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Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia

Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03921645
Acronym
ACAMP
Enrollment
60
Registered
2019-04-19
Start date
2018-01-01
Completion date
2020-01-01
Last updated
2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multi-antibiotic Resistance, Ventilator Associated Pneumonia

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.

Detailed description

Ventilator-associated pneumonia (VAP) refers to the endotracheal tube or tracheostomy patients pneumonia after 48h of mechanical ventilation, mechanical ventilation is one of the most common and most serious complications, hospital acquired is An important cause of pneumonia. According to the onset time of VAP, VAP can be divided into early-onset VAP and late-onset VAP. The time limit is mechanical ventilation for 4 days, in which early-onset VAP (mechanical ventilation ≤ 4d) is mainly caused by pathogens sensitive to most antibacterial drugs (such as methicillin-sensitive Staphylococcus aureus, Streptococcus pneumoniae, etc.); late-onset VAP ≥ 5D occur during mechanical ventilation, mainly caused by multi-drug resistant (multi-drug resistance, MDR) (such as P. aeruginosa, Acinetobacter baumannii, methicillin-resistant Staphylococcus aureus). Some early-onset VAPs can also be caused by MDR. Therefore, MDR has become the main pathogen of VAP, especially Gram-negative bacilli. Studies have shown that VDR caused by MDR has a mortality rate of 76% and an attributable mortality rate of 20-30%. Such bacteria are not sensitive to commonly used antibacterial drugs in the clinic, and sensitive antibiotics, such as aminoglycosides, have a large systemic side effect, thereby limiting clinical use. Therefore, in theory, nebulized inhaled sensitive antibiotics can achieve high drug concentrations in lung tissue, and lower blood concentrations can avoid or reduce systemic side effects.

Interventions

DRUGaerosol antibiotics

use of inhaled Antibacterial drug combined with intravenous antibiotics to treatment multiple drug resistance GNB ventilator associated pneumonia.

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

・After 48 hours of mechanical ventilation diagnosed VAP.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
CPIS score changes14 daysuse clinical pulmonary infection score scale to evaluate score change from baseline for every patient
renal function changes14 daysrecord changes in renal function assessed by SCr, blood urea nitrogen,etc.

Secondary

MeasureTime frameDescription
ventilator free days in 14 days14 daysrecord number of days with no ventilator support from day 1 through day 14
14-day mortality rate14 daysrate of mortality from day 1 to day 14
Drug resistance induction rate14 daysDrug resistance induction rate is The number of cases of antibiotic-resistant species from the previous increase divided by the total number of patients included

Countries

China

Contacts

Primary Contactqixing wang, bs
wangqixing1221@163.com862166307153

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026