Health Condition 1: A410- Sepsis due to Staphylococcus aureus Health Condition 2: A411- Sepsis due to other specified staphylococcus Health Condition 3: A412- Sepsis due to unspecified staphylococcus Health Condition 4: A413- Sepsis due to Hemophilus influenzae Health Condition 5: A414- Sepsis due to anaerobes Health Condition 6: A415- Sepsis due to other Gram-negativeorganisms Health Condition 7: A418- Other specified sepsis Health Condition 8: A419- Sepsis, unspecified organism
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Genei Laboratories Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient must be 18 years or older. 2. Patients with known or suspected blood stream infection based on clinical observations at the time of screening. 3. Patients exhibiting two or more signs of the systemic inflammatory response syndrome (SIRS): SIRS score equal to or more than 2 (SIRS will be diagnosed when two or more of the following criteria will be present: body temperature, more than 38? C (100.4? F) or less than 36? C (96.8? F); heart rate, more than 90 beats per minute; respiratory rate, equal to or more than 22 breaths per minute; white blood cell count, more than 12,000 cells per ?l or less than 4,000 cells per ?l or altered mental status). 4. Patient should be able to give informed consent if conscious or if patient is unconscious informed consent to be given by family member or LAR
Exclusion criteria
Exclusion criteria: 1. Patient less than 18 years of age. 2. Moribund patient expected to die within 24 hours. 3. After Cardiopulmonary resuscitation. 4. Any patient not willing to give informed consent. 5. Subjects requiring less than 24hours admission to the ICU (e.g. post operative patients kept for observation) and those patients who are discharged alive from the ICU without developing sepsis are excluded from the study. 6. Subjects who are mentally unsound and those unwilling to participate in the study will be excluded from the study. 7. Subjects with any other clinically significant unstable medical condition, life-threatening disease, or anything else in the opinion of the Investigator that would interfere with the study results. 8. Uncontrolled hypertension, diabetes mellitus or any other co-morbidity that is considered as an exclusion by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the sensitivity of GeNei Sepsis Kit for bacterial and fungal identification and detection of AMR genes in the whole blood of patients suspected of sepsis in comparison to conventional Blood Culture method.Timepoint: 4 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine ? Positive Predictive Value (PPV) & Negative Predictive Value (NPV) ? Turnaround time ? Concordance of the two methods - GeNei Sepsis Kit & Blood Culture ? Clinical utility of GeNeiTM Sepsis Kit ? Antimicrobial resistance gene profile of bacterial pathogens identified in positive samples. Timepoint: 4 WEEKS | — |
Countries
India
Contacts
Public ContactRohit Seshadri
CliniExperts Research Services Pvt Ltd
Outcome results
None listed