EUCTR2018-004704-19-GR进行中（未招募）1 期
A Phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co.,Inc0 个研究点目标入组 40 人开始时间: 2020年1月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Has a diagnosis of proven or suspected NP (including HABP or VABP), as determined by the investigator.
- •Note: The diagnosis of NP does not require a pathogen to be isolated from a diagnostic test.
- •2. Is hospitalized and anticipated to receive a minimum of 8 days of concomitant standard-of-care antibiotic therapy for proven or suspected NP. The concomitant standard-of-care antibiotic therapy can have coverage for either gram positive and/or gram-negative respiratory pathogen(s).
- •Note: Concomitant SOC antibiotics may be stopped before the 8-day minimum at the discretion of the investigator. Participants who discontinue or complete concomitant SOC antibiotic therapy in less than 8 days may also discontinue ceftolozane/tazobactam prior to the minimum duration of 8 days at the investigator’s discretion. However, participants are strongly encouraged to receive a minimum of 8 days of ceftolozane/tazobactam.
- •Demographics:
- •3. Is male or female (not pregnant or nursing) from birth (defined as >32 weeks gestational age and =7 days postnatal) to <18 years of age inclusive, at the time of signing the informed consent/assent.
- •Male Participants:
- •Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Male participants are eligible to participate if they agree to the following during the intervention period and for at least 30 days after the last dose of study intervention:
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- •Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause ) as detailed below:
- •- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
- •Female Participants:
- •Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •- Is not a WOCBP
- •- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least [30 days] after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
- •- A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within [48 hours] before the first dose of study intervention.
- •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Informed Consent/Assent:
- •4. The participant (or legally acceptable representative if applicable) provides written informed consent/as
排除标准
- •Medical Conditions:
- •1. Has a documented history of any moderate or severe hypersensitivity (or allergic) reaction to any ß-lactam antibacterial.
- •Note: A history of a rash while on a ß-lactam antibiotic does not automatically exclude a participant (eg, a participant with history of a mild rash followed by uneventful re-exposure may be considered for enrollment).
- •2. For Groups 1-4, has moderate to severe impairment of renal function, defined as an estimated (CrCL) <50 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration.
- •For Group 5, has CrCL <20 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration.
- •Prior/Concomitant Therapy
- •3. Is receiving or is anticipated to receive piperacillin/tazobactam while receiving ceftolozane/tazobactam or has received piperacillin/tazobactam within 24 hours prior to the first dose of ceftolozane/tazobactam.
- •Prior/Concurrent Clinical Study Experience
- •4. Participation in any clinical study of a therapeutic investigational product within 30 days prior to the first dose of ceftolozane/tazobactam.
- •5.Previous participation in any study of ceftolozane or ceftolozane/tazobactam.
- •Diagnostic Assessments:
- •Not applicable.
- •Other Exclusions:
- •6. Has one or more of the following laboratory abnormalities in a specimen obtained at screening:
- •Absolute neutrophil count (ANC) <1000/mm3
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =3 × the upper limit of normal (ULN)
- •Total bilirubin =2 × the ULN (if 7 to =28 days of age and breastfeeding, total bilirubin >10 mg/dL OR =2 × ULN).
- •7. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of study data.
- •8. Has any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure or septic shock.
- •9. Has active immunosuppression, including any of the following:
- •human immunodeficiency virus (HIV) infection, with a known CD4 percentage of <15% in pediatric participants =5 years of age, or CD4 count of <200 cells/mm3 in pediatric participants >5 years of age
- •active hematological malignancy
- •recipient of solid organ or bone marrow transplants
- •currently on immunosuppressive therapy, including cancer chemotherapy currently on medications for prevention of transplant rejection
- •chronic administration of systemic corticosteroids (defined as the systemic equivalent of =2 mg/kg total daily dose of prednisone for participants =20 kg, or >40 mg of prednisone per day for participants >20 kg, administered continuously for more than 14 days in the 30 days prior to the first dose of
- •ceftolozane/tazobactam)
- •10. Is or has an immediate family member (eg, parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.
研究者
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