An evaluation of the efficacy and safety of colistimethate sodium injection in patients with multidrug-resistant Gram-negative bacterial infection - A multicenter, unblinded clinical study -

An evaluation of the efficacy and safety of colistimethate sodium injection in patients with multidrug-resistant Gram-negative bacterial infection - A multicenter, unblinded clinical study - - An evaluation of the efficacy and safety of colistimethate sodium injection in patients with multidrug-resistant Gram-negative bacterial infection - A multicenter, unblinded clinical study -

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008226

Enrollment

100

Registered

2012-07-01

Start date

2012-11-12

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

multidrug-resistant Gram-negative bacterial infection

Interventions

Colistin is given in 2 to 4 divided doses at dose levels of 2.5 to 5 mg/kg (7,500 to 15,000 IU/kg as colistimethate sodium) per day. Daily dose is reduced depending on the severity of renal impairment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient infected with Gram-negative bacteria; - resistant to 3 types of antibiotics (carbapenem, fluoroquinolone and aminoglycoside), - or treatment of those antibiotics is ineffective, - or treatment of those antibiotics is expected to be ineffective. Patient aged 16 years old or older.

Exclusion criteria

Exclusion criteria: Allergy for polymyxin. Woman who is pregnant or has chance to be pregnant or breast-feeding.

Design outcomes

Primary

Measure	Time frame
Clinical response at the end of administration.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026