NCT00300560

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 22, 2006

Status Verified

March 1, 2006

First QC Date

March 7, 2006

Last Update Submit

May 19, 2006

Conditions

Infections

Keywords

ESBL-producing E.coli InfectionsESBL-producing Klebsiella pneumoniae InfectionsColistin

Outcome Measures

Primary Outcomes (1)

  • Clinical response

Secondary Outcomes (1)

  • Microbiological response

Interventions

ColistinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy or lactating mother
  • Colistin allergy
  • Neurologic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Colistin

Intervention Hierarchy (Ancestors)

PolymyxinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteins

Study Officials

  • Visanu Thamlikitkul, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Visanu Thamlikitkul, MD

CONTACT

662 419 7000sivth@mahidol.ac.th

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 9, 2006

Study Start

February 1, 2006

Study Completion

December 1, 2006

Last Updated

May 22, 2006

Record last verified: 2006-03

Locations

TH(1)