NCT00920270

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
140

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

June 15, 2009

Status Verified

June 1, 2006

Enrollment Period

3.8 years

First QC Date

June 11, 2009

Last Update Submit

June 11, 2009

Conditions

Pneumonia

Keywords

Hospital-Acquired PneumoniaGram Negative Bacteria

Outcome Measures

Primary Outcomes (1)

  • Clinical response

    14 days after Treatment

Secondary Outcomes (1)

  • Microbiological response and safety

    14 days after treatment

Study Arms (2)

antibiotic

ACTIVE COMPARATOR

conventional antibiotics

Drug: antibiotics

colistin group

EXPERIMENTAL

nebulized colistin

Drug: nebulized colistin

Interventions

nebulized colistinDRUG

nebulized colistin 75 mg every 12 hours

colistin group
antibioticsDRUG

conventional parenteral antibiotics

antibiotic

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

PneumoniaHealthcare-Associated Pneumonia

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesCross InfectionIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Visanu Thamlikitkul, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

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

June 11, 2009

First Posted

June 15, 2009

Study Start

June 1, 2006

Primary Completion

March 1, 2010

Last Updated

June 15, 2009

Record last verified: 2006-06

Locations

TH(1)