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Efficacy of regimens with and without meropenem in Acinetobacter infection

Comparison of response to treatment and outcome between triple therapy (colistin + meropenem + ampicillin-sulbactam) and dual therapy (colistin + ampicillin-sulbactam) in patients with carbapenem-resistant Acinetobacter infection admitted to ICU; A randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240117060720N1
Enrollment
46
Registered
2024-06-27
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Condition 1: Sepsis due to Acinetobacter. Condition 2: Pneumonia caused by Acinetobacter. Sepsis due to Acinetobacter baumannii Pneumonia due to Acinetobacter baumannii

Interventions

Intervention 1: Intervention group A: Colistin: 9 million units of loading dose and then 4.5 million units every 12 hours along with adjust according to the patients GFR + meropenem: 2 grams (as an in

Sponsors

Gonabad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Consent of the patient (in case of unconsciousness, his/her companion) to conduct the study ICU admission Probable or definite infection with ventilator-associated pneumonia or hospital-acquired pneumonia or urosepsis or blood infection of any origin Age 18 years or above Report of Acinetobacter in the culture from the site of infection Acinetobacter resistance to carbapenem

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Clinical success after 14 days from the start of treatment. Timepoint: 14 days after the start of treatment. Method of measurement: The success of the treatment is defined by the presence of all the following criteria: • Alive patient • Stable hemodynamics (systolic blood pressure above 90 mmHg without the need for vasopressors) • Improvement or stability of the SOFA score (in patients whose initial SOFA score is equal to or greater than 3 be: an improvement of at least 30% of the score. In patients whose initial SOFA score is less than 3: reduction or stability of the score)• In patients with bacteremia: no growth of isolates on the 14th day.

Secondary

MeasureTime frame
All-cause mortality after 14 days. Timepoint: 14 days after the start of treatment. Method of measurement: Checking whether the patient is dead or alive on the 14th day.;All-cause mortality after 28 days. Timepoint: 28 days after the start of treatment. Method of measurement: Checking whether the patient is dead or alive on the 28th day (If the patient is discharged, his/her status will be checked by phone call).;Microbiological failure. Timepoint: 7 days after the start of treatment. Method of measurement: Isolation of the same bacteria as the initial isolate in the culture performed after 7 days from the start of treatment.;Duration of fever. Timepoint: Daily. Method of measurement: It is measured daily using an axillary thermometer.;Length of stay in ICU. Timepoint: Daily. Method of measurement: Calculation the length of time the patient is in the ICU (for non-deceased patients).;Length of stay in hospital. Timepoint: Daily. Method of measurement: Calculation of the number of days the patient is in the hospital (for non-deceased patients).;Adverse events. Timepoint: Daily. Method of measurement: Clinical evaluation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMostafa Mansouri

Gonabad University of Medical Sciences

mmansourimostafa90@gmail.com+98 51 5722 3028

Outcome results

None listed

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