PneumoniaPhase 1/2NAEDRAPNCT02060149
The Effect of Nebulization of Alkaline Solution on Treating XDRAB Pneumonia With C/S Plus Minocycline
A Phase 1/2 study testing C/S plus minocycline., nebulization with pH 7.4 solution and nebulization with pH 7.8 solution in people with Pneumonia, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- C/S plus minocycline., nebulization with pH 7.4 solution and nebulization with pH 7.8 solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Apr 2015
- Phase
- Phase 1/2
- 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital
Xi'an, Shaanxi, 710032
zhikui li, doctor, 13571855922, lizhikui@fmmu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- C/S plus minocycline., nebulization with pH 7.4 solution, nebulization with pH 7.8 solution, No nebulization
- Keywords
- Extensively Drug Resistant A. Baumannii
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C/S plus minocycline.Drug
Also called CEFOPERAZONE SODIUM AND SULBACTAM SODIUM FOR INJECTION
Cefoperazone/ sulbactam 3.0g（intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h).
nebulization with pH 7.4 solutionDrug
Also called Sodium Bicarbonate
Patients will receive the nebulization with Sodium Bicarbonate of pH 7.4 (Each time the volume of aerosol solution is 5ml, q8h).
nebulization with pH 7.8 solutionDrug
Also called Sodium Bicarbonate
Patients will receive the nebulization with Sodium Bicarbonate of pH 7.8 (Each time the volume of aerosol solution is 5ml, q8h).
No nebulizationDrug
Also called sham
No nebulization will be given to the patients.
| Study group | Role | What they receive |
|---|---|---|
| no nebulization | Sham comparator | 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. Receives: Drug: C/S plus minocycline.; Drug: No nebulization |
| nebulization with pH 7.4 solution | Active comparator | 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). Receives: Drug: C/S plus minocycline.; Drug: nebulization with pH 7.4 solution |
| nebulization with pH 7.8 solution | Experimental | 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). Receives: Drug: C/S plus minocycline.; Drug: nebulization with pH 7.8 solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogenic Clearance rate and recovery rate
Measured: one treatment course for about two weeks
Secondary outcomes (1)
adverse reaction rate
Measured: one treatment course for about two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, songlq, Xijing Hospital
- Investigators
- liqiang song, doctor, Principal investigator, first affiliated hospital, fourth military medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060149
- Sponsor's protocol ID
- xjhx-song1
- Acronym
- NAEDRAP
- Status last verified
- Feb 2014
- First submitted
- 10 Mar 2013
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02060149
- Acronym / sponsor ID
- NAEDRAP / xjhx-song1
- Conditions
- Pneumonia
- Keywords
- Extensively Drug Resistant A. Baumannii
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 11 Feb 2014 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no nebulization | Sham comparator | Drug: C/S plus minocycline., Drug: No nebulizationAntibiotics 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 comparator | Drug: C/S plus minocycline., Drug: nebulization with pH 7.4 solutionPatients 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 | Experimental | Drug: C/S plus minocycline., Drug: nebulization with pH 7.8 solutionPatients 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| C/S plus minocycline.Also: CEFOPERAZONE SODIUM AND SULBACTAM SODIUM FOR INJECTIONCefoperazone/ sulbactam 3.0g（intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h). | Drug | nebulization with pH 7.4 solution, nebulization with pH 7.8 solution, no nebulization |
| nebulization with pH 7.4 solutionAlso: Sodium BicarbonatePatients will receive the nebulization with Sodium Bicarbonate of pH 7.4 (Each time the volume of aerosol solution is 5ml, q8h). | Drug | nebulization with pH 7.4 solution |
| nebulization with pH 7.8 solutionAlso: Sodium BicarbonatePatients will receive the nebulization with Sodium Bicarbonate of pH 7.8 (Each time the volume of aerosol solution is 5ml, q8h). | Drug | nebulization with pH 7.8 solution |
| No nebulizationAlso: shamNo nebulization will be given to the patients. | Drug | no nebulization |
Primary outcome
Pathogenic Clearance rate and recovery rate
Time frame: one treatment course for about two weeks
1 secondary outcome
adverse reaction rate
Time frame: one treatment course for about two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
Related trials for Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
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.
liqiang song, doctor principal investigator
first affiliated hospital, fourth military medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing C/S plus minocycline., nebulization with pH 7.4 solution and nebulization with pH 7.8 solution in people with Pneumonia, run by Xijing Hospital at 1 site 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 6 inclusion and 4 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 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Juan Wang, master (18909233806, ddys1211@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathogenic Clearance rate and recovery rate (time frame: one treatment course for about two weeks). 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 11 Feb 2014.