Doxycycline to Treat Mansonella Perstans Infection in Patients With and Without Lymphatic Filariasis
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)