Community-Acquired Pneumonia Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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