Nebulized Colistin for Hospital-Acquired Pneumonia

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Pneumonia

Treatments: Drug: nebulized colistin; Drug: antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT00920270

Siriraj CEU 50-002

Details and patient eligibility

About

Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram Negative Bacteria should be more effective than conventional therapy

Full description

Randomized Controlled Clinical Trial in hospitalized adult patients with hospital-acquired pneumonia. The patients are allocated to conventional group or nebulized colistin group. The conventional group receives conventional antibiotics whereas the nebulized colistin group receives nebulized colistin in addition to conventional antibiotics. The outcomes are clinical response and microbiological responses.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (age>18 years) hospitalized patient with hospital-acquired pneumonia due to Gram negative bacteria

Exclusion criteria

• pregnancy
• lactating woman
• colistin allergy
• severe renal impairment
• epilepsy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

antibiotic

Active Comparator group

Description:

conventional antibiotics

Treatment:

Drug: antibiotics

colistin group

Experimental group

Description:

nebulized colistin

Treatment:

Drug: nebulized colistin