Efficacy and Safety of Colistin for Therapy of Infections Caused by ESBL Producing K.Pneumoniae or E.Coli

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Infections

Treatments: Drug: Colistin

Study type: Interventional

Funder types: Other

Identifiers

NCT00300560

SirirajCEU49-004

Details and patient eligibility

About

In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.

Full description

In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.The primary outcome is clinical response and secondary outcomes are microbiological response and adverse events.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 yr.
• Hospitalized to Siriraj Hospital
• Infections with ESBL-producing E.coli or K.pneumoniae
• Consent informed consent

Exclusion criteria

• Pregnancy or lactating mother
• Colistin allergy
• Neurologic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)