Effect of Montelukast Versus Co Enzyme in Sepsis

NCT05293132 | Completed Phase 2

• 1 other identifier: RHDIRB2020110301 REC # 50
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is a leading cause of morbidity and mortality in intensive care units. Sepsis is a life-threatening organ dysfunction linked to a dysregulated host response to infection. It leads to overwhelming of systemic inflammation causing release of proinflammatory cytokines, which trigger overproduction of reactive oxygen species. Several animal studies with sepsis proved the effectiveness of montelukast and coenzyme Q10 as anti-inflammatory and antioxidants in preventing end organ damage, deterioration, and reducing mortality. Therefore, a clinical trial will be carried out to compare the efficacy and safety of montelukast versus co enzyme Q10 on the clinical outcome in patients with sepsis.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Twenty-eight-day mortality

  All patients will be followed up in the ICU and by phone calls after discharge. The 28-day mortality rate will be evaluated and recorded.

  Starting from the randomization date up to 28 days

Secondary Outcomes (12)

• Sequential organ failure assessment score

  Starting from the randomization date,on day 3, on day7, and then every 3 days till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days.

• C- reactive protein

  Starting from the randomization date,on day 3, and on day7

• Heart rate

  Starting from the randomization date till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days.

• ICU length of stay

  Starting from the randomization date till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days.

• Length of hospital stay

  Starting from the randomization date till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days.

Study Arms (3)

Montelukast group

EXPERIMENTAL

30 patients will receive montelukast sodium 10 mg/day film coated tablets (Singulair®; Merck \& Co Inc) or (Clear air®; Amoun Pharmaceutical Company S.A.E., Egypt) in addition to the standard sepsis treatment starting from the onset of the diagnosis of sepsis till discharge from ICU, or death.

Drug: Montelukast Sodium 10 mg; Drug: Standard Treatment

Co Enzyme Q10 group

EXPERIMENTAL

30 patients will receive co enzyme Q10 capsule 210 mg / day (MEPACO Pharmaceutical Company (Egypt) in addition to the standard sepsis treatment starting from the onset of the diagnosis of sepsis till discharge from ICU, or death.

Drug: Co-Enzyme Q10; Drug: Standard Treatment

Control group

ACTIVE COMPARATOR

30 patients will receive the standard treatment of sepsis from the onset of the diagnosis of sepsis till discharge from ICU, or death.

Drug: Standard Treatment

Interventions

Montelukast Sodium 10 mg DRUG

Film coated tablets containing 10 mg montelukast

Also known as: (Singulair®; Merck & Co Inc) or (Clear air®; Amoun Pharmaceutical Company S.A.E., Egypt)

Montelukast group

Co-Enzyme Q10 DRUG

Capsules contain 210 mg Co-Enzyme Q10

Also known as: Co enzyme Q10(MEPACO Pharmaceutical Company (Egypt)

Co Enzyme Q10 group

Standard Treatment DRUG

Standard sepsis treatment includes fluid resuscitation, early administration of intravenous broad spectrum antibiotic (ceftriaxone 2gm/24 hour or meropenem 1g/8 hours, linezolid 600/12hours) till obtaining the microbiological culture to narrow the coverage, paracetamol intravenous antipyretic (paracetamol 1gm/8 hours) till no fever and temperature less than 380c, and prophylactic anticoagulant low molecular weight heparin (enoxaparin 40/24 hours), prophylactic stress ulcer (pantoprazole 40mg/24hours)

Also known as: Standard sepsis treatment

Co Enzyme Q10 group; Control group; Montelukast group

Eligibility Criteria

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

You may qualify if:

• Age \>18 years old.
• Males and females
• Confirmed diagnosis of sepsis according to the third sepsis definition which include documented or suspected infection, plus an acute change in total SOFA score ≥ 2 points

You may not qualify if:

• Pregnancy
• A severe moribund state
• An anticipated ICU stay of less than 24 hours.
• Patients with a history of hypersensitivity to montelukast or co enzyme Q10.
• Patients with systemic eosinophilia in the blood or vasculitis.
• Patients with neuropsychiatric diseases as hallucinations, depression or suicidal thoughts that put the patient at risk when participating in the study.
• Unable to receive enteral medications.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ghada El Adly

Cairo, 112311, Egypt

Location

Related Publications (1)

• Eladly GH, Amin SOE, Sabri NA, Shawki MA. The clinical outcome of Montelukast versus co-enzyme Q10 in adult patients with sepsis: A randomized controlled clinical trial. J Crit Care. 2026 Feb;91:155225. doi: 10.1016/j.jcrc.2025.155225. Epub 2025 Aug 21.

  PMID: 40845766 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

montelukast; coenzyme Q10

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Salwa om Amin, PHD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 24, 2022
• Study Start: February 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

EG (1)