NCT00548262已完成4 期
Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole, For Treatment Of Documented Candidemia/Invasive Candidiasis In Hospitalized Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment
研究概览
简要总结
The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient 18 years of age and older.
- •If female, must be post-menopausal, surgically sterile or using adequate contraception,not lactating, and have a negative urine or blood pregnancy test at screening, prior to administration of study medication.
- •Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours to study entry ((informed consent provided).
- •Presence of one or more of the following signs and symptoms of acute fungal infection within the prior 48 hours to initiation of study treatment:
- •Fever defined as oral temperature greater than or equal to 38 degrees C (100.4 degrees F); rectal or core temperature greater than or equal to 38.6 degrees C (101.4 degrees F), or axillary temperature greater than or equal to 37.5 degrees Celsius (99.5 degrees F). Hypothermia defined as rectal or core temperature less than 36.0 degrees C (96.8 degrees F).
- •Hypotension (systolic blood pressure [SBP] less than 100 mmHg, or SBP decrease greater than or equal to 30 mm Hg from baseline.
- •Localized signs and symptoms of inflammation (swelling, heat, erythema or purulence at a site infected with Candida spp.).
- •Patient is classified in one of following categories based on previous antifungal treatment: received less than 48 hours of previous systemic antifungal therapy and no more than a single dose of echinocandin therapy prior to study entry; intolerant to infusion related toxicities of amphotericin B preparations despite appropriate supportive measures or serum creatinine increased by >1.5 mg/dl while receiving conventional or lipid amphotericin B therapy; or lack of clinical response and/or persistent positive blood culture after at least seven days of systemic antifungal treatment with a polyene or fluconazole at an adequate dose.
- •APACHE II 9 score < 25 at study entry.
- •Patients willing and able to give informed consent, or have a legally authorized representative willing to give informed consent on the patients behalf.
- •Expected survival (in the opinion of the investigator) greater than 4 days.
排除标准
- •Hypersensitivity to anidulafungin, other echinocandins or azoles.
- •Participation presently or within the last 30 days in a trial with other investigational drug(s). Patients on antiretroviral or chemotherapy regimens which include an investigational drug may participate provided that there has been no change in their therapy during the past 4 weeks and no change in treatment is anticipated during study participation.
- •Chronic refractory neutropenia defined as absolute neutrophils count <500 cells/mm3 for 28 days prior to the baseline visit.
- •Confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
- •Poor venous access that would preclude IV drug delivery or multiple blood draws.
- •Prosthetic devices at a suspected site of infection unless the device is removed within 24 hours of study entry.
- •Fungal endophthalmitis confirmed by fundoscopy.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration that may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the Patient inappropriate for entry into this trial.
研究组 & 干预措施
1
Experimental
干预措施: Anidulafungin (Drug)
1
Experimental
干预措施: Voriconazole (Drug)
结局指标
主要结局
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment
时间窗: End of Treatment (EOT) (up to Day 42)
Clinical Success (cure=resolution of Candida signs and symptoms \[s/s\] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).
次要结局
- Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up(Baseline, Week 2 Follow-up)
- Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)(End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up)
- Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT(Baseline, EIVT (up to Day 42))
- Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT(Baseline, EOT (up to Day 42))
- Change From Baseline in Vital Signs: Supine Blood Pressure(Baseline to Week 2 Follow-up)
- Change From Baseline in Vital Signs: Supine Heart Rate(Baseline to Week 2 Follow-up)
- Change From Baseline in Vital Signs: Weight(Baseline to Week 2 Follow-up)
- Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT(Baseline, EOT (up to Day 42))
- Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT(EIVT (up to Day 42))
- Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up(Baseline, Week 2 Follow-up (F/U))
- Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score(EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up)
- Number of Participants Per Survival Status (Alive or Dead) on Day 30(Day 30)
- Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis(Baseline to Week 6 Follow-up)
- Time to Negative Blood, Specimen, or Tissue Culture(Baseline to Week 2 Follow-up)
- Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment(Baseline to Day 42)
- Length of Hospital Stay(Baseline to Week 6 Follow-up)
- Length of Stay in Intensive Care Unit (ICU)(Baseline up to Week 6 Follow-up)
- Change From Baseline in Vital Signs: Temperature(Baseline to Week 2 Follow-up)
- Change From Baseline in Vital Signs: Respiration Rate(Baseline to Week 2 Follow-up)
- Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)(Baseline to Week 2 Follow-up)
- Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)(Baseline to Week 2 Follow-up)
研究者
研究点 (1)
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