Filarial lymphedema Infections and Infestations
Conditions
Interventions
Blood samples and skin swabs will be collected from LE patients during baseline and at the onset of an ADL attack, to identify organisms associated with episodes of adenolymphangitis (ADL) attacks in
Sponsors
National Institute for Medical Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Lymphedema of at least one leg (cases) 2. Participants without lymphedema (controls) 3. Aged 18 years and above 4. Able and willing to provide informed consent (or assent, where applicable) to participate in the study
Exclusion criteria
Exclusion criteria: 1. Any significant condition (including medical and psychological/psychiatric disorders) that, in the opinion of the study clinician, might interfere with the conduct of the study 2. Lymphedema of non-filarial origin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Identification of bacteria and fungi in blood collected during ADL attacks (V2 or/and V3) up to species level with NGS (mainly 16/18s) and blood culture (identification with MALDI-TOF or Vitek 2 Compact System) before and during attacks 2. Identification of bacteria and fungi from skin swabs of the same participant taken at ADL and baseline (V1), using NGS and cultures from cryopreserved microbial isolates (for methods of identification see above), and NGS from blood samples taken at V1 3. Identification of changes or similarities in bacteria and fungi from blood and skin swabs in ADL and baseline samples (for identification methods see above) 4. Assessment of antimicrobial sensitivity of bacteria and/or fungi of medical interest, identified in outcomes 1-2, primarily using Vitek AST | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Similarities or changes in the microbiome of LE participants at baseline and during ADL, compared to that of participants in the control group at baseline, measured with NGS (mainly 16/18s) and blood culture (identification with MALDI-TOF or Vitek 2 Compact System) 2. Similarities or changes between the microbiome of participants grouped by lymphedema stage measured using collected study data at baseline and during ADL with NGS (mainly 16/18s) and blood culture (identification with MALDI-TOF or Vitek 2 Compact System) 3. Immune response during ADL attacks is analyzed from whole blood samples collected at baseline and ADL. Peripheral Blood Mononuclear Cells (PBMCs) and plasma are prepared. In PBMCs, the immune cell populations (e.g., T cells and granulocytes) are analyzed using flow cytometry. Plasma is used to analyze pro-inflammatory and Th1/Th2/Th17 immune responses and chemokines using Luminex and ELISA techniques. | — |
Countries
Tanzania
Contacts
Public ContactAbdallah Ngenya
Outcome results
None listed