Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors
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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
-
-
-
Beijing, 중국
- 모병
- Tieying Sun
-
Beijing, 중국
- 아직 모집하지 않음
- Xiuhong Nie
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 비
|
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
|
|
실험적: ㅏ
|
Moxifloxacin 400mg iv.
OD followed by moxifloxacin 400mg OD orally, 2-4 weeks.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Clinical response
기간: Test-of-cure visit (7-14 days after the end of treatment)
|
Test-of-cure visit (7-14 days after the end of treatment)
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Tieying Sun, Beijing Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MOHBJH-STY-1
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
moxifloxacin에 대한 임상 시험
-
Richmond Pharmacology Limited완전한다른 식사가 QT/QTc 간격에 미치는 영향 | 치료 사용 시 부작용을 일으키는 인슐린 및 경구용 혈당강하제[항당뇨병] 약물 | QT/QTc 간격에 대한 C-펩티드 효과 | Fed 및 Fasted 상태의 Moxifloxacin ECG 프로필 | 일본인 대 백인 TQT 비교영국
-
Facultad Nacional de Salud PublicaUniversidad de Antioquia완전한