The Effect of Nebulization of Alkaline Solution on Treating XDRAB Pneumonia With C/S Plus Minocycline
NAEDRAP
1 other identifier
interventional
90
1 country
1
Brief Summary
The mortality of pneumonia with extensively drug resistant Acinetobacter baumannii (XDRAB) is still high, even if these patients received certain strong anti-infection treatment such us the combination of cefoperazone-sulbactam (C/S) and minocycline. Health airway lining fluid is mildly alkaline but airway acidification usually appears for the infection of XDRAB. The hypothesis is offered that the biologic activity of XDRAB might be inhibited if the circumstance including pH is changed. In the vitro study we observed that the inhibit effect of antibiotics on XDRAB growth was improved significantly by alkaline solution within the scope of physiology. So the aim of this clinical study is to explore the effects of nebulization of alkaline Solution on C/S plus minocycline on the pneumonia with XDRAB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2013
CompletedFirst Posted
Study publicly available on registry
February 11, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFebruary 11, 2014
February 1, 2014
1 year
March 10, 2013
February 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathogenic Clearance rate and recovery rate
one treatment course for about two weeks
Secondary Outcomes (1)
adverse reaction rate
one treatment course for about two weeks
Other Outcomes (1)
hospital time and mortality
about four weeks
Study Arms (3)
no nebulization
SHAM COMPARATORAntibiotics protocol is C/S plus minocycline. That is Cefoperazone/ sulbactam 3.0g（intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral,q12h).No nebulization will given to these patients.
nebulization with pH 7.4 solution
ACTIVE COMPARATORPatients will received the same antibiotics protocol with C/S plus minocycline and nebulization with pH 7.4 solution(Each time the volume of aerosol solution is 5ml, q8h).
nebulization with pH 7.8 solution
EXPERIMENTALPatients will received the same antibiotics protocol with C/S plus minocycline and nebulization with pH 7.8 solution(Each time the volume of aerosol solution is 5ml, q8h).
Interventions
Cefoperazone/ sulbactam 3.0g（intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h).
Patients will receive the nebulization with Sodium Bicarbonate of pH 7.4 (Each time the volume of aerosol solution is 5ml, q8h).
Patients will receive the nebulization with Sodium Bicarbonate of pH 7.8 (Each time the volume of aerosol solution is 5ml, q8h).
Eligibility Criteria
You may qualify if:
- Age: 18 to 75 years old, male or female
- The pneumonia patients met the diagnostic criteria, and clinical pulmonary infection score (CPIS) ≥ 5;
- The sputum bacteriology detection only prompted Acinetobacter baumannii culture for pathogens concentration meets the diagnostic criteria of the Chinese hospital-acquired pneumonia diagnosis and treatment guidelines, 2002 edition of "Acinetobacter baumannii and susceptibility results show only 1 to 2 sensitive to antimicrobial drugs (polymyxin, minocycline or tegafur doxycycline);
- Cephalosporins or tetracyclines drug treatment without a history of allergies and contraindications;
- Be able to accept inhalation therapy.
- Informed consent gained
You may not qualify if:
- Refused to accept inhalation therapy
- Renal insufficiency, creatinine clearance (Cockcroft-Gault formula) (CLcr) 15 ml / min or less;
- Liver dysfunction, defined as Child-Pugh score B or C
- Within one week before the start of cefoperazone sulbactam, minocycline treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
liqiang song, doctor
first affiliated hospital, fourth military medical university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice director of department of respiratory and criticle care medicine
Study Record Dates
First Submitted
March 10, 2013
First Posted
February 11, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
February 11, 2014
Record last verified: 2014-02