Lymphatic FilariasisDOLF-LIBERIANCT01905436
Mass Drug Administration for Lymphatic Filariasis and Onchocerciasis for Liberia
An observational study of Lymphatic Filariasis and Onchocerciasis, run by Washington University School of Medicine at 1 site in Liberia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Filariasis, Onchocerciasis, Soil Transmitted Helminth (STH) Infections
- What is being tested?
- Annual versus Semiannual Albendazole plus Ivermectin Mass Drug Administration
- How many people
- 21,862 participants
- Where
- 1 siteLiberia
- Study dates
- Mar 2012to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study populations are people who live in areas of Liberia that are co-endemic for lymphatic filariasis and onchocerciasis.
Who may be able to join
- • Study areas should be endemic for filariasis and onchocerciasis.
- • Study population have limited or no prior experience with MDA. Males and Females greater than 5 years of age.
Who cannot join
- • Children less than 5 years of age.
- • Children who weigh less than 15 kg (33 lb)
Trial locations and contacts
1 site in 1 country.
Liberia1 site
Liberian Institute of Biomedical Research
Charlesville, Margibi County
About this study
Official title: Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Liberia
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.
Read more
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.
- 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.
- Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of onchocerciasis in these populations.
- 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.
Read the detailed description
Lymphatic filariasis (LF) is a deforming and disabling infectious disease that causes elephantiasis and genital deformity (especially hydroceles). The infection affects some 120 million people in 81 countries in tropical and subtropical regions with well over 1 billion people at risk of acquiring the disease [1]. LF is caused by Wuchereria bancrofti and Brugia spp. (B. malayi and B.timori), nematode parasites that are transmitted by mosquitoes. This study is based on the assumption that currently used MDA regimens and schedules are not optimal for achieving elimination of LF. These regimens (either annual Albendazole (Alb) 400 mg plus diethylcarbamazine 6 mg/kg or Alb 400 mg plus Ivermectin (Iver) 200 µg/kg for LF) were introduced more than 10 years ago.
Onchocerciasis ("Oncho") is similar in some ways to LF in that it is a vector-borne nematode parasitic disease that causes severe disability. In contrast to LF, this disease causes blindness and severe skin disease rather than elephantiasis, and it is spread by black flies instead of mosquitoes. O. volvulus adult worms live in subcutaneous nodules while the adult worms of the LF parasites live in lymphatic vessels. O. volvulus adult worms are larger and less sensitive to available drug treatments than those of the species that cause LF and have a longer lifespan (approximately 14 years rather than the estimated 7 years for LF parasites). More effective drugs or dosing schedules for MDA against Oncho could shorten the number of years needed to interrupt Oncho transmission in areas that previously had high disease rates.
Drugs used for LF MDA are also active against soil transmitted helminth infections (STH, e.g., Ascaris, Hookworm, and Trichuris). De-worming campaigns using anthelmintics usually target special groups of the population, such as schoolchildren, and have limited impact on transmission. Treatment of the total population and semiannual treatments may reduce re-infection considerably and will most likely lead to reduced infection densities and infection prevalence rates. Suppression of STH is an important ancillary benefit of MDA programs for filarial infections. Increasingly control programs for filariasis and STH are being integrated with programs for other parasitic diseases such as schistosomiasis. For this reason, participants will also be tested for schistosomiasis.
Purpose: The study aims to compare the effectiveness once yearly (1X) versus twice yearly (2X) mass drug administration (MDA) for the elimination of lymphatic filariasis, onchocerciasis and for control of soil-transmitted helminth infections (intestinal parasites) in large populations. Mass drug administration will be provided by the Liberian Ministry of Health. This project will assess the impact of the government's public health program.
Procedures: Study procedures include collection of finger prick blood that will be tested for microfilariae by microscopy and for serology testing (antigenemia and antibody testing). Skin snips will be collected and examined by microscopy for the presence of Onchocerca microfilariae. Stool samples will be collected for detection of parasitic worm eggs by microscopy. All assays will be performed in Liberia (filarial serology tests, microfilaria testing, stool examinations).
Washington University researchers developed the protocol, will provide training and guidance to Liberian researchers, and work with them to analyze the data. Liberian researchers will consent the participants, obtain blood, skin and stool specimens, perform laboratory tests on the specimens, and enter data on participants and lab results.
- Being tested
- Annual versus Semiannual Albendazole plus Ivermectin Mass Drug Administration
- Keywords
- Filariasis, Onchocerciasis, Albendazole, Ivermectin, STH Soil Transmitted Helminth infections, MDA Mass Drug Administration
- Medical subject headings
- Elephantiasis, Filarial, Onchocerciasis, Infections, Filariasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annual versus Semiannual Albendazole plus Ivermectin Mass Drug AdministrationDrug
Also called Albenza (Albendazole); Ivermectin, also known as Mectizan or Stromectol.
