The clinical and bacteriological efficacy of Doripenem (DRPM) in patients with infections by Extended-spectrum beta-lactamase (ESBLs)-producing strains: non-randomized, open, label, multi-centre study.

The clinical and bacteriological efficacy of Doripenem (DRPM) in patients with infections by Extended-spectrum beta-lactamase (ESBLs)-producing strains: non-randomized, open, label, multi-centre study. - The clinical and bacteriological efficacy of DRPM in patients with infections by ESBL-producing strains.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000010722

Enrollment

200

Registered

2013-05-14

Start date

2012-02-16

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

Adaptable infections of DRPM

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients or guardian of the patients with informed consent. 2) Age: over 16 years (at the time the informed consent form is signed). 3) Gender: Male or female 4) In patients. 5) Adaptable infections of DRPM. 6) Patients of the following criteria (a) or (b) at the time the informed consent form is signed: (a) The possibility of infection by ESBL-producing strains because of past episodes etc,. (b) The proving of ifections by ESBL-producing strains because of drug sensitivity test etc,.

Exclusion criteria

Exclusion criteria: 1) Hisotry of spilepsy. Neurological symptoms with convulsions. 2) History of hypersensitivity, allergy or serious adverse drug event caused by beta-lactam antibiotics. 3) Woman who are pregnant and breast-feeding or suspected to be pregnant. 4) Any other patients whose condition is inappropriate for the evaluation of this clinical study as judged by the investigator.

Design outcomes

Primary

Measure	Time frame
Clinical efficacy in patients with infections by ESBL-producing strains at the end of medication.	—

Secondary

Measure	Time frame
Clinical efficacy in patients with infections by ESBL-producing strains at 7 days of medication. Bacteriological efficacy in ESBL-producing strains at the end of medication. And a comparison between above ESBL and non-ESBL (include patients without isolates pathogenic strains).	—

Countries

Japan

Contacts

Public ContactYuka Yamagishi

Aichi Medical University Hospital Department of Clinical Infectious Diseases

0561-62-3311

Outcome results