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Filariasis clinical trials

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NCT ID: NCT01905436 Completed - Onchocerciasis Clinical Trials

Mass Drug Administration for Lymphatic Filariasis and Onchocerciasis for Liberia

DOLF-LIBERIA
Start date: March 2012
Phase:
Study type: Observational

Approximately 5,200 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis and onchocerciasis endemic areas. Subject selection will not be based on health status. Two sites will be studied, and each study will last for 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic filariasis and onchocerciasis, and investigators will compare the impact of these MDA schedules on soil transmitted helminth infections. MDA will be administered by others (Liberian Ministry of Health or Liberian Institute of Biomedical Research). The investigators will test the hypothesis that semiannual mass drug administration (MDA) is superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for control of soil transmitted helminth (STH) infections. 1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF) in these populations. 2. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of onchocerciasis in these populations. 3. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations. Continuation Activities (2019/2020): Additional one-time cross-sectional surveys will be completed in the Harper site in Maryland district in 2019 and in Lofa in 2020 to measure the long-term impact of MDA on W. bancrofti, O. volvulus, and on STH infection parameters following these cumulative 7-9 rounds of MDA since the baseline survey taken in 2013. Since the last DOLF surveys (3rd follow-ups) in these sites in 2016 & 2017, respectively, there have been a total of 3 annual rounds of MDA in both areas. These additional surveys will recruit 2,500 participants in the Maryland area villages and 3,200 in the Lofa area villages.

NCT ID: NCT01905423 Completed - Clinical trials for Lymphatic Filariasis

Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis

DOLF-Indo
Start date: May 2011
Phase:
Study type: Observational

Approximately 3,500 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis endemic areas. The study will be performed in Indonesia in B. timori and W. bancrofti endemic areas over a period of 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Purpose of the study is to evaluate different mass drug administration (MDA) regimens for lymphatic filariasis and also to study the impact of MDA on soil transmitted helminth infections (STH). MDA will administered by others (e.g., Ministry of Health). Results of this study may enhance efforts to control and eliminate these important neglected tropical diseases. The investigators will test the hypothesis that accelerated mass drug administration will be superior to annual MDA for elimination of lymphatic filariasis and for control of soil transmitted helminth infections (STH): 1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF). 2. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.

NCT ID: NCT01903057 Withdrawn - Trachoma Clinical Trials

Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis

AZIVAL2
Start date: February 2014
Phase: Phase 4
Study type: Interventional

Trachoma and lymphatic filariasis (LF) are two 'Neglected Tropical Diseases' (NTDs), infectious diseases that affect millions of poor people in countries in the developing world. Trachoma is an eye infection that can lead to painful scarring of the eyelids and blindness later in life. LF can lead to swelling of usually the limbs (elephantiasis). Trachoma and LF are preventable and treatable diseases. One important treatment strategy is annual Mass Drug Administration (MDA): Communities receive drug treatment once a year. Azithromycin is given for trachoma. Ivermectin and albendazole are given for LF. Trachoma MDA and LF MDA are currently separated campaigns. Combined MDA campaigns for trachoma and LF, where three drugs would be given at one time, would reduce costs and decrease the burden on the health system. Before combined MDA with three drugs (azithromycin, ivermectin and albendazole) could be recommended, we would have to demonstrate that the safety profile of this treatment with three drugs is acceptable. An earlier study in Mali in 2010 (AZIVAL) comparing standard MDA (one week space between the two MDA campaigns) with combined MDA (trachoma and LF MDA on the same day) showed that the safety profiles were comparable; but the results of the study were not statistically significant and we could not use them to make an official recommendation. The AZIVAL 2 study has been designed to answer the questions that remain after the AZIVAL study performed in Mali in 2010. If the safety results of the AZIVAL 2 study are acceptable, an official recommendation for combined MDA with azithromycin, ivermectin and albendazole can be drafted. We will conduct the AZIVAL 2 study in Mozambique. The target population (inclusion and exclusion criteria) is the same as in the AZIVAL study in Mali. Main criteria are: Age ≥ 5 years and ≤ 65 years, height ≥ 90 cm, if female, not pregnant or breast-feeding. Important differences between the AZIVAL study and the AZIVAL 2 study are a) smaller clusters for sufficient power (average household size is 5 people), b) placebo to double-blind participants and study staff for azithromycin, c) the study area will have undergone fewer previous rounds of MDA for LF and none for trachoma, and d) smartphones for data entry.

NCT ID: NCT01629771 Completed - Clinical trials for Lymphatic Filariasis

Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India

Start date: May 2012
Phase: N/A
Study type: Observational

According to the World Health Organization, lymphatic filariasis, a mosquito-borne parasitic disease, is the second leading cause of disability worldwide. Across 81 countries, approximately 120 million people are infected with the disease, and of those infected, an estimated 40% reside in India alone. The most disfiguring symptoms of lymphatic filariasis, elephantiasis and lymphedema, cause long-term suffering in patients who are then often embarrassed or even rejected from their communities. Because of the disease's debilitating physical and social effects on patients, this study will explore the intersection of disability and health-related quality of life (HRQoL) in lymphatic filariasis patients in India. Specifically, HRQoL and disability in lymphatic filariasis subjects and age- and gender- matched control subjects will be compared. Two HRQoL tools , the general Dermatology Life Quality Index (DLQI) and a disease-specific instrument developed by a dermatology group in India will be used to gauge HRQol. In addition, the demographic and disease-specific factors associated with HRQoL and disability in filarial lymphedema subjects will be identified.

