NCT00458900

Brief Summary

In the Intensive Care (IC)-unit moxifloxacin treatment is often started with intravenous administrations. As moxifloxacin is known to have a high oral bioavailability in healthy volunteers, patients are switched to oral or enteral therapy as soon as possible. However, no data on plasma levels for moxifloxacin during such a switch-therapy in IC-patients are available. Therefore, this study aims to evaluate the moxifloxacin-plasma levels and their inter-individual variability during IV to enteral switch therapy in IC-patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 10, 2012

Status Verified

December 1, 2012

Enrollment Period

5.2 years

First QC Date

April 10, 2007

Last Update Submit

December 7, 2012

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    Pharmacokinetics will be followed.

    2 days

Study Arms (1)

IV and enteral administration of moxifloxacin

EXPERIMENTAL

IV and enteral administration of moxifloxacin

Drug: IV and enteral administration of moxifloxacin

Interventions

IV and enteral administration of moxifloxacinDRUG

IV and enteral administration of moxifloxacin

IV and enteral administration of moxifloxacin

Eligibility Criteria

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

You may qualify if:

  • IC patients treated with 400 mg moxifloxacin IV (once a day) that can be switched to enteral administration of 400 mg moxifloxacin.
  • IV steady state
  • Hemodynamic stability
  • Normal enteral feeding without prokinetics
  • Presence of arterial line
  • Informed consent
  • ≥ 18 jaar

You may not qualify if:

  • Dialysis patients
  • Creatinine clearance \< 30 ml/min
  • Transaminase levels \> 5x upper limit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Kirsten Colpaert, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 11, 2007

Study Start

July 1, 2007

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 10, 2012

Record last verified: 2012-12

Locations

BE(1)