Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340691
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Doxycycline to Treat Mansonella Perstans Infection in Patients With and Without Lymphatic Filariasis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Mansonella Perstans Infection in an Area Coendemic for Lymphatic Filariasis A Pilot Study of the Effects of Doxycycline
Status:
COMPLETED
Status Verified Date:
2008-11-25
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 albendazoleivermectin 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
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 albendazoleivermectin 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
Detailed Description:
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 WbMp and 80 Wb-Mp for participation in an open label randomized trial of doxycycline 200 mg daily for 6 weeks WbMp 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 albendazoleivermectin on Mp clearance will be assessed in coinfected subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-I-N053 | None | None | None |