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Clinical Evaluation of Ampicillin/Sulbactam in Patients with Ventilator Associated Pneumonia

Clinical Evaluation of Two Regimens with Different Doses of Ampicillin/Sulbactam in Patients with Ventilator Associated Pneumonia Caused By Resistant Acinetobacter Baumannii

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180802040665N2
Enrollment
60
Registered
2024-02-28
Start date
2024-03-05
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Ventilator associated Pneumonia. Ventilator associated pneumonia

Interventions

Intervention 1: Intervention group: receiving Meropenem injection at a dose of 1 gram every 8 hours + Colistin injection 4.5 million units every 12 hours + Ampicillin/Sulbactam injection at a dose of

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged more than 18 years old VAP diagnosis according to the IDSA guidelines (new pulmonary infiltration with clinical symptoms including fever, purulent secretions, leukocytosis, and decreased blood oxygen levels occurring after 48 hours of mechanical ventilation). Sign the informed consent form Reporting of resistance Acinetobacter in the pulmonary secretion (concurrent resistance to aminoglycosides, fluoroquinolones, cephalosporins, penicillins and carbapenems). Patients who received empiric antibiotic regimen consist of meropenem (at dose of 1000 mg IV q8h) and vancomycin (at dose of 15 mg/kg IV q12h) for the first 48 hours until the results of the culture are determined.

Exclusion criteria

Exclusion criteria: Breastfeeding and pregnant patients. Patients who have an infection of another source other than the infection caused by the mechanical ventilation device. Obese patients with body mass index more than 35. Patients who have a history of allergy to medicines in the therapeutic regimen. Patients with underlying lung diseases, immunocompromised patients, and those with recurrent lung infection. Patients presenting with sepsis at the commencement of the study, according to the 2021 sepsis campaign guidelines. Individuals with pre-existing pulmonary conditions, such as chronic obstructive pulmonary disease (COPD), lung cancer, or pulmonary thromboembolism (PTE). Patients whose antibiotic treatment may be altered in terms of dosage and administration schedule. Patients experiencing a hypersensitivity reaction during the course of the medication. Patients who have ceased medication for a duration of less than 10 days.

Design outcomes

Primary

MeasureTime frame
The percentage of patients who recovered without changing their antibiotic regimen during the study. Timepoint: 10 days after the start of the study. Method of measurement: Relief of fever, reduction of purulent secretions and no need for vasopressor for at least 48 hours.;Mortality rate. Timepoint: 10 days after the start of the study. Method of measurement: Evaluation of patients' medical records.

Secondary

MeasureTime frame
The percentage of patients who manage to be weaned from mechanical ventilation or tolerate spontaneous breathing mode. Timepoint: 10 days after the start of the study. Method of measurement: Evaluation of patients' ventilators.;Length of stay in ICU. Timepoint: 10 days after the start of the study. Method of measurement: Evaluation of patients' medical records.;Percentage of patients who develop the adverse drug reactions. Timepoint: Daily up to 10 days. Method of measurement: Examination of patients.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Sahraei

Shahid Beheshti University of Medical Sciences

zahra.sahraei@yahoo.com0098218200118

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026