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
Verified date | November 25, 2008 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1500 |
Est. completion date | |
Est. primary completion date | October 4, 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 65 Years |
Eligibility |
- INCLUSION CRITERIA - SCREENING: Age 14 to 65. Both genders. Not pregnant or breastfeeding by history. EXCLUSION CRITERIA - SCREENING: Non-volunteers. Age less than 14 or greater than 65. Pregnant or breastfeeding by history. INCLUSION CRITERIA - TREATMENT: Age 14 to 65 years. Men and non-pregnant or breastfeeding women. EXCLUSION CRITERIA - TREATMENT: Non-volunteers. Age less than 14 or greater than 65. Pregnancy or breast-feeding. Hgb less than or equal to 10 g/dl. Cr greater than 1.4/100 ml. ALT greater than 45 U or bilirubin greater than 1.5. Weight less than 40 kg. Heavy alcohol use (more than 1 beer or other alcohol-containing drink/day). Temperature greater than 37.5C or other serious medical illnesses. History of allergy to doxycycline or other tetracyclines. History of HIV infection or other immunocompromised state. |
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Addiss DG, Beach MJ, Streit TG, Lutwick S, LeConte FH, Lafontant JG, Hightower AW, Lammie PJ. Randomised placebo-controlled comparison of ivermectin and albendazole alone and in combination for Wuchereria bancrofti microfilaraemia in Haitian children. Lancet. 1997 Aug 16;350(9076):480-4. Erratum in: Lancet 1997 Oct 4;350(9083):1036. — View Citation
Beach MJ, Streit TG, Addiss DG, Prospere R, Roberts JM, Lammie PJ. Assessment of combined ivermectin and albendazole for treatment of intestinal helminth and Wuchereria bancrofti infections in Haitian schoolchildren. Am J Trop Med Hyg. 1999 Mar;60(3):479-86. — View Citation
Horton J, Witt C, Ottesen EA, Lazdins JK, Addiss DG, Awadzi K, Beach MJ, Belizario VY, Dunyo SK, Espinel M, Gyapong JO, Hossain M, Ismail MM, Jayakody RL, Lammie PJ, Makunde W, Richard-Lenoble D, Selve B, Shenoy RK, Simonsen PE, Wamae CN, Weerasooriya MV. An analysis of the safety of the single dose, two drug regimens used in programmes to eliminate lymphatic filariasis. Parasitology. 2000;121 Suppl:S147-60. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Greater than or equal to 50 percent of Mp microfilaremia at 1 year in response to doxycycline treatment in study volunteers with Mp infection. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02281643 -
Concomitant Infections of Mansonella Perstans in Tuberculosis and Buruli Ulcer Disease Patients From Ghana
|
Phase 2 |