|- candidate number||10800|
|- NTR Number||NTR3219|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-dec-2011|
|- Secondary IDs||2011.10 Scientific Review Committee of the MRU (Medical Research Unit) of the Albert Schweitzer Hospital|
|- Public Title||The Immune Response during Sepsis in a Tropical setting; The impact of co-infection with HIV or malaria.|
|- Scientific Title||The Immune Response during Sepsis in a Tropical setting; The impact of co-infection with HIV or malaria.|
|- hypothesis||Co-infection with either HIV or malaria may have a major impact on the immune response during bacterial sepsis. Current knowledge on the pathogenesis of sepsis indicates an unbalanced response to infection characterized by both excessive pro-inflammatory responses and immune suppression. This disturbance is expected to be even more profound in the presence of HIV/malaria co-infection, at least in part due to hyper-responsiveness of PRRs triggering innate immunity. |
|- Healt Condition(s) or Problem(s) studied||Sepsis, HIV infection, Malaria|
|- Inclusion criteria||1. Admission to Albert Schweitzer Hospital;|
2. Age >17;
3. Temperature <36°C or >38° C;
4. One additional SIRS criterion (Heart rate >90bpm, Respiratory rate >20/min or leukocytes <4e9 g/L or >12e9 g/L).
|- Exclusion criteria||No informed consent.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||15-jan-2011|
|- planned closingdate||15-feb-2015|
|- Target number of participants||2500|
|- Interventions||Venous blood draw.|
|- Primary outcome||Blood culture results, admission related mortality. In those with positive blood cultures: Sepsis related organ failure, systemic and cell specific markers of inflammation.|
|- Secondary outcome||All cause mortality.|
|- Timepoints||Blood culture results: Maximum timepoint 7 days after admission.|
Admission related mortality: Maximum timepoint 3 weeks after admission.
Sepsis related organ failure: Monitoring during admission.
Systemic markers of inflammation: Day 0, 2, 6 and 30.
Cell specific markers of inflammation: Day 2.
All cause mortality: 6 months.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Mischa Huson|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Tom Poll, van der|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Bacterial sepsis is a major cause of death in Africa. Recent evidence indicates that African patients with culture confirmed bloodstream infection are frequently co-infected with either HIV or malaria. Knowledge on the impact of these co-infections on the immune response during bacterial sepsis is highly limited. Therefore we will perform a prospective observational study to determine the impact of co-infection with HIV or malaria on the immune response during bacterial sepsis and its influence on clinical outcome. At the same time, we will identify micro-organisms causing sepsis and their antimicrobial resistance patterns. Patients will be recruited in the Albert Schweitzer hospital in Lambaréne, Gabon. We expect to enroll 2500 patients with symptoms indicating sepsis, of which an estimated 250 will have positive blood cultures. Cohorts (N = 50 per cohort) will be constituted consisting of patients with culture confirmed bacterial sepsis with or without co-infection with HIV or malaria, and afebrile controls without bacterial infection and with or without chronic HIV or malaria. In whole blood, plasma and purified blood cell populations, pro-inflammatory and anti-inflammatory markers known to be important in sepsis pathogenesis will be measured. In addition, gene expression profiles of purified cells will be compared using whole genome microarrays to discover new genes or pathways involved in sepsis pathogenesis. |
|- Main changes (audit trail)||24-3-2014: exclusie criteria verwijderd: |
1. Clinical tuberculosis;
2. Active viral hepatitis;
3. Expected duration of admission <24 hours;
4. Clinical signs of severe anemia or Hb <7 mg/dl.
|- RECORD||29-dec-2011 - 24-mrt-2014|