Annual or semiannual Albendazole plus Ivermectin, administered by the Liberian Ministry of Health.
| Study group | Role | What they receive |
|---|---|---|
| Annual Mass Drug Administration | This group will receive annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Liberian Ministry of Health. Receives: Drug: Annual versus Semiannual Albendazole plus Ivermectin Mass Drug Administration | |
| Semiannual Mass Drug Administration | This group will receive semi-annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Liberian Ministry of Health. Receives: Drug: Annual versus Semiannual Albendazole plus Ivermectin Mass Drug Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of W. bancrofti microfilaria (4 years)
Prevalence of W. bancrofti microfilaria (mf) is a binary outcome measured by the presence/absence of W. bancrofti mf in three-line thick smears prepared with a measured 60 microliter quantity of finger prick blood collected between 8pm-2am. The species of mf will be determined by morphological criteria.
Measured: 4 years
Prevalence of W. bancrofti filarial antigenemia (4 years)
Prevalence of this outcome measure is determined by the percentage (%) of individuals with positive tests for the W. bancrofti filarial antigen. Blood will be tested for filarial antigenemia using the Alere Filariasis Test Strip (FTS).
Measured: 4 years
Secondary outcomes (6)
Prevalence of O. volvulus microfilaria (4 years)
Prevalence of O. volvulus microfilaria (mf) is a binary outcome measured by the presence/absence of O. volvulus mf taken from skin snips using Holth corneoscleral punches taken from the buttocks.
Measured: 4 years
Community egg load of soil transmitted helminth (STH) eggs (4 years)
Community egg load is defined as average stool egg count per species. FLOTAC and Kato-Katz (KK) methods will be used to examine a single stool sample from each subject.
Measured: 4 years
Prevalence of W. bancrofti microfilaria (7 years)
Prevalence of W. bancrofti microfilaria (mf) is a binary outcome measured by the presence/absence of W. bancrofti mf in three-line thick smears prepared with a measured 60 microliter quantity of finger prick blood collected between 8pm-2am. The species of mf will be determined by morphological criteria.
Measured: 7 years
Prevalence of W. bancrofti filarial antigenemia (7 years)
Prevalence of this outcome measure is determined by the percentage (%) of individuals with positive tests for the W. bancrofti filarial antigen. Blood will be tested for filarial antigenemia using the Alere Filariasis Test Strip (FTS).
Measured: 7 years
Prevalence of O. volvulus microfilaria (7 years)
Prevalence of O. volvulus microfilaria (mf) is a binary outcome measured by the presence/absence of O. volvulus mf taken from skin snips using Holth corneoscleral punches taken from the buttocks.
Measured: 7 years
Community egg load of soil transmitted helminth (STH) eggs (7 years)
Community egg load is defined as average stool egg count per species. FLOTAC and Kato-Katz (KK) methods will be used to examine a single stool sample from each subject.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionApr 2017
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic FilariasisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 21,862 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary J Weil, MD, Principal investigator, Washington University School of MedicinePeter U Fischer, PhD, Principal investigator, Washington University School of MedicineFatorma K Bolay, PhD, Study director, Liberian Institute of Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905436
- Sponsor's protocol ID
- 201107185
- Acronym
- DOLF-LIBERIA
- Status last verified
- Feb 2022
- First submitted
- 12 Jul 2013
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Liberia
- ClinicalTrials.gov ID
- NCT01905436
- Acronym / sponsor ID
- DOLF-LIBERIA / 201107185
- Keywords
- Filariasis, Onchocerciasis, Albendazole, Ivermectin, STH Soil Transmitted Helminth infections, MDA Mass Drug Administration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,862 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of onchocerciasis in these populations.
- 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.
Detailed description
Lymphatic filariasis (LF) is a deforming and disabling infectious disease that causes elephantiasis and genital deformity (especially hydroceles). The infection affects some 120 million people in 81 countries in tropical and subtropical regions with well over 1 billion people at risk of acquiring the disease [1]. LF is caused by Wuchereria bancrofti and Brugia spp. (B. malayi and B.timori), nematode parasites that are transmitted by mosquitoes. This study is based on the assumption that currently used MDA regimens and schedules are not optimal for achieving elimination of LF. These regimens (either annual Albendazole (Alb) 400 mg plus diethylcarbamazine 6 mg/kg or Alb 400 mg plus Ivermectin (Iver) 200 µg/kg for LF) were introduced more than 10 years ago.
Onchocerciasis ("Oncho") is similar in some ways to LF in that it is a vector-borne nematode parasitic disease that causes severe disability. In contrast to LF, this disease causes blindness and severe skin disease rather than elephantiasis, and it is spread by black flies instead of mosquitoes. O. volvulus adult worms live in subcutaneous nodules while the adult worms of the LF parasites live in lymphatic vessels. O. volvulus adult worms are larger and less sensitive to available drug treatments than those of the species that cause LF and have a longer lifespan (approximately 14 years rather than the estimated 7 years for LF parasites). More effective drugs or dosing schedules for MDA against Oncho could shorten the number of years needed to interrupt Oncho transmission in areas that previously had high disease rates.
