Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
ACAMP
1 other identifier
interventional
60
1 country
1
Brief Summary
To investigate use of aerosol combined with intravenous antibiotics for the treat of multi-drug resistance gram negative bacterias diagnosed ventilator-associated pneumonia in intensive care unit in a hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Typical duration for not_applicable
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
November 20, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedFirst Posted
Study publicly available on registry
April 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedMay 7, 2019
April 1, 2019
2 years
November 20, 2017
May 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
CPIS score changes
use clinical pulmonary infection score scale to evaluate score change from baseline for every patient
14 days
renal function changes
record changes in renal function assessed by SCr, blood urea nitrogen,etc.
14 days
Secondary Outcomes (3)
ventilator free days in 14 days
14 days
14-day mortality rate
14 days
Drug resistance induction rate
14 days
Study Arms (2)
aerosol combined group
EXPERIMENTALaerosol combined intravenous antibiotics group，amikacin 15mg/kg, qd
No intervention group
NO INTERVENTIONthis group follow the usual treatment without any intervention
Interventions
use of inhaled Antibacterial drug combined with intravenous antibiotics to treatment multiple drug resistance GNB ventilator associated pneumonia.
Eligibility Criteria
You may qualify if:
- ・After 48 hours of mechanical ventilation diagnosed VAP.
You may not qualify if:
- Maternal
- who not meet the age limits,
- used amikacin within 15 days,
- allergic to amikacin,
- APACHE II score \> 35,
- severe neutropenia unrelated to sepsis or meningitis,
- unable to retain specimens
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai tenth people's hospital
Shanghai, Shanghai Municipality, 200072, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
hao liu, master
Shanghai 10th People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Principal investigator
Study Record Dates
First Submitted
November 20, 2017
First Posted
April 19, 2019
Study Start
January 1, 2018
Primary Completion
December 30, 2019
Study Completion
January 1, 2020
Last Updated
May 7, 2019
Record last verified: 2019-04