Sepsis MedDRA version: 20.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Prevenar 13
Product Name: Prevenar 13
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female adult patients aged 18 years or older on the date of screening for the trial - Registered with a General practitioner - Reason for admission to intensive care unit or high dependence unit was sepsis. - Clinical condition has improved and the patient is ready for step down to HDU or ward based care in the next 24 – 48 hours - Provision of written informed consent by the patient OR by patient’s Legal Representative OR Professional Consultee Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 214 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 214
Exclusion criteria
Exclusion criteria: - Core temperature =38.0°C within the past 24 hours prior to study IMP administration. As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. - Hypersensitivity reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine. - Recent vaccination defined as any vaccination administered to subjects within 7 days of enrolment. - Pregnant and lactating women. - Limitations of care set including not for resuscitation, not for readmission to critical care. - Residence in a nursing home, long-term care facility, or other institution, or requirement of semiskilled nursing care. (An ambulatory subject who was a resident of a retirement home or village is eligible for the trial.) - As the IMP is administered intra muscularly, coagulopathy defined as platelet count less than 50 x 109/L and/or INR greater than 1.3. For this exclusion criteria bloods taken within 72 hours of screening are valid. If these standard of care blood results are not available, then these should form part of the screening bloods for assessing eligibility. - Splenectomy (previous or in the current admission) - Diagnosis of pneumococcal sepsis in the current admission - APACHE II score defined Immune deficiency or suppression, defined as presence of 1 or more of the following conditions: - Documented human immunodeficiency virus (HIV) infection at any time-point pre-trial. If previous results are not available and/or current admission is not due to HIV infection, these patients do not need new testing and are considered eligible for the trial. - leukaemia (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years) - lymphoma (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years) - Hodgkin disease (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years) - multiple myeloma (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years) - malignancy (defined as presence of any malignancy that had been treated by or had been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years) - chronic renal failure (defined as receipt of renal dialysis or transplant) or nephrotic syndrome - receipt of immunosuppressive therapy, including steroids, within 3 months of study vaccine administration (For corticosteroids, prednisone or equivalent 0.5 mg/kg/day for 14 days or longer). Inhaled, intra- articular, and topical steroids are not considered immunosuppressive. - Receipt of an organ or bone marrow transplant with ongoing immunosuppressive medications. Failed previous transplant patients not currently on immunosuppression are eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the hazard ratio for infection related rehospitalisation or death within the 365-day follow-up period between intervention and control arm.;Primary end point(s): Differences in time to first infection related rehospitalisation or death within the 365-day follow-up period between the intervention and control arm;Timepoint(s) of evaluation of this end point: Within 365 days from IMP administration; Secondary Objective: - Derive outcome event data with necessary precision to inform future definitive trial design - To generate feasibility data and complete a focus group discussion during internal pilot phase of the trial - Describe immune recovery patterns in sepsis survivors - Describe vaccine responder characteristic | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Generating precision estimates for the proportion of rehospitalisation, proportions of reinfections, proportion of reinfection related rehospitalisation, and time to first antibiotic therapy in general practice at different follow-up time points within the 365 days follow-up period between the intervention and control arm.;Timepoint(s) of evaluation of this end point: Within 365 days from IMP administration | — |
Countries
United Kingdom
Contacts
Public ContactDr Manu Shankar-Hari
Guy's and St Thomas' NHS Foundation Trust
Outcome results
None listed