- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00044486
Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899)
A Randomized Controlled Trial of Posaconazole (SCH 56592) vs. Standard Azole Therapy for the Prevention of Invasive Fungal Infections Among High-Risk Neutropenic Patients
This trial is in high risk patients to determine the safety and efficacy of posaconazole vs. fluconazole in the prophylaxis against development of invasive fungal infections.
Profound, prolonged neutropenia (Absolute neutrophil count<500 cells/cubic mm for at least 7 days) due to induction chemotherapy for acute myelogenous leukemia, or myelodysplastic syndrome.
Treatment Duration: maximum of 12 weeks Follow-Up 2 months. Endpoints: incidence of proven or probable IFI according to EORTC/MSG criteria within the neutropenic episode and within 100 days of randomization as determined by external expert review.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 3단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults or adolescents (age>13 years) and weight> 34kg, either gender
- Disease definition: Anticipated or documented prolonged neutropenia (ANC<500/mm3 2) Eastern Cooperative Oncology Group (ECOG) performance score of less than 3.
- Female subjects of childbearing age must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation).
- Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hcG) at Baseline or within 72 hours before the start of the study drug.
Exclusion Criteria:
- Female subjects who are pregnant, intend to become pregnant, or are nursing.
- Excluded prior treatments: Subjects previously treated with AMB, FLZ, or ITZ for proven or probable IFI within 30 days of enrollment.
- Excluded treatments prior to specific study phases: Subjects who have taken the following drugs: those known to interact with azoles and that may lead to life-threatening side effects.
- Subjects who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.
- Subjects who are participating in any other blinded clinical study within 30 days of study entry.
- Subjects with renal insufficiency (estimated creatinine clearance less than 20 mL/minute at Baseline or likely to require dialysis during the study).
- Subjects having an ECG with a prolonged QTc interval by manual reading: QTc greater than 450 msec for men and greater than 470 msec for women.
- Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase levels greater than 5 times the upper limit of normal (ULN), or a total bilirubin level greater than 3 times the ULN.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P01899
개별 참가자 데이터(IPD) 계획
연구 데이터/문서
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. .
포사코나졸 경구 현탁액에 대한 임상 시험
-
Sunnybrook Health Sciences Centre완전한
-
Federal University of the Valleys of Jequitinhonha...완전한
-
The Methodist Hospital Research Institute알려지지 않은
-
Biomedical Development CorporationNational Heart, Lung, and Blood Institute (NHLBI); University of Kentucky알려지지 않은