Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors
Information source: Beijing Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Community-Acquired Pneumonia
Intervention: moxifloxacin (Drug); levofloxacin (Drug); metronidazole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Beijing Hospital Official(s) and/or principal investigator(s):
Tieying Sun, Principal Investigator, Affiliation: Beijing Hospital
Overall contact:
Tieying Sun, Phone: 86-10-13701034257, Email: suntieying3@hotmail.com
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical response
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Tieying Sun, Phone: 86-10-13701034257, Email: suntieying3@hotmail.com
Xiuhong Nie, Beijing, China; Not yet recruiting
Tieying Sun, Beijing, China; Recruiting
Additional Information
Starting date: September 2008
Ending date: May 2010
Last updated: March 10, 2009
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