Mansonella Perstans Infection Clinical Trial
Official title:
Treatment of Mansonella Perstans Infection in an Area Coendemic for Lymphatic Filariasis: A Pilot Study of the Effects of Doxycycline
This study will examine: 1) the safety and effectiveness of the drug doxycycline in reducing
the number of Mansonella perstans (Mp) worms in the blood of infected patients, and 2) the
effects of doxycycline followed by albendazole and ivermectin treatment for lymphatic
filariasis, caused by the parasitic worm Wuchereria bancofti (Wb).
Both Mp and Wb very small filarial worms that are spread by mosquitoes. Some people are
infected with both Mp and Wb. Although most people do not become ill from infection with
these parasites, some develop symptoms. Wb can cause swellings in the arms, legs, breast, and
scrotum, and can progress to permanent swelling of the legs or arms called elephantiasis. Mp
can cause itching, swelling, fever, headache, or other symptoms. Ivermectin and albendazole
are medicines used to treat lymphatic filariasis. They eliminate the Wb parasite from the
blood but do not affect Mp. Doxycycline is used to treat many kinds of infections and has
also recently been shown to reduce the number of filarial worms in several types of filarial
infections. The drug may be useful in Mp infections as well.
Residents of Sabougou and nearby villages in Mali who are infected with the Mp parasite, are
between 14 and 65 years of age, are in good health, are not pregnant or breastfeeding, and
weigh at least 40 kg (88 lb) may be eligible for this study. They may or may not also be
infected with Wb. Candidates are screened with a brief medical history and physical
examination and blood tests to look for infection with Mp and Wb.
Participants undergo a complete physical examination and medical history. Blood is drawn for
routine blood tests. Participants are then randomly assigned to one of four treatment groups,
as follows: 1) doxycycline for 6 weeks; 2) doxycycline for 6 weeks followed by a single dose
of albendazole and ivermectin given 6 months after the beginning of doxycycline treatment; 3)
a single dose of albendazole and ivermectin given 6 months after the beginning of doxycycline
treatment; or 4) no treatment. Only patients infected with Wb receive albendazole and
ivermectin treatment.
All participants, whether or not they receive doxycycline, come to the clinic every day for 6
weeks. Every 2 weeks during this time, they have a blood test and, in women of childbearing
age, a urine pregnancy test. After 6 months, they have a medical history, physical
examination, and blood tests. Subjects in the albendazole/ivermectin treatment group are
given the pills to take at that time. One year and three years after beginning the study,
participants return to the clinic for a final history, physical examination, and blood tests.
At the end of the first year of the study, all participants who tested positive for lymphatic
filariasis but did not receive ivermectin and albendazole will be offered treatment with
these medicines Ivermectin and albendazole will also be distributed by the Mali government to
everyone in the villages as part of a program to eliminate lymphatic filariasis in the
country.
Mansonella perstans (Mp) infection is common in areas of Africa that are endemic for Wuchereria bancrofti (Wb), a causative agent of lymphatic filariasis. The clinical and immunologic contributions of Mp infection in this setting are unknown, in part because of the lack of response of Mp to standard antifilarial therapies. The recent discovery of bacterial endosymbionts (Wolbachia) in a number of filarial species, including Mp, has led to new therapeutic options for reducing microfilaremia. Volunteers between the ages of 14 and 65 will be screened in order to identify 240 volunteers (160 Wb+Mp+ and 80 Wb-Mp+) for participation in an open label randomized trial of doxycycline (200 mg daily for 6 weeks). Wb+Mp+ subjects will then be randomized to receive single dose treatment with albendazole and ivermectin 4 months after completion of the doxycycline treatment or no further treatment. Clinical, parasitologic and immunologic assessments will be performed prior to the initiation of treatment and at 6 months and 1 year and 3 years following initiation of treatment. The efficacy of doxycycline treatment in reducing Mp microfilaremia will be assessed in subjects with and without Wb coinfection. In addition, the effect of subsequent administration of albendazole/ivermectin on Mp clearance will be assessed in coinfected subjects. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02281643 -
Concomitant Infections of Mansonella Perstans in Tuberculosis and Buruli Ulcer Disease Patients From Ghana
|
Phase 2 |