NCT ID: NCT01628497 Completed - Filariasis Clinical Trials

Exhaled NO Testing in Filariasis

Start date: May 2012
Phase: N/A
Study type: Observational

This study is looking at the difference in exhaled nitric oxide levels in patients with and without laboratory evidence of filariasis.

NCT ID: NCT01586169 Completed - Parasitic Diseases Clinical Trials

Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination

AZIVAL
Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the triple co administration of albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that consists to treat with albendazole plus ivermectin together and a week later to treat with azithromycin in areas co endemic for lymphatic filariasis and trachoma.

NCT ID: NCT01547884 Completed - Tuberculosis Clinical Trials

Effect of Filarial Infection on Immune Responses in Latent Tuberculosis

Start date: January 1, 2013
Phase:
Study type: Observational

Background: - Lymphatic filariasis is an infection that is caused by small, thread-like worms. It is spread by mosquitoes, and causes fever, chills, and headaches. If untreated, it can also cause elephantiasis, a condition that leads to swelling of the arms, legs, breasts, and scrotum. Treatment can eliminate the worms from the blood and reduce the risk of developing elephantiasis. Researchers want to study people with latent tuberculosis (TB) who may or may not be infected with filariasis. This study will look at the way that people with latent TB fight infection with these worms. Objectives: - To study how the immune systems of people with latent TB react to filarial infection. Eligibility: - Individuals between 18 and 65 years of age who have latent TB and may or may not have filarial infection. Design: - Participants will be screened with a physical exam and medical history. They will provide a blood and stool sample to test for infection. - Participants who do not have lymphatic filariasis but have another kind of intestinal worm will be treated for the parasite. This will be their last study visit. - Participants who have latent TB and lymphatic filariasis will be treated with the standard treatment for the disease. They will come back for a second visit 6 months later, and will provide another blood sample.

NCT ID: NCT01213576 Terminated - Clinical trials for Lymphatic Filariasis

Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi

FED
Start date: January 2009
Phase: N/A
Study type: Interventional

Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such programmes is very high and has proven to be a major impediment to the success of programmes in many countries with limited financial resources. Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. It is essential to determine whether such higher doses are indeed beneficial since this could have far-reaching effects on the conduct and management of the main mass treatment programmes and also in the management of programmes as they near elimination.

NCT ID: NCT00511004 Completed - Clinical trials for Lymphatic Filariasis

Effect of Albendazole Dose on Treatment of Lymphatic Filariasis

Start date: July 2007
Phase: Phase 2
Study type: Interventional

This study is conducted in Kerala, India. It will determine whether a new treatment regimen of albendazole and diethylcarbamazine (DEC) for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small parasitic worms that are spread by mosquitoes. The disease can cause swelling of the arms, legs, breast and scrotum and can progress to permanent swelling of the legs or arms called elephantiasis. The study will see if a higher and more frequent dose of albendazole is better at clearing filarial worms from the blood than the current treatment. Healthy people between 18 and 55 years of age who are in good health and who are infected with filarial worms may be eligible for this study. Participants undergo the following procedures: 3-day hospital stay at the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital in Kerala, India - Random assignment to receive either: 400 mg albendazole and DEC 300 mg given once a year for 2 years (standard treatment); or 800 mg albendazole and DEC 300 mg given once a year for 2 years; or 800 mg albendazole and DEC 300 mg given twice a year for 2 years. - Urine pregnancy test for women of childbearing age . - Ultrasound test to look for filarial worms. - Treatment dose. - Monitoring for symptoms 6-month 3-day hospital stay - Medical history, physical examination and blood test. - Repeat ultrasound in subjects whose first ultrasound detected adult worms. - Treatment dose for subjects receiving medicine every 6 months. - Urine pregnancy test for women of childbearing age. 1-year 3-day hospital stay - Medical history, physical examination and blood test. - Treatment dose. - Repeat ultrasound in subjects whose first ultrasound detected adult worms. - Urine pregnancy test for women of childbearing age. 18-month 3-day hospital stay - Medical history, physical examination and blood test. - Treatment dose for subjects receiving medicine every 6 months. - Urine pregnancy test for women of childbearing age. 24-month 3-day hospital stay - Medical history, physical examination and blood test. - Treatment dose. - Repeat ultrasound in subjects whose first ultrasound detected adult worms. - Urine pregnancy test for women of childbearing age.

NCT ID: NCT00471666 Completed - Malaria Clinical Trials

Medical Implications of Coinfection With Malaria and Filariasis Parasites

Start date: May 7, 2007
Phase: N/A
Study type: Observational

This study will examine the clinical, immunological and epidemiological effects of concurrent infections with P. falciparum and W. bancrofti or M. perstans (the parasites that cause malaria and filariasis) on the frequency and severity of malaria infection in children and young adults in Mali, Africa. Residents of Tien gu bougou and Bougoudiana, Mali, who are between 1 and 20 years of age may be eligible for this study. Participants with and without filarial infection will be enrolled. Participants undergo the following tests and procedures: - Baseline evaluation with medical history and physical examination, blood tests and stool culture - Brief physical examinations weekly - Blood tests monthly for malaria - Standard treatment offered for anyone with malaria - Blood tests for filarial infection at the beginning, midpoint and end of the transmission season - Treatment for lymphatic filariasis is available through the National Program for the Elimination of Lymphatic Filariasis. There is no effective standard therapy for M. perstans. - Treatment for other parasitic worm infections, if needed.