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

Sponsored by:	Beijing Hospital
Information provided by:	Beijing Hospital
ClinicalTrials.gov Identifier:	NCT00752947

Purpose

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.

Condition	Intervention	Phase
Community-Acquired Pneumonia	Drug: moxifloxacin Drug: levofloxacin Drug: metronidazole	Phase IV

MedlinePlus related topics: Pneumonia

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Ofloxacin Levofloxacin Ofloxacin hydrochloride Moxifloxacin Moxifloxacin hydrochloride Metronidazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Beijing Hospital:

Primary Outcome Measures:

Clinical response [ Time Frame: Test-of-cure visit (7-14 days after the end of treatment) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	186
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: moxifloxacin Moxifloxacin 400mg iv. OD followed by moxifloxacin 400mg OD orally, 2-4 weeks.
B: Active Comparator	Drug: levofloxacin Levofloxacin 400mg i.v. OD followed by oral levofloxacin 400mg OD, 2-4 weeks Drug: metronidazole metronidazole 0.5g i.v. bid followed by oral metronidazole 0.2g tid, 2-4 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752947

Contacts

Contact: Tieying Sun

86-10-13701034257

suntieying3@hotmail.com

Locations

China
Xiuhong Nie	Not yet recruiting
Beijing, China
Tieying Sun	Recruiting
Beijing, China

Sponsors and Collaborators

Beijing Hospital

Investigators

Principal Investigator:

Tieying Sun

Beijing Hospital

More Information

No publications provided

Responsible Party:	Beijing Hospital ( Prof. Sun Tieying )
Study ID Numbers:	MOHBJH-STY-1
Study First Received:	September 15, 2008
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00752947 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Anti-Bacterial Agents
Metronidazole
Radiation-Sensitizing Agents
Respiratory Tract Infections
Respiratory Tract Diseases

Moxifloxacin
Lung Diseases
Ofloxacin
Anti-Infective Agents, Urinary
Pneumonia

Additional relevant MeSH terms:

Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Ofloxacin
Physiological Effects of Drugs
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Pharmacologic Actions

Anti-Bacterial Agents
Antiparasitic Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Radiation-Sensitizing Agents
Moxifloxacin
Lung Diseases
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors
Pneumonia

ClinicalTrials.gov processed this record on May 07, 2009