Drugs used for LF MDA are also active against soil transmitted helminth infections (STH, e.g., Ascaris, Hookworm, and Trichuris). De-worming campaigns using anthelmintics usually target special groups of the population, such as schoolchildren, and have limited impact on transmission. Treatment of the total population and semiannual treatments may reduce re-infection considerably and will most likely lead to reduced infection densities and infection prevalence rates. Suppression of STH is an important ancillary benefit of MDA programs for filarial infections. Increasingly control programs for filariasis and STH are being integrated with programs for other parasitic diseases such as schistosomiasis. For this reason, participants will also be tested for schistosomiasis.
Purpose: The study aims to compare the effectiveness once yearly (1X) versus twice yearly (2X) mass drug administration (MDA) for the elimination of lymphatic filariasis, onchocerciasis and for control of soil-transmitted helminth infections (intestinal parasites) in large populations. Mass drug administration will be provided by the Liberian Ministry of Health. This project will assess the impact of the government's public health program.
Procedures: Study procedures include collection of finger prick blood that will be tested for microfilariae by microscopy and for serology testing (antigenemia and antibody testing). Skin snips will be collected and examined by microscopy for the presence of Onchocerca microfilariae. Stool samples will be collected for detection of parasitic worm eggs by microscopy. All assays will be performed in Liberia (filarial serology tests, microfilaria testing, stool examinations).
Washington University researchers developed the protocol, will provide training and guidance to Liberian researchers, and work with them to analyze the data. Liberian researchers will consent the participants, obtain blood, skin and stool specimens, perform laboratory tests on the specimens, and enter data on participants and lab results.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Annual Mass Drug Administration | – | Drug: Annual versus Semiannual Albendazole plus Ivermectin Mass Drug AdministrationThis group will receive annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Liberian Ministry of Health. |
| Semiannual Mass Drug Administration | – | Drug: Annual versus Semiannual Albendazole plus Ivermectin Mass Drug AdministrationThis group will receive semi-annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Liberian Ministry of Health. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study populations are people who live in areas of Liberia that are co-endemic for lymphatic filariasis and onchocerciasis.
Key inclusion criteria (2 listed)
- • Study areas should be endemic for filariasis and onchocerciasis.
- • Study population have limited or no prior experience with MDA. Males and Females greater than 5 years of age.
Key exclusion criteria (2 listed)
- • Children less than 5 years of age.
- • Children who weigh less than 15 kg (33 lb)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Annual versus Semiannual Albendazole plus Ivermectin Mass Drug AdministrationAlso: Albenza (Albendazole); Ivermectin, also known as Mectizan or Stromectol.Annual or semiannual Albendazole plus Ivermectin, administered by the Liberian Ministry of Health. | Drug | Annual Mass Drug Administration, Semiannual Mass Drug Administration |
Primary outcome
Prevalence of W. bancrofti microfilaria (4 years)
Time frame: 4 years
Prevalence of W. bancrofti microfilaria (mf) is a binary outcome measured by the presence/absence of W. bancrofti mf in three-line thick smears prepared with a measured 60 microliter quantity of finger prick blood collected between 8pm-2am. The species of mf will be determined by morphological criteria.
Prevalence of W. bancrofti filarial antigenemia (4 years)
Time frame: 4 years
Prevalence of this outcome measure is determined by the percentage (%) of individuals with positive tests for the W. bancrofti filarial antigen. Blood will be tested for filarial antigenemia using the Alere Filariasis Test Strip (FTS).
6 secondary outcomes
Prevalence of O. volvulus microfilaria (4 years)
Time frame: 4 years
Community egg load of soil transmitted helminth (STH) eggs (4 years)
Time frame: 4 years
Prevalence of W. bancrofti microfilaria (7 years)
Time frame: 7 years
Prevalence of W. bancrofti filarial antigenemia (7 years)
Time frame: 7 years
Prevalence of O. volvulus microfilaria (7 years)
Time frame: 7 years
Community egg load of soil transmitted helminth (STH) eggs (7 years)
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Death to Onchocerciasis and Lymphatic Filariasis (DOLF) ProjectLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary J Weil, MD principal investigator
Washington University School of Medicine
Peter U Fischer, PhD principal investigator
Washington University School of Medicine
Fatorma K Bolay, PhD study director
Liberian Institute of Biomedical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphatic Filariasis and Onchocerciasis, run by Washington University School of Medicine at 1 site in Liberia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Liberia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of W. bancrofti microfilaria (4 years) (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.