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

NCT07097727 | Completed Phase 1

• 1 other identifier: 36264MS321/9/23
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia ( VAP); Mechanical Ventilation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Improvement of clinical pulmonary infection score.

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

  14 days

Secondary Outcomes (2)

• Duration of mechanical ventilation ventilation.

  14 days

• mortality rate

  14 days

Study Arms (2)

acetyl cysteine 600 mg

EXPERIMENTAL

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

Drug: acetyl cysteine 600 mg

antibiotics and saline

EXPERIMENTAL

patients received only antibiotics and saline.

Drug: antibiotics and saline.

Interventions

acetyl cysteine 600 mg DRUG

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

Also known as: Group 1:intravenous infusion of acetyl cysteine 600 mg

acetyl cysteine 600 mg

antibiotics and saline. DRUG

patients received only antibiotics and saline

Also known as: Group 2 :antibiotics and intravenous infusion of 200 ml glucose 5%

antibiotics and saline

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Acetylcysteine; Anti-Bacterial Agents; Sodium Chloride

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Wessam Elfeky, Resident

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 31, 2025
• Study Start: October 30, 2023
• Primary Completion: September 30, 2024
• Study Completion: October 30, 2024
• Last Updated: July 31, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months

Locations

EG (1)