CTRI/2023/06/053835招募中2 期
A phase 2A multicenter, observer-blinded, randomized 2 arm Study to investigate pharmacokinetics, safety, tolerability and efficacy of intravenous Aztreonam-Avibactam ± Metronidazole compared to Best Available Therapy (BAT) in pediatric participants 9 months to less than 18 years of age with serious gram-negative bacterial Infections including complicated intra-abdominal Infection
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Pfizer Inc
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Age and Sex:
- •1. Participants =9 months to <18 years of age at Screening
- •a) Refer below for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. Female (post-pubertal) participants must have a negative serum/urine pregnancy test (ß-hCG sensitivity =25 mIU/mL),
- •Disease Characteristics:
- •2. Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative
- •3. Require hospitalization and IV antibiotic treatment.
- •Male Participant Reproductive Inclusion Criteria:
- •Male participants are eligible to participate if they agree to the following requirements
- •during the intervention period and for at least 7 days after the last dose of study intervention, which corresponds to the time needed to eliminate reproductive safety risk of the study intervention(s):
- •1. Refrain from donating sperm.
- •PLUS either:
- •2. Be abstinent from heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
- •3) Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
- •Female Participant Reproductive Inclusion Criteria:
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and
- •at least 1 of the following conditions applies:
- •1) Is not a WOCBP (Woman of Childbearing Potential)
- •2) Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), as described below, during the intervention period and for at least 28 days after the last dose of study intervention, which
- •corresponds to the time needed to eliminate any reproductive safety risk of the study intervention(s). If a highly effective method that is user dependent is chosen, a second effective method of contraception, as described below, must
- •also be used. The investigator should evaluate the effectiveness of the contraceptive method in relationship to 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.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- •2. Gram-negative species not expected to respond to ATM-AVI =14 days
- •3. Pregnant or breastfeeding; fertile male/female unwilling/unable to use effective contraception for at =7 days (males) or =28 days (females) after last ATM-AVI infusion.
- •HAP/VAP only
- •4. Microbiologically known or high likelihood of monomicrobial infection with a gram-positive organism, lung abscess, pleural empyema, or post-obstructive pneumonia, lung or heart transplant.
- •5. Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s).
- •Prior and Concomitant Therapy.
- •6. Received >24 hours of systemic antibiotics (abx) for =48hr before randomization,
- •a. Failed systemic abx for >48hr.
- •b. Not taking protocol prohibited medications,
- •Prior/Concurrent Clinical Study Experience:
- •Previous administration with an investigational product (drug or vaccine) within 30 days(or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).Diagnostic Assessments:
- •7. CrCL =15 mL/min/1.73 m2 (eGFR calculation based on age).
- •8. Non-infectious related screening ALT or AST >3 x ULN, ALP >3 x ULN and/orTBili >2 x ULN ( > 3 x ULN for Gilbert’s syndrome),
- •Other Exclusions:
- •9. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
研究者
相似试验
进行中（未招募）
1 期
Study to evaluate immunogenicity and safety of GSK Biologicals’ measles, mumps, rubella and varicella (MMRV) freezer-stored (MMRVF) & refrigerator-stored (MMRVR) vaccine formulations vs. ProQuad in infants 12-14 months of age when co-administered with hepatitis A and pneumococcal conjugate vaccines.Healthy volunteers (Use of the candidate MMRV vaccine for immunization of healthy children 12 - 14 months of age against measles, mumps, rubella and varicella).EUCTR2017-000454-18-Outside-EU/EEAGlaxoSmithKline Biologicals1,851
进行中（未招募）
不适用
A phase II, randomized, multicentre, observer-blind study to compare and characterize the immunoginicity and safety parameters induced by various GSK Biologicals’ Adjuvant Systems in combination with the Hepatitis B surface antigen (HBsAg), according to a 0, 1 month schedule with a booster at Month 12, in healthy, Hepatitis B virus (HBV) naïve, adults. - EARLY-CLINRES-002EUCTR2008-004455-29-BEGlaxoSmithKline Biologicals710
进行中（未招募）
不适用
A phase II, randomized, multicentre, observer-blind study to compare and characterize the immunoginicity and safety parameters induced by various GSK Biologicals’ Adjuvant Systems in combination with the Hepatitis B surface antigen (HBsAg), according to a 0, 1 month schedule with a booster at Month 12, in healthy, Hepatitis B virus (HBV) naïve, adults. - EARLY-CLINRES-002Hepatitis B surface antigen (HBsAg) vaccine administred in HBV naïve adult subjects aged between 18 and 45 years old, inclusive, in good general health.EUCTR2008-004455-29-DEGlaxoSmithKline Biologicals710
进行中（未招募）
1 期
Study of the immune system responses and side effects in children of different dosing levels of a flu vaccine for use in a pandemic situation.EUCTR2016-001898-32-Outside-EU/EEASeqirus UK Limited
进行中（未招募）
1 期
Study of the immune system responses and side effects in children of different dosing levels of a flu vaccine for use in a pandemic situation.Prophylaxis for Influenza virusMedDRA version: 20.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsEUCTR2016-001898-32-EESeqirus UK Limited420