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Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors

Primary Purpose

Community-Acquired Pneumonia

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

moxifloxacin

levofloxacin

metronidazole

About this trial

This is an interventional treatment trial for Community-Acquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.
Previous history of tendinopathy with quinolones.
Patients who have previously been included in this study.
Patients with any investigational drug within 30 days of screening.
Patients requiring concomitant systemic antibacterial agents.
Pre-treatment with a systemic antibacterial agent within 24 hours prior to enrollment (Except for the cases that pre-treatment is not effective based on the clinical judgment).
Severe CAP.
Other contraindications in package insert.

Sites / Locations

Tieying SunRecruiting
Xiuhong Nie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Clinical response

Secondary Outcome Measures

Full Information

NCT ID

NCT00752947

First Posted

September 15, 2008

Last Updated

March 10, 2009

Sponsor

Beijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00752947

Brief Title

Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors

Official Title

Multi-Centre, Prospective, Open Label, Randomized Trial to Assess the Efficacy and Safety of Moxifloxacin Versus Levofloxacin Plus Metronidazole in the Treatment of Community-Acquired Pneumonia With Aspiration Factors

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

March 2010 (Anticipated)

Study Completion Date

May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Beijing Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

186 patients in 4 centers will be enrolled in this study. Patients accord with the criteria of CAP with aspiration factors will be enrolled and randomized to one of the following groups. The treatment duration will range from 2 to 4 weeks. Study Group: Intravenous treatment with moxifloxacin 400mg i.v. OD. Based on investigator's decision, a switch can be made to moxifloxacin 400 mg OD, orally (Moxifloxacin injection will be used no more than 3 weeks consecutively) . Control Group: Intravenous treatment with levofloxacin 400mg i.v. OD plus metronidazole 0.5g i.v. bid. Based on investigator's decision, a switch can be made to levofloxacin 400mg OD plus metronidazole 0.2g tid, orally. Treatment should be continued until complete resolution of the radiological, clinical and laboratory alterations or until no further regression can be observed. Clinical, bacteriological, laboratory and radiological examinations will be performed pre-treatment. Swallowing/coughing reflection test will be used for aspiration factor diagnosis. Risk factors (Decreased level of consciousness, dysphagia, gastroesophageal reflux, neurologic disease, mechanical and device-related (e.g. nasogastric feeding tube) impairment of upper aerodigestive tract, vomiting, bronchial obstruction due to neoplasm or foreign body, bronchiectasis, pulmonary infarction, etc) will be evaluated before the treatment. Clinical and laboratory examinations such as blood routine(including Hb, differential blood count, etc), urine routine, biochemistry examination (including serum bilirubin, hepatic/renal function parameters, etc), coagulation examination will be repeated selectively. Radiological examination (e.g. chest x-ray) will be repeated at each visit for clinical monitoring after one week treatment. At the test-of-cure visit (7-14 days after the end of therapy) comprehensive clinical, bacteriological and laboratory examinations will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Community-Acquired Pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

moxifloxacin

Other Intervention Name(s)

Avelox

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

levofloxacin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

metronidazole

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical response

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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. Previous history of tendinopathy with quinolones. Patients who have previously been included in this study. Patients with any investigational drug within 30 days of screening. Patients requiring concomitant systemic antibacterial agents. Pre-treatment with a systemic antibacterial agent within 24 hours prior to enrollment (Except for the cases that pre-treatment is not effective based on the clinical judgment). Severe CAP. Other contraindications in package insert.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tieying Sun

Phone

86-10-13701034257

suntieying3@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tieying Sun

Organizational Affiliation

Beijing Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tieying Sun

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Name

Xiuhong Nie

City

Beijing

Country

China

Individual Site Status

Not yet recruiting

12. IPD Sharing Statement

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Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors

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