Filarial lymphedema Infections and Infestations
Conditions
Interventions
Blood samples and skin swabs will be collected from lymphedema (LE) patients during baseline and at the onset of an ADL attack, to identify organisms associated with episodes of adenolymphangitis (ADL
Sponsors
Kumasi Centre for Collaborative Research in Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female participants 18 years of age and above with/without LE (cases/controls) (LEDoxy clinical trial cohorts, previously screened but excluded LEDoxy LE participants, LE participants in the community willing to join the study + controls with a similar working/housing environment)
Exclusion criteria
Exclusion criteria: 1. Male and female participants below 18 years of age 2. LE of non-filarial origin 3. Any other condition or severe comorbidities (except for features of the filarial disease) that, in the opinion of the study team, would risk the safety or rights of a participant or would render the participant unable to comply with the protocol 4. Inability or unwillingness of study participant to give informed consent to participate in the study
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. Identifying 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 2. Identifying similarities or changes between the microbiome of participants grouped by lymphedema stage measured using collected study data at baseline and during ADL 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 proinflammatory and Th1/Th2/Th17 immune responses and chemokines using Luminex and ELISA techniques. | — |
Countries
Ghana
Contacts
Public ContactLinda Batsa Debrah
Outcome results
None listed