Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors
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|ClinicalTrials.gov Identifier: NCT00752947|
Recruitment Status : Unknown
Verified March 2009 by Beijing Hospital.
Recruitment status was: Recruiting
First Posted : September 16, 2008
Last Update Posted : March 11, 2009
|Condition or disease||Intervention/treatment||Phase|
|Community-Acquired Pneumonia||Drug: moxifloxacin Drug: levofloxacin Drug: metronidazole||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2008|
|Estimated Primary Completion Date :||March 2010|
|Estimated Study Completion Date :||May 2010|
Moxifloxacin 400mg iv. OD followed by moxifloxacin 400mg OD orally, 2-4 weeks.
Other Name: Avelox
|Active Comparator: B||
Levofloxacin 400mg i.v. OD followed by oral levofloxacin 400mg OD, 2-4 weeks
metronidazole 0.5g i.v. bid followed by oral metronidazole 0.2g tid, 2-4 weeks
- Clinical response [ Time Frame: Test-of-cure visit (7-14 days after the end of treatment) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752947
|Contact: Tieying Sunfirstname.lastname@example.org|
|Xiuhong Nie||Not yet recruiting|
|Principal Investigator:||Tieying Sun||Beijing Hospital|