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Evaluation of the Role of Acetyl Cysteine in Ventilator Associated Pneumonia by Carbapenem Resistance Klebsiella

Evaluation of the Role of Acetyl Cysteine in The Treatment of Ventilator Associated Pneumonia Induced by Carbapenem Resistance Klebsiella

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07097727
Enrollment
70
Registered
2025-07-31
Start date
2023-10-30
Completion date
2024-10-30
Last updated
2025-07-31

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

Conditions

Mechanical Ventilation, Ventilator Associated Pneumonia ( VAP)

Keywords

Multi drug resistance, Ventilator-associated pneumonia, mechanical ventilation, carbapenem

Brief summary

The aim of the study is to evaluate the role of addition of Acetyl cysteine in the management of VAP induced by carbapenem resistant klebsiella. The primary outcome indicator is the change in modified clinical pulmonary infection score. The secondary outcome indicator is duration of mechanical ventilation.

Detailed description

Ventilator-associated pneumonia remains the most common intensive care unit infection of patients on mechanical ventilation, and is associated with substantial morbidity/mortality, a longer hospital stays, and increased healthcare costs. Multi drug resistance bacterial infection in Ventilator-associated pneumonia patients presents a global challenge due to its increasing morbidity and mortality. Multi drug resistance is defined as acquired nonsusceptibility to at least one agent in ≥ three antimicrobial categories according to the European Center for Disease Prevention and Control, The most common (80%) Ventilator-associated pneumonia pathogens were Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae. Klebsiella pneumoniae is a common pathogen for community-and hospital-acquired infections, such as pneumonia, urinary tract infection, and bacteremia. Infections due to Multi drug resistance Klebsiella species Were found to be associated with high mortality and hospital outbreaks. Carbapenem-resistant Klebsiella pneumoniae is among the bacteria that the World Health Organization gives critical priority to and poses the greatest threat to human health. According to China Antimicrobial Surveillance Network, carbapenem resistance in Klebsiella pneumoniae increased rapidly from 3% in 2005 to more than 25% in 2019. In case of new drugs unavailable or not active invitro, guidelines recommend combination of drugs active invitro (o polymyxins, aminoglycosides, tigecycline or Fosfomycin) with no recommendation for or against specific combinations. In case of severe infections caused by Carbapenem-resistant Klebsiella carrying metallo-blactamases, guidelines recommend aztreonam and ceftazidimeavibactam combination therapy. Several studies demonstrated that acetyl Cysteine when added to antibacterial agent invitro, potentiates the antibacterial compound activities. The role of acetyl cystiene antioxidant and anti-inflammatory activities is being widely investigated in viral infections. Since the mechanisms of acetyl cystiene effects in viral infections include its antioxidant and anti-inflammatory activities, they may also be beneficial in bacterial Multi drug resistance bacterial infections, The hypothesis of this study is that addition of acetyl cysteine to antibiotics in vivo could have a synergistic effect in Multi drug resistance bacterial infections and could help in decreasing high doses of antibiotics required, improving outcome and decrease hospital stay.

Interventions

DRUGacetyl cysteine 600 mg

patients received acetyl cysteine 600 mg/ 12h IV in addition to antibiotics

DRUGantibiotics and saline.

patients received only antibiotics and saline

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients who are mechanically ventilated * Age from 21 to 65 * Both sexes.

Exclusion criteria

* Patient guardians who refuse the consent • Hypersensitivity to acetyl Cysteine. * Extrapulmonary infection. * Cardiac patient with chronic heart failure * Patient with lung diseases (tumors, tuberculosis, ,Chronic Obstructive Pulmonary Disease, Bronchiectasis and lung fibrosis) * Severe immunosuppression (total leucocyte \< 1000 mm3 or neutrophil \< 500 cell/mm3. * Patients on steroid or immunosuppressive drugs.

Design outcomes

Primary

MeasureTime frameDescription
Improvement of clinical pulmonary infection score.14 daysImprovement of clinical pulmonary infection score . score calculated in day 14 of treatment

Secondary

MeasureTime frameDescription
Duration of mechanical ventilation ventilation.14 daysDuration of mechanical ventilation
mortality rate14 daysIncidence of mortality

Countries

Egypt

Outcome results

None listed

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