumonia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hospital-acquired Pneumonia
- What is being tested?
- Colistimethate sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesChina
- Study dates
- Oct 2013to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-75, either male or female
- 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 .
- Defined as hospital-acquired pneumonia with following criteria
- fever, axillary temperature ≥37.3℃, oral temperature≥37.8℃, tympanic temperature≥38.2℃, rectal temperature≥38.4℃ or hypothermia rectal temperature<35℃
- WBC>10000/μL or <4000μL, neutrophils>70%, rod neutrophils>10%
- Pathogens are or highly suspected to be aerobic gram-negative bacilli.
- 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.
- Informed consent granted.
Who cannot join
- Pneumonia infected within 48h admission.
- Before 72h of admin agents, drug treatment for Systemic antibacterial activity is more than 48 hours, unless clinical treatment failure .
- Patients known or suspected by the single infection of aerobic Gram-positive cocci.
- Patients known to have single or mixed infections by Stenotrophomonas narrow food Aeromonas or Burkholderia.
- Patients with impaired consciousness.
- 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.
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- Patients have other bacterial infection lesions and require other antimicrobial drug therapy that may hinder the efficacy of the study drug evaluation.
- Glucocorticoids（eg ,prednisone 20mg/d, treatment≥2 week） and immunosuppressant were used，or known HIV positive and immunocompromised.
- Patients have immediate evidence of life-threatening diseases, including, but not limited to, acute congestive heart failure, acute coronary syndrome, or unstable arrhythmia.
- 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.
- 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.
- Any patients with end-stage disease.
- Patients have medical record with multiple polymyxin anaphylactoid reactions.( urticaria, angioedema, anaphylaxis, rash, scaling, etc.)
- 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)
- Patients in need of major surgery
- Patients with moderate or severe renal impairment (CrCL>50ml/min)
- Patients have taken part in clinical trials of Colistimethate sodium。
- Patients have taken part in other drug and instrument clinical trials.
- Pregnant , breastfeeding and keep breastfeeding
- Patients involving in planning or operation of study
- Patients have poor compliance with study-specific procedures and related restrictions.
- disease which may be harmful to patients or quality of data
- History of epilepsy or myasthenia gravis.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
West China Hospital ,Sichuan University
Chengdu, 610041
The Seond Hospital of Jilin University
Jilin City, 13004
Huashan Hospital ,Fudan University
Shanghai, 200040
Shanghai Tenth people's Hospital
Shanghai, 200072
Shanghai Pulmonary Hospital
Shanghai, 200433
About this study
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.
- To evaluate the clinical and microbiological efficacy and safety of Colistimethate sodium Injection Vial to treat adults with hospital-acquired pneumonia .
- To Learn the pharmacokinetic characteristics of continuous intravenous infusion of Colistimethate sodium.
- Conditions
- Hospital-acquired Pneumonia
- Being tested
- Colistimethate sodium
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colistimethate sodiumDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Colistimethate sodium | Experimental | Not described Receives: Drug: Colistimethate sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per subject clinical cure rate
Measured: 14-28 days
Per subject microbiological cure rate
Measured: 14-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940731
- Sponsor's protocol ID
- CCTQ01458-2-CTF
- Status last verified
- Sep 2013
- First submitted
- 9 Sep 2013
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01940731
- Acronym / sponsor ID
- CCTQ01458-2-CTF
- Conditions
- Hospital-acquired Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (estimated)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To evaluate the clinical and microbiological efficacy and safety of Colistimethate sodium Injection Vial to treat adults with hospital-acquired pneumonia .
- To Learn the pharmacokinetic characteristics of continuous intravenous infusion of Colistimethate sodium.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colistimethate sodium | Experimental | Drug: Colistimethate sodium |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 18-75, either male or female
- 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 .
- Defined as hospital-acquired pneumonia with following criteria
- fever, axillary temperature ≥37.3℃, oral temperature≥37.8℃, tympanic temperature≥38.2℃, rectal temperature≥38.4℃ or hypothermia rectal temperature<35℃
- WBC>10000/μL or <4000μL, neutrophils>70%, rod neutrophils>10%
Key exclusion criteria (23 listed)
- Pneumonia infected within 48h admission.
- Before 72h of admin agents, drug treatment for Systemic antibacterial activity is more than 48 hours, unless clinical treatment failure .
- Patients known or suspected by the single infection of aerobic Gram-positive cocci.
- Patients known to have single or mixed infections by Stenotrophomonas narrow food Aeromonas or Burkholderia.
- Patients with impaired consciousness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colistimethate sodium3-5mg/(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 | Drug | Colistimethate sodium |
Primary outcome
Per subject clinical cure rate
Time frame: 14-28 days
Per subject microbiological cure rate
Time frame: 14-28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colistimethate sodium in people with Hospital-acquired Pneumonia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wu Ju Fang (13816357099, Wujf53@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per subject clinical cure rate (time frame: 14-28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2013.