Severe Bacterial Infection Clinical Trial
Official title:
PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring, International Registry on the Use of Pentaglobin® in Patients With Severe Bacterial Infections
International registry on the use of Pentaglobin® in patients with severe bacterial infections; multicentric, international registry, non-interventional trial
Aim of the Pentaglobin® registry of adult critically ill patients with severe infections is primarily to assess the effects of IVIgAM on the aforementioned outcome parameters and its side effects under real-life conditions based on a prospective, high-quality data documentation - Age ≥ 18 years - Diagnosis of severe bacterial infection - Pentaglobin® use - signed informed consent for data collection Exclusion criteria None Primary endpoints - Comparison APACHE II and SAPS II predicted mortality vs. observed hospital mortality and - Difference in SOFA scores, baseline vs. posttreatment (24 h after last application) assessment Secondary endpoints - In-hospital mortality total and in subgroups according to baseline IgM serum levels (< 80 mg/dL vs. ≥ 80 mg/dL) and baseline CRP (< 70 mg/L vs. ≥ 70 mg/L) - Change in MOF score from the day before treatment start till 24 h after last application of Pentaglobin - Course of laboratory markers (concentration-difference): CRP, procalcitonin, IL-6, IgM, IgA, IgG before treatment start till 24 h after last application as far as available in the centers - Duration of ICU stay (days) - Duration of hospital stay (days) - Time from onset of severe bacterial infection to start of treatment ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02760745 -
Fever and Shivering: Frequency and Role in Predicting Serious Bacterial Infection
|
N/A |