Comparison of the effect of combining high-dose ampicillin-sulbactam with tigecycline or colistin in the treatment of ventilator-associated pneumonia (VAP)

A comparative study of the effect of combining high-dose ampicillin-sulbactam with tigecycline or colistin in the treatment of ventilator-associated pneumonia (VAP) caused by highly drug-resistant Acinetobacter baumannii (XDR-Ab): a randomized and controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251220068393N1

Enrollment

Registered

2025-12-30

Start date

2026-01-21

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Ventilator-associated pneumonia (VAP) caused by extensively drug-resistant Acinetobacter baumannii (XDR-Ab). Pneumonia due to other aerobic Gram-negative bacteria

Interventions

Intervention 1: Intervention group: Intervention group: Ampicillin sulbactam at a dose of 9 grams every 8 hours as a 4-hour intravenous infusion and tigecycline at a dose of 200 mg initially and then

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Mechanical ventilation (intubation) for more than 48 hours Diagnosis of VAP Growth of XDR-Ab in lung culture

Exclusion criteria

Exclusion criteria: Pregnancy Breastfeeding History of allergy to any of the antibiotics colistin, ampicillin, and tigecycline Respiratory distress syndrome Pulmonary tuberculosis Death

Design outcomes

Primary

Measure	Time frame
Clinical response. Timepoint: End of study. Method of measurement: By an infectious disease doctor.	—

Secondary

Measure	Time frame
Change in clinical pulmonary infection score index score. Timepoint: End of treatment. Method of measurement: based on the patient's clinical, radiographic, and microbiological characteristics.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGolnaz Khorasanizadeh

Esfahan University of Medical Sciences

g.khorasanizadeh@resident.mui.ac.ir+98 31 3668 0048

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026