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Status unknownNCT03921645ACAMPUpdated May 7, 2019

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

An interventional study of aerosol antibiotics in Ventilator Associated Pneumonia and Multi-antibiotic Resistance, sponsored by Shanghai 10th People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-05-07.

Sponsored by Shanghai 10th People's Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ventilator Associated Pneumonia
  • Multi-antibiotic Resistance
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 60 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

・After 48 hours of mechanical ventilation diagnosed VAP.

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    aerosol combined group

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

    Drug: aerosol antibiotics

  • No intervention
    No intervention group

    this group follow the usual treatment without any intervention

Interventions

  • Drugaerosol antibiotics

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

06

What researchers measure

Primary outcomes

  1. CPIS score changes

    use clinical pulmonary infection score scale to evaluate score change from baseline for every patient

    Time frame: 14 days

  2. renal function changes

    record changes in renal function assessed by SCr, blood urea nitrogen,etc.

    Time frame: 14 days

Secondary outcomes

  1. ventilator free days in 14 days

    record number of days with no ventilator support from day 1 through day 14

    Time frame: 14 days

  2. 14-day mortality rate

    rate of mortality from day 1 to day 14

    Time frame: 14 days

  3. Drug resistance induction rate

    Drug resistance induction rate is The number of cases of antibiotic-resistant species from the previous increase divided by the total number of patients included

    Time frame: 14 days

07

Study locations

1 of 1 sites recruiting
  • Shanghai tenth people's hospital
    Shanghai, Shanghai 200072, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03921645
Lead sponsor
Shanghai 10th People's Hospital
Responsible party
Sheng Wang MD PhD (Director, Principal investigator, Shanghai 10th People's Hospital) — Principal investigator
First posted
Apr 19, 2019
Start date
Jan 1, 2018
Primary completion
Dec 30, 2019 (estimated)
Completion
Jan 1, 2020 (estimated)
Last update
May 7, 2019

Study contacts

qixing wang, bs
Contact
wangqixing1221@163.com
862166307153
hao liu, master
principal investigator · Shanghai 10th People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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