Ignite Creation Date:
2024-05-05 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00752947
Status:
UNKNOWN
Last Update Posted:
2009-03-11
First Post:
2008-09-15
Brief Title:
Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia CAP With Aspiration Factors
Sponsor:
Beijing Hospital
Organization:
Beijing Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 iv OD Based on investigators 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 iv OD plus metronidazole 05g iv bid Based on investigators decision a switch can be made to levofloxacin 400mg OD plus metronidazole 02g 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 Swallowingcoughing reflection test will be used for aspiration factor diagnosis Risk factors Decreased level of consciousness dysphagia gastroesophageal reflux neurologic disease mechanical and device-related eg 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 routineincluding Hb differential blood count etc urine routine biochemistry examination including serum bilirubin hepaticrenal function parameters etc coagulation examination will be repeated selectively Radiological examination eg 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 Group Intravenous treatment with moxifloxacin 400mg iv OD Based on investigators 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 iv OD plus metronidazole 05g iv bid Based on investigators decision a switch can be made to levofloxacin 400mg OD plus metronidazole 02g 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 Swallowingcoughing reflection test will be used for aspiration factor diagnosis Risk factors Decreased level of consciousness dysphagia gastroesophageal reflux neurologic disease mechanical and device-related eg 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 routineincluding Hb differential blood count etc urine routine biochemistry examination including serum bilirubin hepaticrenal function parameters etc coagulation examination will be repeated selectively Radiological examination eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None