Clinical trial

The Effect of Montelukast Versus Co Enzyme Q10 on the Clinical Outcome of Patients With Sepsis

Name

RHDIRB2020110301 REC # 50

Description

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.

Trial arms

Trial start

2022-02-01

Estimated PCD

2023-06-01

Trial end

2023-06-01

Status

Completed

Phase

Early phase I

Treatment

Montelukast Sodium 10 mg

Film coated tablets containing 10 mg montelukast

Arms:

Montelukast group

Other names:

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

Co-Enzyme Q10

Capsules contain 210 mg Co-Enzyme Q10

Arms:

Co Enzyme Q10 group

Other names:

Co enzyme Q10(MEPACO Pharmaceutical Company (Egypt)

Standard Treatment

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)

Arms:

Co Enzyme Q10 group, Control group, Montelukast group

Other names:

Standard sepsis treatment

Size

Primary endpoint

Twenty-eight-day mortality

Starting from the randomization date up to 28 days

Eligibility criteria

Inclusion Criteria: 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 Exclusion Criteria: * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

Updated at

2023-07-20

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product