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The Effect of Nebulization of Alkaline Solution on Treating XDRAB Pneumonia With C/S Plus Minocycline (NAEDRAP)

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ClinicalTrials.gov Identifier: NCT02060149
Recruitment Status : Unknown
Verified February 2014 by songlq, Xijing Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
songlq, Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: C/S plus minocycline. Drug: nebulization with pH 7.4 solution Drug: nebulization with pH 7.8 solution Drug: No nebulization Phase 1 Phase 2

Detailed Description:
Pneumonia patients with XDRAB are eligible for this multicenter study, do not meet the exclusion criteria and will sign the informed consent. They will received the anti-infection protocol with Cefoperazone/ sulbactam 3.0g(intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h). All enrolled patients were randomly divided into three groups according to the difference in pH value of aerosol inhalation with sodium bicarbonate solution. Group one is blank-control and patients will received usual antibiotic treatment without inhalation. The pH value in group two is 7.4 and that in group is 7.8. Each time the volume of aerosol solution is 5ml, q8h. The average course of treatment will be two weeks. Clinical indexes will be collected including vital signs, pulmonary rales, cough level, expectoration level, sputum color,blood count, arterial blood gas, biochemical parameters, chest X-ray score, APACHE II score, clinical pulmonary infection score, ECG, sputum culture, et al.The primary endpoints are pathogenic clearance rate and recovery rate. The secondary end point is adverse reaction rate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Nebulization of Alkaline Solution on Treating Extensively Drug Resistant A. Baumannii Pneumonia With Cefoperazone and Sulbactam Plus Minocycline: A Multi-center Randomized Study
Study Start Date : March 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Sham Comparator: no nebulization
Antibiotics 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.
Drug: C/S plus minocycline.
Cefoperazone/ sulbactam 3.0g(intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h).
Other Name: CEFOPERAZONE SODIUM AND SULBACTAM SODIUM FOR INJECTION

Drug: No nebulization
No nebulization will be given to the patients.
Other Name: sham

Active Comparator: nebulization with pH 7.4 solution
Patients 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).
Drug: C/S plus minocycline.
Cefoperazone/ sulbactam 3.0g(intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h).
Other Name: CEFOPERAZONE SODIUM AND SULBACTAM SODIUM FOR INJECTION

Drug: nebulization with pH 7.4 solution
Patients will receive the nebulization with Sodium Bicarbonate of pH 7.4 (Each time the volume of aerosol solution is 5ml, q8h).
Other Name: Sodium Bicarbonate

Experimental: nebulization with pH 7.8 solution
Patients 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).
Drug: C/S plus minocycline.
Cefoperazone/ sulbactam 3.0g(intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h).
Other Name: CEFOPERAZONE SODIUM AND SULBACTAM SODIUM FOR INJECTION

Drug: nebulization with pH 7.8 solution
Patients will receive the nebulization with Sodium Bicarbonate of pH 7.8 (Each time the volume of aerosol solution is 5ml, q8h).
Other Name: Sodium Bicarbonate




Primary Outcome Measures :
  1. Pathogenic Clearance rate and recovery rate [ Time Frame: one treatment course for about two weeks ]

Secondary Outcome Measures :
  1. adverse reaction rate [ Time Frame: one treatment course for about two weeks ]

Other Outcome Measures:
  1. hospital time and mortality [ Time Frame: about four weeks ]


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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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 ClinicalTrials.gov identifier (NCT number): NCT02060149


Contacts
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Contact: Juan Wang, master 18909233806 ddys1211@163.com

Locations
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China, Shaanxi
Xijing Hospital Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: zhikui li, doctor    13571855922    lizhikui@fmmu.edu.cn   
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: liqiang song, doctor first affiliated hospital, fourth military medical university

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Responsible Party: songlq, vice director of department of respiratory and criticle care medicine, Xijing Hospital
ClinicalTrials.gov Identifier: NCT02060149     History of Changes
Other Study ID Numbers: xjhx-song1
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by songlq, Xijing Hospital:
Extensively Drug Resistant A. Baumannii

Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Minocycline
Sulbactam
Cefoperazone
Sulperazone
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents