Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Bronchitis

Treatments: Drug: Inhaled colistin

Study type: Interventional

Funder types: Other

Identifiers

NCT02619786

512-2558-EC4

Details and patient eligibility

About

The purpose of this study is to determine whether inhaled colistin is effective in the treatment of ventilator associated tracheobronchitis due to gram negative organism susceptible to colistin.

Full description

Patients diagnosed ventilator-associated tracheobronchitis due to gram negative organism are included to the study.The patients will be received colistin inhalation 75 mg every 12 hours at least 5 days.

The primary objective is to evaluate clinical outcome of inhaled colistin. The secondary objectives are microbiological clearance and toxicity of inhaled colistin.

The sample size was estimated to 62 patients.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of ventilator-associated tracheobronchitis caused by gram negative organism.
• Expected to survive more than 48 hours after enrollment.
• Received intravenous colistin not more than 48 hours prior enrollment.

Exclusion criteria

• Pregnancy and Lactation
• Allergy to colistin
• Serum creatinine > 4 mg/dl or GFR decreased more than 75% from baseline

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

inhaled colistin

Experimental group

Description:

Inhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days

Treatment:

Drug: Inhaled colistin