Ventilator Associated Pneumonia ( VAP)Phase 1NCT07097727
Evaluation of the Role of Acetyl Cysteine in Ventilator Associated Pneumonia by Carbapenem Resistance Klebsiella
A Phase 1 study testing acetyl cysteine 600 mg and antibiotics and saline. in people with Ventilator Associated Pneumonia ( VAP) and Mechanical Ventilation, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Ventilator Associated Pneumonia ( VAP), Mechanical Ventilation
- What is being tested?
- acetyl cysteine 600 mg and antibiotics and saline.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2023to 30 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are mechanically ventilated
- Age from 21 to 65
- Both sexes.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Role of Acetyl Cysteine in The Treatment of Ventilator Associated Pneumonia Induced by Carbapenem Resistance Klebsiella
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.
Read the 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.
- Being tested
- acetyl cysteine 600 mg, antibiotics and saline.
- Keywords
- Multi drug resistance, Ventilator-associated pneumonia, mechanical ventilation, carbapenem
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetyl cysteine 600 mgDrug
Also called Group 1:intravenous infusion of acetyl cysteine 600 mg
patients received acetyl cysteine 600 mg/ 12h IV in addition to antibiotics
antibiotics and saline.Drug
Also called Group 2 :antibiotics and intravenous infusion of 200 ml glucose 5%
patients received only antibiotics and saline
| Study group | Role | What they receive |
|---|---|---|
| acetyl cysteine 600 mg | Experimental | patients received acetyl cysteine 600 mg/ 12h IV in addition to antibiotics Receives: Drug: acetyl cysteine 600 mg |
| antibiotics and saline | Experimental | patients received only antibiotics and saline. Receives: Drug: antibiotics and saline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of clinical pulmonary infection score.
Improvement of clinical pulmonary infection score . score calculated in day 14 of treatment
Measured: 14 days
Secondary outcomes (2)
Duration of mechanical ventilation ventilation.
Duration of mechanical ventilation
Measured: 14 days
mortality rate
Incidence of mortality
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start30 Oct 2023
- Primary completion30 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated Pneumonia ( VAP)Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wessam Ibrahim Elfeky, Tanta University
- Investigators
- Wessam Elfeky, Resident, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097727
- Sponsor's protocol ID
- 36264MS321/9/23
- Status last verified
- Oct 2023
- First submitted
- 11 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Acetyl Cysteine in The Treatment of Ventilator Associated Pneumonia Induced by Carbapenem Resistance Klebsiella
- ClinicalTrials.gov ID
- NCT07097727
- Acronym / sponsor ID
- 36264MS321/9/23
- Keywords
- Multi drug resistance, Ventilator-associated pneumonia, mechanical ventilation, carbapenem
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetyl cysteine 600 mg | Experimental | Drug: acetyl cysteine 600 mgpatients received acetyl cysteine 600 mg/ 12h IV in addition to antibiotics |
| antibiotics and saline | Experimental | Drug: antibiotics and saline.patients received only antibiotics and saline. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are mechanically ventilated
- Age from 21 to 65
- Both sexes.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetyl cysteine 600 mgAlso: Group 1:intravenous infusion of acetyl cysteine 600 mgpatients received acetyl cysteine 600 mg/ 12h IV in addition to antibiotics | Drug | acetyl cysteine 600 mg |
| antibiotics and saline.Also: Group 2 :antibiotics and intravenous infusion of 200 ml glucose 5%patients received only antibiotics and saline | Drug | antibiotics and saline |
Primary outcome
Improvement of clinical pulmonary infection score.
Time frame: 14 days
Improvement of clinical pulmonary infection score . score calculated in day 14 of treatment
2 secondary outcomes
Duration of mechanical ventilation ventilation.
Time frame: 14 days
mortality rate
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wessam Elfeky, Resident principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing acetyl cysteine 600 mg and antibiotics and saline. in people with Ventilator Associated Pneumonia ( VAP) and Mechanical Ventilation, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of clinical pulmonary infection score. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.