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

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ClinicalTrials.gov Identifier: NCT03921645
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Sheng Wang MD PhD, Shanghai 10th People's Hospital

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.

Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Multi-antibiotic Resistance Drug: aerosol antibiotics Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aerosol combined group
aerosol combined intravenous antibiotics group,amikacin 15mg/kg, qd
Drug: aerosol antibiotics
use of inhaled Antibacterial drug combined with intravenous antibiotics to treatment multiple drug resistance GNB ventilator associated pneumonia.

No Intervention: No intervention group
this group follow the usual treatment without any intervention



Primary Outcome Measures :
  1. CPIS score changes [ Time Frame: 14 days ]
    use clinical pulmonary infection score scale to evaluate score change from baseline for every patient

  2. renal function changes [ Time Frame: 14 days ]
    record changes in renal function assessed by SCr, blood urea nitrogen,etc.


Secondary Outcome Measures :
  1. ventilator free days in 14 days [ Time Frame: 14 days ]
    record number of days with no ventilator support from day 1 through day 14

  2. 14-day mortality rate [ Time Frame: 14 days ]
    rate of mortality from day 1 to day 14

  3. Drug resistance induction rate [ Time Frame: 14 days ]
    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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921645


Contacts
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Contact: qixing wang, bs 862166307153 wangqixing1221@163.com

Locations
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China, Shanghai
Shanghai tenth people's hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: qixing wang    862166307153    wangqixing1221@163.com   
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Principal Investigator: hao liu, master Shanghai 10th People's Hospital

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Responsible Party: Sheng Wang MD PhD, Director, Principal investigator, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03921645     History of Changes
Other Study ID Numbers: ACAMP
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents