LinezolidPhase 4NCT05944458
Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients
A Phase 4 study testing N acetyl cysteine in people with Linezolid and Antioxidant, run by Helwan University at 1 site in Egypt.
Trial summary
Study the effect of acetylcysteine on decreasing the incidence of LIT in critically ill patients. Study the impact of acetylcysteine on the time to onset of LIT and the time to recovery of platelets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Linezolid, Antioxidant, Thrombocytopenia
- What is being tested?
- N acetyl cysteine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Jun 2025
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18 years)
- Admitted to the Intensive Care Unit (ICU)
- Candidates for intravenous linezolid therapy for ≥ 48 hours
Who cannot join
- Baseline platelet count < 50 × 10⁹/L
- Diagnosis of malignancy
- Receipt of any chemotherapeutic agent within the past 6 months
- Positive COVID-19 RT-PCR test at admission
- Diagnosis of immune thrombocytopenia
- Presence of splenomegaly
Show all 9Show fewer
- Presence of liver cirrhosis
- Presence of hepatitis C
- Refusal to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients: A Double-Blind Randomized Placebo-Controlled Trial
- Study the effect of acetylcysteine on decreasing the incidence of LIT in critically ill patients.
- Study the impact of acetylcysteine on the time to onset of LIT and the time to recovery of platelets.
Read the detailed description
Primary outcome: difference in incidence of LIT between patients who received NAC and patients who didn't.
- Primary outcome definition: Defined as platelets < 150000 OR decrease > 50% of baseline platelets.
- Secondary outcome: difference in Time to onset of LIT and time to recovery between the 2 groups. Blood products transfusion, bleeding, length of stay, and in-hospital mortality incidence between 2 groups.
- Secondary outcome definitions: after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values.
- Conditions
- Linezolid, Antioxidant, Thrombocytopenia, Critical Illness, ICU
- Being tested
- N acetyl cysteine, Placebo
- Medical subject headings
- Thrombocytopenia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N acetyl cysteineDrug
Also called Fluimucil, NAC
Fluimucil 600 mg iv to be taken twice daily as infusion
PlaceboDrug
20 ml normal saline iv every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine group | Active comparator | Generic name: N-acetylcysteine.
* Trade name: Fluimucil.
* Company: Zambon.
* Dosage form: ampoules for intravenous administration.
* Dose: 600mg taken every 12 hours daily with a fixed dose as there is no need for renal or hepatic adjustment, starting with the inception of linezolid therapy.
* Duration: for 14 days post linezolid discontinuation or until ICU discharge, whichever came first. Receives: Drug: N acetyl cysteine |
| Standard of care | Placebo comparator | They will receive standard of care (Platelets monitoring daily, linezolid discontinuation if platelet count less than 50000 or clinically appropriate and platelet transfusion according to the institutional protocol) plus placebo (20 ml normal saline twice daily) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in incidence of LIT between patients who received NAC and patients who didn't.
Defined as platelets < 150000 OR decrease > or = 50% of baseline platelets.
Measured: From starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first.
Secondary outcomes (3)
Blood products transfusion, bleeding, length of ICU stay, and in-ICU mortality incidence between 2 groups.
Measured: From start linezolid until ICU discharge
Difference in time to platelet recovery between the 2 groups
after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values
Measured: From thrombocytopenia onset to recovery, assesed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first
Difference in time to thrombocytopenia onset between the 2 groups
Measured: From linezolid start date until date of first thrombocytopenia event, assessed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Aug 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LinezolidStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdeltawab, Helwan University
- Investigators
- Mohamed Abdeltawab, Pharm D, Principal investigator, Clinical pharmacy, 15 May hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944458
- Sponsor's protocol ID
- 11041990
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2023
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdeltawab M, Ebid AH, Ahmed O, Mobarez MA, Ibrahim M. N-acetylcysteine reduces incidence and duration of linezolid-associated thrombocytopenia in critically ill patients: A randomized controlled trial. Environ Toxicol Pharmacol. 2026 Mar;122:104944. doi: 10.1016/j.etap.2026.104944. Epub 2026 Jan 21.
