PER-005-19尚未招募未知
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED STUDYTO COMPARE THE EFFICACY AND SAFETY OF RIDINILAZOLE (200 MG,BID) FOR 10 DAYS WITH VANCOMYCIN (125 MG, QID) FOR 10 DAYS INTHE TREATMENT OF CLOSTRIDIUM DIFFICILE INFECTION (CDI).
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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
- •Inclusion Criteria Patients are eligible to be included in the study only if all
- •the following criteria apply: Age 1. Patient must be at least 18 years of age,
- •at the time of signing the informed consent. Type of Patient and Disease
- •Characteristics 2. Have signs and symptoms of CDI including diarrhea such
- •that in the Investigator’s opinion CDI antimicrobial therapy is required.
- •Diarrhea is defined as a change in bowel habits, with ≥3 UBMs (5, 6 or 7 on
- •the Bristol Stool Chart) in the 24 h prior to randomization. 3. Have the
- •presence of either toxin A and/or B of C. difficile in the stool determined by
- •a positive free toxin test (using a Sponsor agreed test). The stool sample
- •must have been produced within 72 hours prior to randomization. Sex 4.
- •Male or Female Male patients: • A male patient must agree to use
- •contraception as detailed in Appendix 4 of this protocol during the
- •treatment period and for at least 30 days after the last dose of study
- •treatment and refrain from donating sperm during this period. Female
- •patients: • A female patient is eligible to participate if she is not pregnant
- •(see Appendix 4), not breastfeeding, and at least one of the following
- •conditions applies: i. Not a woman of childbearing potential (WOCBP) as
- •defined in Appendix 4 OR ii. A WOCBP who agrees to follow the
- •contraceptive guidance in Appendix 4 during the treatment period and for at
- •least 30 days after the last dose of study treatment. Informed Consent 5.
- •Has provided documented signed informed consent and any authorizations
- •required by local law (e.g. Protected Health Information [PHI]).
排除标准
- •Exclusion Criteria Patients are excluded from the study if any of the
- •following criteria apply: Medical Conditions 1. Have had more than one prior
- •episode of CDI in the previous 3 months or more than 3 episodes in the
- •past 12 months 2. Have a history of chronic diarrheal disease including
- •inflammatory bowel disease (Crohn’s disease or ulcerative colitis). 3. Have
- •had a positive diagnostic test for other GI pathogens, considered to be
- •clinically relevant, within 2 weeks of randomization. 4. Have had major
- •gastrointestinal (GI) surgery (e.g. significant bowel resection) within 3
- •months of randomization (this does not include appendectomy). The
- •presence of a colostomy or ileostomy or likely requirement of an ostomy
- •during the study. 5. Have life threatening or fulminant CDI with evidence of
- •hypotension, septic shock, peritoneal signs or absence of bowel sounds, or
- •toxic megacolon. 6. Have a known current history of significantly
- •compromised immune system e.g. a. HIV positive with a CD4<200
- •cells/mm3 within 6 months of randomization. b. Severe neutropenia with
- •neutrophil count < 500 cells/mL. c. Are on concurrent immunosuppressive
- •therapy for recent (within previous 6 months) or anticipated solid organ
- •transplant or bone marrow transplant. d. Are on a concurrent
- •chemotherapy, radiotherapy or biologic for active malignancy. Or active
- •malignancy with ablative chemotherapy within the past 3 months or
- •anticipated during the study. Prior/Concomitant Therapy 7. Have had more
- •than 24 hours of dosing, or equivalent (i.e. four doses of oral vancomycin,
- •two doses of fidaxomicin or three doses of metronidazole) of antimicrobial
- •treatment active against the current episode of CDI prior to randomization.
- •8. Prior or current use of anti-toxin antibodies including bezlotoxumab 9.
- •Are unable to discontinue products used to affect bowel movement or
- •disease progression (see Section 6.5.1 for a list of potentially confounding
- •medications). Prior/Concurrent Clinical Study Experience 10. Has been
- •involved in a clinical trial and received an investigational medicinal product
- •for indications other than CDI within 1 month or five half-lives (whichever is
- •longer) or within 3 months if the investigational medical product was for
- •CDI. 11. Have received an investigational vaccine against C. difficile. Other
- •Exclusions 12. Patients that the Investigator feels are inappropriate for the
- •study this would include those; a. with any other condition that, in the
- •Investigator´s judgment, would make the patient unsuitable for inclusion in
- •the study. b. who, in the opinion of the Investigator, are not likely to
- •complete the study for whatever reason. E.g. short life expectancy. c. with
- •known hypersensitivity or intolerance to ridinilazole, vancomycin, and/or
- •their excipients d. who are unwilling or unable to comply with protocol
- •requirements, e.g. complete the full course of study treatment per schedule,
- •attend study visits, complete an electronic diary (or have a caregiver able to
- •complete this on the patient’s behalf), provide stool samples, ingest
- •capsules, blood draws.
研究者
相似试验
已完成
不适用
A STUDY EVALUATING THE EFFICACY, SAFETY, AND TOLERABILITY OF CEFEPIME/VNRX-5133 IN ADULTS WITH COMPLICATED URINARY TRACT INFECTIONS.-N390 Urinary tract infection, site not specifiedUrinary tract infection, site not specifiedN390PER-023-19VenatoRx Pharmaceuticals, Inc. (VenatoRx),21
招募中
不适用
A PHASE III, RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR-CONTROLLED CLINICAL TRIAL TOSTUDY THE SAFETY, TOLERABILITY, AND EFFICACY OF IMIPENEM/CILASTATIN/RELEBACTAM (MK-7655A)VERSUS PIPERACILLIN/TAZOBACTAM IN SUBJECTS WITH HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA ORVENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA-J15J15PER-030-17Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
招募中
不适用
A PHASE III, RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR-CONTROLLED CLINICAL TRIAL TO ESTIMATE THE EFFICACY AND SAFETY OF IMIPENEM/CILASTATIN/RELEBACTAM (MK-7655A) VERSUS COLISTIMETHATE SODIUM + IMIPENEM/CILASTATIN IN SUBJECTS WITH IMIPENEM-RESISTANT BACTERIAL INFECTIO-A488 Other specified bacterial diseasesOther specified bacterial diseasesA488PER-026-15MERCK SHARP & DOHME PERU S.R.L.,1
未知
不适用
A PHASE III, RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR-CONTROLLED CLINICAL TRIAL, CONDUCTED UNDER IN-HOUSE BLINDING CONDITIONS, TO EXAMINE THE EFFICACY AND SAFETY OF APREPITANT FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) IN PEDIATRIC PATIENTSPER-080-11MERCK SHARP & DOHME PERU S.R.L.,10
进行中（未招募）
1 期
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEEEUCTR2012-003721-22-LTPfizer Inc, 235 East 42nd Street, New York, NY 100173,000