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

Tongji University

Status: Unknown

Conditions: Ventilator Associated Pneumonia; Multi-antibiotic Resistance

Treatments: Drug: aerosol antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT03921645

ACAMP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

aerosol combined group

Experimental group

Description:

aerosol combined intravenous antibiotics group，amikacin 15mg/kg, qd

Treatment:

Drug: aerosol antibiotics

No intervention group

No Intervention group

Description:

this group follow the usual treatment without any intervention