Lymphatic filariasis (LF) Infections and Infestations Lymphatic filariasis (LF)
Conditions
Interventions
Current interventions as of 03/08/2018 to 18/12/2024:
The study involves daily observed treatment with either doxycycline 200mg for 6 weeks, doxycycline 100mg for 6 weeks or placebo matching doxycycli
ivermectin 200µg/kg plus albendazole 400mg) in areas where MDA is still ongoing. Treatment is carried out in a blinded manner, meaning that neither the patients nor the caregiver know to which treatme
Sponsors
The National Institute of Medical Research (NIMR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Lymphedema of at least one leg grade 1-6 measured on a 7-point scale [3] 2. Age = 14 years and = 65 years 3. Men or non-pregnant women. If women of childbearing-potential, they must use an approved, effective method of contraception (including abstinence) before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo 4. Negative pregnancy test 5. Body weight = 40 kg 6. Resident in LF endemic area for = 2 years 7. Able and willing to give informed consent/ to provide assent to participate in the trial 8. Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment
Exclusion criteria
Exclusion criteria: 1. No lymphedema or lymphedema stage 7 2. Age 65 years 3. Body weight 2 times upper limit of normal 20. AST (GOT) > 2 times upper limit of normal 21. ALT (GPT) > 2 times upper limit of normal 22. Gamma-GT > 2 times upper limit of normal 23. Positive urine pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lack of progression of lymphedema (LE) (stage reduction or same stage as pre-treatment using the 7-point scale staging according to Dreyer et al, 2002), examined 24 months after treatment onset | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/12/2024: 1. Lack of progression of LE (stage reduction or same stage as pre-treatment using the 7-point scale staging according to Dreyer et al., 2002), examined 6, 12 or 18 months after treatment onset and at the Follow-Up Visit 2. Improvement of LE, i.e. stage reduction (at least one stage compared to pre-treatment), examined 6, 12, 18 and 24 months after treatment onset and at the Follow-Up Visit 3. Change of LE stages (reduction or increase) compared to baseline, assessed at 6, 12, 18 and 24 months after treatment onset and at the Follow-Up Visit 4. Changes (reduction or increase) of the circumference of the affected limbs compared to baseline circumferences, measured by tape measure at 6, 12 and 24 months after treatment onset and at the Follow-Up Visit 5. Changes in skin thickness of the affected limbs compared to baseline values, measured by ultrasound at 6, 12 and 24 months after treatment onset (outcome measure removed as of 03/08/2018) 6. Changes in the circumference of the affected limbs compared to baseline circumferences, measured with an infrared scanner (LymphaTech®) at 6, 12 and 24 months after treatment onset and at the Follow-Up Visit 7. Changes in the volume of the affected limbs compared to baseline volume, measured with an infrared scanner (LymphaTech®) at 6, 12 and 24 months after treatment onset and at the Follow-Up Visit 8. Changes in the duration of acute attacks compared to pre-treatment, as assessed with a questionnaire every two months after treatment onset and evaluated at 6, 12 and 24 months after treatment onset and at the Follow-Up Visit 9. Changes in the frequency of acute attacks compared to pre-treatment, as assessed with a questionnaire every two months after treatment onset and evaluated at 6, 12 and 24 months after treatment onset and at the Follow-Up Visit 10. Absence of acute attacks, as assessed with a questionnaire every two months after treatment onset and evaluated at 6, 12 and 2 | — |
Countries
Tanzania
Contacts
Public ContactAkili Kalinga
Outcome results
None listed