PubMed 41577060
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients: A Double-Blind Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05944458
- Acronym / sponsor ID
- 11041990
- Conditions
- Linezolid, Antioxidant, Thrombocytopenia, Critical Illness, ICU
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 13 Jul 2023 (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.
- Study the effect of acetylcysteine on decreasing the incidence of LIT in critically ill patients.
- Study the impact of acetylcysteine on the time to onset of LIT and the time to recovery of platelets.
Detailed description
Primary outcome: difference in incidence of LIT between patients who received NAC and patients who didn't.
- Primary outcome definition: Defined as platelets < 150000 OR decrease > 50% of baseline platelets.
- Secondary outcome: difference in Time to onset of LIT and time to recovery between the 2 groups. Blood products transfusion, bleeding, length of stay, and in-hospital mortality incidence between 2 groups.
- Secondary outcome definitions: after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine group | Active comparator | Drug: N acetyl cysteineGeneric name: N-acetylcysteine. * Trade name: Fluimucil. * Company: Zambon. * Dosage form: ampoules for intravenous administration. * Dose: 600mg taken every 12 hours daily with a fixed dose as there is no need for renal or hepatic adjustment, starting with the inception of linezolid therapy. * Duration: for 14 days post linezolid discontinuation or until ICU discharge, whichever came first. |
| Standard of care | Placebo comparator | Drug: PlaceboThey will receive standard of care (Platelets monitoring daily, linezolid discontinuation if platelet count less than 50000 or clinically appropriate and platelet transfusion according to the institutional protocol) plus placebo (20 ml normal saline twice daily) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age ≥ 18 years)
- Admitted to the Intensive Care Unit (ICU)
- Candidates for intravenous linezolid therapy for ≥ 48 hours
Key exclusion criteria (9 listed)
- Baseline platelet count < 50 × 10⁹/L
- Diagnosis of malignancy
- Receipt of any chemotherapeutic agent within the past 6 months
- Positive COVID-19 RT-PCR test at admission
- Diagnosis of immune thrombocytopenia
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 |
|---|---|---|
| N acetyl cysteineAlso: Fluimucil, NACFluimucil 600 mg iv to be taken twice daily as infusion | Drug | N-acetylcysteine group |
| Placebo20 ml normal saline iv every 12 hours | Drug | Standard of care |
Primary outcome
difference in incidence of LIT between patients who received NAC and patients who didn't.
Time frame: From starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first.
Defined as platelets < 150000 OR decrease > or = 50% of baseline platelets.
3 secondary outcomes
Blood products transfusion, bleeding, length of ICU stay, and in-ICU mortality incidence between 2 groups.
Time frame: From start linezolid until ICU discharge
Difference in time to platelet recovery between the 2 groups
Time frame: From thrombocytopenia onset to recovery, assesed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first
Difference in time to thrombocytopenia onset between the 2 groups
Time frame: From linezolid start date until date of first thrombocytopenia event, assessed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first
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 14 Jul 2025.
- Derived from this study: PubMed 41577060Abdeltawab M, Ebid AH, Ahmed O, Mobarez MA, Ibrahim M. N-acetylcysteine reduces incidence and duration of linezolid-associated thrombocytopenia in critically ill patients: A randomized controlled trial. Environ Toxicol Pharmacol. 2026 Mar;122:104944. doi: 10.1016/j.etap.2026.104944. Epub 2026 Jan 21.
- Individual participant dataSharing planned: No
Related trials for Linezolid
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
RecruitingPhase 3
Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)
Diabetic Foot Infection
Not yet recruitingPhase 4
Oral Antibiotic Pharmacokinetics in Young Infants
Linezolid Pharmacokinetics in Young Infants, Pharmacokinetic Analysis
RecruitingPhase 2/3
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
RecruitingPhase 2
Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB
Tuberculosis, Pulmonary
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.
Mohamed Abdeltawab, Pharm D principal investigator
Clinical pharmacy, 15 May hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N acetyl cysteine in people with Linezolid and Antioxidant, run by Helwan 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 9 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 14 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
difference in incidence of LIT between patients who received NAC and patients who didn't. (time frame: From starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05944458, which also lists 1 linked publication.
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 14 Jul 2025.