NCT00752947

Brief Summary

The purpose of this study is to determine whether moxifloxacin in comparison to levofloxacin plus metronidazole are effective and safe in the treatment of community-acquired pneumonia with aspiration factors.

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
186

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

2 active sites

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

September 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

March 11, 2009

Status Verified

March 1, 2009

Enrollment Period

1.5 years

First QC Date

September 15, 2008

Last Update Submit

March 10, 2009

Conditions

Community-Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Clinical response

    Test-of-cure visit (7-14 days after the end of treatment)

Study Arms (2)

A

EXPERIMENTAL
Drug: moxifloxacin

B

ACTIVE COMPARATOR
Drug: levofloxacinDrug: metronidazole

Interventions

moxifloxacinDRUG

Moxifloxacin 400mg iv. OD followed by moxifloxacin 400mg OD orally, 2-4 weeks.

Also known as: Avelox
A
levofloxacinDRUG

Levofloxacin 400mg i.v. OD followed by oral levofloxacin 400mg OD, 2-4 weeks

B
metronidazoleDRUG

metronidazole 0.5g i.v. bid followed by oral metronidazole 0.2g tid, 2-4 weeks

B

Eligibility Criteria

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

You may qualify if:

  • Male or female patients aged 18 years or above.
  • Patients who are willing and able to provide written informed consent.
  • Accord with the diagnosis criteria of CAP based on clinical, radiological and microbiological findings.
  • With aspiration factors (Including swallowing or coughing reflection test positive)

You may not qualify if:

  • Known hypersensitivity to fluoroquinolones and/or metronidazole.
  • Female patients who are pregnant or lactating.
  • Patients with mechanical ventilation lasting more than 48 hours prior to enrollment.
  • Patients with neutropenia (neutrophil count \<1.000/mm3) due to malignancy or chemotherapy.
  • Patients with a severe, life-threatening disease with a life expectancy of less than 2 months.
  • Patients with a co-existent disease considered likely to affect the outcome of the study (e.g. lung cancer, cystic fibrosis, collagen vascular disease affecting the lungs, pleural empyema, severe cardiac failure class III or IV of the NYHA).
  • Patients with poststenotic pneumonia (e.g. in connection with carcinoma of the lung).
  • Patients with acute infarction pneumonia.
  • Patients with active pulmonary tuberculosis.
  • Patients with lung abscess/pneumonia with concomitant endocarditis.
  • Patients with known i.v. drug abuse.
  • Patients known to have AIDS (CD4 count \<200/ul) or HIV-seropositives who are receiving HAART (highly activated antiretroviral therapy). Note: HIV-positive patients may be included. HIV testing is not required for this study protocol.
  • Patients with severe hepatic impairment (Child-Pugh C).
  • Patients on hemodialysis, equivalent to creatinine clearance \<15 ml/min/1.73 m2.
  • Patients known to have congenital or sporadic syndromes of QTc prolongation, or are receiving concomitant medication reported to increase the QTc interval, e.g. amiodaron, sotalol, disopyramide, quinidine, procainamide, terfenadine.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tieying Sun

Beijing, China

RECRUITING

Xiuhong Nie

Beijing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

MoxifloxacinLevofloxacinMetronidazole

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsOfloxacinNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Tieying Sun

    Beijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tieying Sun

CONTACT

86-10-13701034257suntieying3@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 16, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

March 11, 2009

Record last verified: 2009-03

Locations

CN(2)