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Antibiotic regimens for treatment of resistant pneumonia

Comparing efficacy and safety of Meropenem/Ampicillin-sulbactam and Meropenem/Colistin in treatment of ventilator associated pneumonia due to resistant gram negative microorganisms

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201509213449N19
Enrollment
20
Registered
2015-12-04
Start date
2015-09-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: Pneumonia. Condition 2: Pneumonia. Condition 3: Pneumonia. Pneumonia due to Klebsiella pneumoniae Pneumonia due to Pseudomonas Pneumonia due to other aerobic Gram-negative bacteria

Interventions

Intervention 1: Colistin 9MIU loading dose as iv infusion over 1 hour then 4.5MIU every 12 hour as iv infusion over 1 hour+Meropenem 2g every 8 hour as iv infusion over 3 hours for 14 days. Interventi
Treatment - Drugs
Colistin 9MIU loading dose as iv infusion over 1 hour then 4.5MIU every 12 hour as iv infusion over 1 hour+Meropenem 2g every 8 hour as iv infusion over 3 hours for 14 days
Ampicillin-Sulbactam 3g every 4 hour as iv infusion over 1 hour and Meropenem 2g every 8 hour as iv infusion over 3 hours for 14 days

Sponsors

Vice Chancellor for Research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Adult patients (18-65 years old) with ventilator-associated pneumonia due to multidrug resistant gram negative organisms will be included. Exclusion criteria: Infection with gram negative organism with meropenem MIC > 8 µg/ml; Infection with gram negative organism with colistin MIC > 2 µg/ml; Patients with an allergy to each of two antibiotic regimens

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Clinical response of pneumonia to treatment regimen. Timepoint: At day 2, day 7, day 17. Method of measurement: Evaluation of fever, blood cells, pulmonary secretions, oxygenation status.;Microbiological response to treatment regimen. Timepoint: At day 2, day 7. Method of measurement: Tracheal secretion culture.;Clinical outcome of patients. Timepoint: day 7, day 14, day 21, day 28. Method of measurement: 28 days patients' follow-up.;Duration of ICU stay. Timepoint: day 7, day 14, day 21, day 28. Method of measurement: 28 days patients' follow-up.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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