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Study Procedures & Operational Issues Start-up Meeting March 25, 2010 Kingston, ON CERU Contacts Sponsor Dr. Daren Heyland Cell: 613-484-5573 [email protected] Project Leader Janet Overvelde 613.549.6666 x6241 [email protected] Data Manager Jennifer Korol 613.549.6666 x6051 [email protected] Role of Study Coordinator Regulatory Screening & Randomization Pharmacy Communication Blood Sample Draws Data Collection Monitoring Study Intervention Administration Monitoring & Identifying SAEs Protocol Violation Reporting CANTREAT Teamwork Core Lab Site Investigator •Confirm patient eligibility •LPS Stimulation •Blood Processing •Infection adjudication •SAE Reporting •Shipping to central lab in Ohio, USA Research Coordinator Micro Lab •Identify yeast •Confirm presence of Candida in qualifying respiratory samples •Sending respiratory samples to OPHL Pharmacy •Checking treatment allocation •IP preparation & dispensing •Dose adjustments for renal disease •IP Accountability Pre-Study Activities Required Documentation REB Approval REB Approved Consent Fully-Executed Site Agreement Team Qualifications Delegation of Authority CVs & Licenses Overall Pharmacy Local Laboratory Laboratory Accreditation & Reference Ranges CRS Access Logs Study Coordinators Pharmacy Implementation Manual pg. 9 Delegation of Authority Must be kept up to date throughout the duration of the study. Implementation Manual pg. 9 Training All study related training should be documented. Any study related training initiated at the site should be documented and a copy sent to CERU PL CRS Access Log Implementation Manual pg. 10 Screening & Randomization Inclusion Criteria Implementation Manual pg. 14 Entering screening data for a new patient: Drop-down Check boxes Drop-down Exclusion Criteria Implementation Manual pg. 18 Eligibility Confirmation Should have documented confirmation from MD regarding patient eligibility Patient enrolled in CANTREAT study. Patient randomized to the study at hrs. Patient met all the inclusion criteria and none of the exclusion criteria. Eligibility confirmed with Dr. ______________. Consent obtained from _____________ (relationship to pt) on dd/mmm/yyyy at hrs. All questions & concerns addressed with SDM at this time. Copy of consent given to SDM. Date/time of entry: ____________ Signature of writer: ____________ Consent = NO Indicate the reason why consent was NOT obtained Obtaining Informed Consent Timing: When? Consent must be obtained within 96 hrs of the Candida +ve respiratory specimen sample time Who obtains consent? Site Investigator or delegate i.e. sub investigator or research nurse Must be specified on the Delegation of Authority Log Implementation Manual pg. 21 Whom to Get Consent from? Patients are often incapable given acuity of illness Substitute decision maker (SDM) or patient’s legally acceptable representative Explain the Study Procedures Explain VAP and treatment of identified bacterial organism as standard of care Presence of Candida “yeast” in the sputum, usually NOT treated Purpose of the study is to determine if treating Candida, with antibiotics effective against Candida, in addition to the usual antibiotics administered for lung infections will improve the outcome of these infections. Explain Study Procedures Study Treatment: GROUP 1: Standard ICU Care + antibiotic for Candida GROUP 2: Standard ICU Care + Placebo (placebo oral solution or a bag of salt water intravenously) Risks & benefits Blood will be taken on days 1, 3, 8 & 14 to help us understand how Follow up at 90 days to check on patients status If Consent Obtained, Remember to: Ensure SDM has signed and dated the ICF Place original in study files, copy to medical chart & copy to SDM Write a note in the medical chart stating: Name of SDM who provided consent, relation to patient Date and time that consent was received Time that patient was randomized Telephone Consent Document in the medical chart that consent was obtained via telephone before the patient was randomized Follow up with the SDM to see that the ICF is signed as soon as possible. Consent Tools Consent template ICF Essential Elements Checklist Sample Medical Chart entry Consent = YES We are interested in knowing any academic studies the patient is co-enrolled in. Study Procedures Study Procedures Manual MD Orders STUDY BLOOD WORK Blood specimens should be drawn on the following days: o Randomization day = study day 1, pre-treatment o On study day 3 o On study day 8 o On study day 14 or last day of treatment, whichever comes first Each blood draw includes: o 1 green top (sodium heparin) vacutainer o 1 dark blue (trace element-free) top vacutainer Blood draws are to be coordinated with the