Background and study aims
Lymphatic filariasis is a parasitic disease caused by microscopic, thread-like worms that infect the lymph system. The worms are transmitted by mosquitoes that take up baby worms (microfilariae) during a blood meal and can later pass the developed larvae to another person. The infection can cause fluid collection and swelling (lymphedema) but can also go unnoticed by the infected person. Previous studies showed that doxycycline 100-200 mg given daily for 4-6 weeks could kill the adult worms and therefore is more effective in fighting the disease than the standard mass drug administration used in Ghana and Tanzania. Another promising treatment is the double-drug combination using moxidectin plus albendazole (MoxA). ALB is an approved drug for the treatment of lymphatic filariasis (LF). Moxidectin (Mox) has a similar safety profile as ivermectin and is approved for another filarial disease that causes river blindness (onchocerciasis). MoxA is currently being evaluated in several clinical trials, including treatment against LF. Because these treatments target adult worms, they will potentially eliminate parasite reservoirs within transmission units and across entire countries/regions. In order to eliminate this disease and prevent infection of more people, it is important to find and treat all infected people, even if they are not aware of the infection. Therefore, the aim of this study is to find the best way to reach this goal and finally eliminate lymphatic filariasis.
What does the study involve?
Lymphatic filariasis infected participants from six hotspots study areas in Ghana and Tanzania (three hotspots per country) will be treated with doxycycline 100 mg for 5 weeks (35 days) plus a single dose of ivermectin plus albendazole at the end of the DOX treatment or 8 mg moxidectin plus 400 mg albendazole (MoxA). A control group will only be given the standard MDA medication, ivermectin 200 mcg/kg plus albendazole 400 mg (“IA”).
Each of the six study areas will be assigned randomly to one of the following groups: group A, (interventional; “DOX”), group B (interventional, “MoxA”) or group C (control, “IA”). All participants from the communities randomized to group A (“DOX”) or group C (control group) will receive ivermectin 200 mcg/kg plus albendazole 400 mg (“IA”) in cooperation with the national programs at the study start. Participants of communities randomized to group B (MoxA) will not receive “IA” but a MoxA single dose. In the case of MF-positive participants at 12 months in any of the three groups, these participants will receive IA one more time at 12 months (groups A and C) or MoxA one more time or also IA (group B).
At study start and around 12 and 24 months later, blood, urine and stool samples (some participants) will be collected. Men will be asked for an ultrasound examination of their scrotum to confirm infection (optional). A questionnaire about acute attacks is carried out at every contact with the study team.
Participarting Centers?
1. Kumasi Centre for Collaborative Research (KCCR) (Ghana)
2. The National Institute for Medical Research (NIMR) (Tanzania)
