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Evaluation of Meropenem efficacy as bolus infusion , In the treatment of patients with Ventilator-Associated Pneumonia with Accelerated Creatinine Clearance

Evaluation of meropenem efficacy as bolus (30 minute) infusion Versus Prolonged (3-Hours) Infusion in the Treatment of Ventilator-Associated Pneumonia(VAP) in Patients with Augmented Renal Clearance(ARC): A Pilot phase of a Clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260201068728N1
Enrollment
20
Registered
2026-04-08
Start date
2026-02-14
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Ventilator-Associated Pneumonia. Condition 2: Augmented Renal Clearance. Ventilator associated pneumonia

Interventions

Intervention 1: Intervention group: 9g Meropenem in a day as a 30-minute bolus, 9vials of ( Afapenem 1g) will be administered , every vial diluted in 5-20 ml of normal saline and administered as 3g

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Patients with Augmented Renal Clearance (creatinine clearance greater than 130 mL/min/1.73 m2 body surface area) based on ( ARC score ,ARCTIC score) Individuals who have developed Ventilator-Associated Pneumonia (48 hours after intubation) according to CPIS criteria and require treatment with the Meropenem antibiotic. With chest radiography (one of: CT, MRI, CXR) that proves the presence of new or progressive bacterial infiltrates in the 48 hours prior to the study.

Exclusion criteria

Exclusion criteria: Decreased or no urination Being on Dialysis Pregnancy Allergy to Beta-Lactams Patients who have been treated with another Antibiotic more than 24 hours ago Serum Creatinine greater than 1.3 mg/dl

Design outcomes

Primary

MeasureTime frame
Duration of treatment. Timepoint: Days 1,2,3,4,4,5,6,7. Method of measurement: The number of days the patient receives antibiotics.;Duration of mechanical ventilation. Timepoint: Days 1,2,3,4,4,5,6,7. Method of measurement: The number of days the patient is ventilator dependent.;Mortality. Timepoint: Days 1,2,3,4,4,5,6,7. Method of measurement: Death of patients.;SOFA score. Timepoint: Days 1,2,3,4,4,5,6,7. Method of measurement: The tool assesses vital organ dysfunction in patients in the Intensive Care Unit (ICU) and helps predict the risk of death. The tool assesses six vital organ systems, and the higher the score, the higher the risk of death.;ARC score. Timepoint: Day 1. Method of measurement: It is a clinical tool to predict the likelihood of increased renal clearance (ARC) in patients. It is calculated based on factors such as age under 50 years, trauma, SOFA score less than 4. A total score above 6 indicates a high probability of ARC.;Creatinine clearance. Timepoint: Days1,3,7. Method of measurement: Based on the patient's 8-hour urine collection from 12 midnight to 8 am.;Clinical Improvement. Timepoint: Days 1,2,3,4,4,5,6,7. Method of measurement: Complete or partial improvement of leukocytosis, fever, PaO2 / FiO2, clinical signs and symptoms within 48-72 hours after treatment of the infection, as confirmed by a specialist physician.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPardis Aghaebrahimi Samani

Ahvaz University of Medical Sciences

aghaebrahimi.P@ajums.ac.ir+98 61 3320 4501

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026