research nurse. STUDY DRUG ADMINISTRATION Implementation Manual pg. 26 Administer once daily for 14 days o If discharged to the ward before 14 days of study intervention received, study drug administration should continue on the ward until 14 days received. o If patient discharged from the hospital before 14 days of study intervention received, study drug should be stopped on hospital discharge. Begin study drug administration intravenously. If the gastro-intestinal tract becomes functional based on tolerance to feeds or diet, study drug will then be converted to oral form. A separate order for conversion to oral will be written. If route of administration = intravenous: o Administer study drug at the rate indicated on the product label. o Study drug is compatible only with normal saline or D5W. If route of administration = oral: o Administer 40 mL of investigational product via NG tube or orally. Dose Adjustments for patients with renal disease: o Notify research Pharmacist or research coordinator if creatinine is outside the normal range. o Research Pharmacist to adjust study drug dosage as per protocol. Study Intervention Antifungal Therapy (anidulafungin and fluconazole) OR Placebo Study Intervention: Active Treatment Arm Products provided by Pfizer Generic name: anidulafungin Trade name: Eraxis™ IV administration Generic name: fluconazole Trade name: Diflucan Oral administration Study Intervention: Placebo arm Normal saline OR D5W IV Administration Infusion solution must be administered within 24 hours Should be stored at room temperature To be infused over 2-4 hours, as per pharmacy instructions Oral Administration Via NG tube or orally Administer 40mL OD Should be stored at room temperature Duration of Study Treatment Administered once daily Routes of administration: IV or PO Total of 14 days Continue if discharged to the ward Exception: patients discharged from hospital before 14 days of study treatment completed, discharge day = last day of study treatment Implementation Manual pg. 27-29 Initiating Study Treatment 1. 2. 3. 4. Following randomization, notify the Pharmacy Pharmacist will determine treatment code by logging into CRS (UNBLINDED) Pharmacy prepares study treatment Administration of study treatment should start within 2 hours of randomization Things to consider once patient starts to receive IP: Study Treatment Compliance Presence of renal disease or changes in renal function during the treatment period Open-label antifungal use Patient Randomized IP initiated within 2 hours IP administration initiated: Anidulafungin (Eraxis) OR Placebo IP administered via IV route minimum of 72 hrs Speciation and susceptibility results from OPHL, sent to Pharmacy to adjust IP per protocol Compatible with normal saline and DW5 “Active” treatment arm will be switched to fluconazole if organism is susceptible If patient switched to fluconazole following If gastro-intestinal tract switch to oral form, fluconazole loading functional, can switch IP to dose should be IV route, then can proceed oral route with oral Dose adjustments for renal disease. SC reports any changes is renal function to Pharmacy Anidulafungin = NO changes required Fluconazole = changes required Open-label antifungals clinically indicated, STOP IP & report Protocol Violation Last day of IP administration is Study Day 14 (including patients discharged to the ward Protocol Violations Used to report deviations in compliance with IP Should be reported to CERU in “real time” Blood Draws Type of samples Sampling schedule Local Lab Procedures Central Lab Implementation Manual pg. 30 Sample Types Vacutainer tubes will be provided to the sites Sampling Schedule Lab Responsibilities Local LPS Stimulation Blood Processing Storing Frozen samples Shipping samples to Central Lab in Ohio Central Provide sites with LPS stimulation media Provide sites with supplies Provide sites with shipping containers Analyze samples received from sites Data Collection More on Paper CRFs 2-part NCR paper Top copies of CRFs will be sent to CERU Bottom copies to remain at the site Study Days Study days defined according to the ICU flow sheet: Study Day 1 = Randomization Day Study Day 2 = Next ICU flow sheet Study Day 3 = Next ICU flow sheet Study Day 4 = etc… ICU flow sheet from 0700-0659 Implementation Manual pg. 35 Source Documentation Health Canada requires study Requireddocumentation Documents be retained for 25 years Patient Folders Worksheets & other data collection tools Study Tools Patients Folders Laminated reference cards Worksheets Patient ID List To be kept confidential Enables identification of CANTREAT study patiaents at the site Required as per Health Canada and ICH GCP Study Resources www.zapthevap.com Project Leader