Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Diagnostic kit Leptoplex: Clinical Evaluation of a Novel Multiplex PCR Panel (LipL21, LipL32, LipL41) for Leptospirosis Diagnosis in Kancheepuram District-[LEPTOPLEX] for duration of on
Sponsors
Farida Fahhima A
Eligibility
Inclusion criteria
Inclusion criteria: Patients of all ages and genders presenting with clinical suspicion of leptospirosis and who can provide informed consent written consent for adults greater or equal to 18 years, and parental or guardian consent for minors.
Exclusion criteria
Exclusion criteria: Non-suspected cases and patients unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the sensitivity and specificity of the LEPTOPLEX Multiplex PCR assay for diagnosis of leptospirosis.Timepoint: Primary outcome (sensitivity and specificity of LEPTOPLEX Multiplex PCR) was assessed at baseline (Day 0), at the time of first clinical presentation, in patients presenting within less than or equal to 7 days of fever onset | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes included phase-wise diagnostic performance, agreement with MAT, comparison with conventional PCR, turnaround time, gene-wise positivity, and incremental diagnostic yield of the LEPTOPLEX assay.Timepoint: Secondary outcomes were assessed at baseline (Day 0), during early (Days 1 3) and late acute phases (Days 4 7), and during the convalescent phase (Days 8 14), with final outcome assessment at Day 14 21 or discharge. | — |
Countries
India
Contacts
Public ContactDr.Nisha B
Saveetha Medical College and Hospital
Outcome results
None listed