Lymphatic FilariasisDOLF-IndoNCT01905423
Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis
An observational study of Lymphatic Filariasis and Soil Transmitted Helminth Infections, run by Washington University School of Medicine at 1 site in Indonesia.
Trial summary
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. 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, Soil Transmitted Helminth Infections
- What is being tested?
- Albendazole (annual), Diethylcarbamazine (annual) and Albendazole (semiannual)
- How many people
- 17,108 participants
- Where
- 1 siteIndonesia
- Study dates
- May 2011to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Indonesia that are endemic for lymphatic filariasis.
Who may be able to join
- Areas should be endemic for filariasis and have limited or no prior experience with MDA. Males and Females greater than or equal to 5 years of age.
Who cannot join
- Children less than 5 years of age.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
University of Indonesia, Department of Parasitology
Jakarta, Java, 10430
About this study
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):
- Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF).
- Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.
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. 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 mass drug administration (MDA) regimens and schedules are not optimal for achieving elimination of LF. These regimens (either annual Albendazole (Alb) 400 mg plus diethylcarbamazine (DEC) 6 mg/kg or Alb 400 mg plus ivermectin (Iver) 200 µg/kg for LF) were developed more than 10 years ago.
Drugs used for LF MDA are also active against soil transmitted helminth infections (STH, e.g., Ascaris, Hookworm, and Trichuris). De-worming campaigns using anthelminthics usually target special groups of the population, such as schoolchildren, and have limited impact on the 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 prevalences. Suppression of STH is an important ancillary benefit of MDA programs for filarial infections.
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 and for control of soil-transmitted helminths (intestinal parasites) in large populations. Mass drug administration will be provided by the Indonesia Ministry of Health. This project will assess the impact of the public health program.
Procedures: Study procedures include collection of finger prick blood that will be tested for microfilaremia and for serology testing (antigenemia and antibody testing). Stool samples will be collected to detect STH infections. All assays will be performed in Indonesia (filarial serology tests, blood smears for detection of microfilariae (MF), and stool examinations for detection of worm eggs).
Washington University researchers developed the protocol, will provide training and guidance to Indonesian researchers, and work with them to analyze the data. Indonesian researchers will consent the participants, obtain stool and blood specimens, perform laboratory tests on the specimens, and enter data on participants and lab results.
- Being tested
- Albendazole (annual), Diethylcarbamazine (annual), Albendazole (semiannual), Diethylcarbamazine (semiannual)
- Keywords
- Filariasis, Albendazole, Diethylcarbamazine, STH Soil Transmitted Helminths, MDA Mass Drug Administration
- Medical subject headings
- Elephantiasis, Filarial, Filariasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole (annual)Drug
Also called Albenza (Albendazole, also known as ALB)
Albendazole 400 mg pnce annually
Diethylcarbamazine (annual)Drug
Also called Diethylcarbamazine, Also known as DEC, (N, N-diethyl-4-methyl-1-piperazine carboxamide dihydrogen citrate). ATC Code: P02CB02 QP52AH02
Diethylcarbamazine 6 mg/kg once annually
Albendazole (semiannual)Drug
Also called Albenza (Albendazole, also known as ALB)
Albendazole 400 mg twice annually
Diethylcarbamazine (semiannual)Drug
Also called Diethylcarbamazine, Also known as DEC, (N, N-diethyl-4-methyl-1-piperazine carboxamide dihydrogen citrate). ATC Code: P02CB02 QP52AH02
Diethylcarbamazine 6 mg/kg twice annually
| Study group | Role | What they receive |
|---|---|---|
| Paga (annual MDA) | This group includes eligible residents of the village of Paga. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.
Paga received a total of three rounds of MDA over a period of 24 months (once every 12 months). Receives: Drug: Albendazole (annual); Drug: Diethylcarbamazine (annual) | |
| Lewomada (annual MDA) | This group includes eligible residents of the village of Lewomada. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.
Lewomada received a total of three rounds of MDA over a period of 24 months (once every 12 months). Receives: Drug: Albendazole (annual); Drug: Diethylcarbamazine (annual) | |
| Pruda (semiannual MDA) | This group includes eligible residents of the village of Pruda. This cohort will receive twice yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.
Pruda received a total of five rounds of MDA over a period of 24 months (once every 6 months). Receives: Drug: Albendazole (semiannual); Drug: Diethylcarbamazine (semiannual) | |
| Pekalongan (annual MDA) | This group includes the villages of Banyurip Ageng and Jenggot. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.
Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis. Receives: Drug: Albendazole (annual); Drug: Diethylcarbamazine (annual) | |
| Pekalongan (semiannual MDA) | This group includes the villages of Kertoharjo and Pabean. This cohort will receive twice yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.
Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis. Receives: Drug: Albendazole (semiannual); Drug: Diethylcarbamazine (semiannual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood
Microfilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual and semiannual community surveys. Prevalence rates (a measure of the disease rates in the population sampled) are expressed as % positive for microfilaremia (having microfilaria in the blood).
Measured: 3 years
Secondary outcomes (5)
Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests
This outcome is reported as the frequency of participants with positive Brugia Rapid antifilarial antibody tests. Data was only collected at baseline and at year 3 for this outcome measure and no antibody data was collected for the Pekalongan study sites.
Measured: 3 years
Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test
Prevalence of filarial antigenemia (detected with the Binax Filariasis Now card test "ICT" card test) among the population surveyed. Prevalence data are expressed as %.
Measured: 3 years
Prevalence of Ascaris Infection
Prevalence of Ascaris infection is defined by the number of participants with any Ascaris worm eggs present in their stool sample as analyzed with microscopy.
Measured: 2 Years
Prevalence of Hookworm Infection
Prevalence of hookworm infection is defined by the number of participants with any hookworm eggs present in their stool sample as analyzed with microscopy.
Measured: 2 years
Prevalence of Trichuris Infection
Prevalence of trichuris infection is defined by the number of participants with any trichuris worm eggs present in their stool sample as analyzed with microscopy.
Measured: 2 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 startMay 2011
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 17,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Weil, MD, Washington University School of Medicine
- Investigators
- Peter U Fischer, Ph.D., Principal investigator, Washington University School of MedicineGary J Weil, MD, Principal investigator, Washington University School of MedicineTaniawati Supali, Ph.D., Study director, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905423
- Sponsor's protocol ID
- 201103313
- Acronym
- DOLF-Indo
- Status last verified
- Oct 2020
- First submitted
- 11 Apr 2012
- Last updated
- 17 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. 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
- ClinicalTrials.gov ID
- NCT01905423
- Acronym / sponsor ID
- DOLF-Indo / 201103313
- Keywords
- Filariasis, Albendazole, Diethylcarbamazine, STH Soil Transmitted Helminths, MDA Mass Drug Administration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,108 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- May 2011 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Posted 16 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF).
- Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.
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. 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 mass drug administration (MDA) regimens and schedules are not optimal for achieving elimination of LF. These regimens (either annual Albendazole (Alb) 400 mg plus diethylcarbamazine (DEC) 6 mg/kg or Alb 400 mg plus ivermectin (Iver) 200 µg/kg for LF) were developed more than 10 years ago.
Drugs used for LF MDA are also active against soil transmitted helminth infections (STH, e.g., Ascaris, Hookworm, and Trichuris). De-worming campaigns using anthelminthics usually target special groups of the population, such as schoolchildren, and have limited impact on the 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 prevalences. Suppression of STH is an important ancillary benefit of MDA programs for filarial infections.
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 and for control of soil-transmitted helminths (intestinal parasites) in large populations. Mass drug administration will be provided by the Indonesia Ministry of Health. This project will assess the impact of the public health program.
Procedures: Study procedures include collection of finger prick blood that will be tested for microfilaremia and for serology testing (antigenemia and antibody testing). Stool samples will be collected to detect STH infections. All assays will be performed in Indonesia (filarial serology tests, blood smears for detection of microfilariae (MF), and stool examinations for detection of worm eggs).
Washington University researchers developed the protocol, will provide training and guidance to Indonesian researchers, and work with them to analyze the data. Indonesian researchers will consent the participants, obtain stool and blood 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
- 5
| Arm | Type | Receives |
|---|---|---|
| Paga (annual MDA) | – | Drug: Albendazole (annual), Drug: Diethylcarbamazine (annual)This group includes eligible residents of the village of Paga. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Paga received a total of three rounds of MDA over a period of 24 months (once every 12 months). |
| Lewomada (annual MDA) | – | Drug: Albendazole (annual), Drug: Diethylcarbamazine (annual)This group includes eligible residents of the village of Lewomada. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Lewomada received a total of three rounds of MDA over a period of 24 months (once every 12 months). |
| Pruda (semiannual MDA) | – | Drug: Albendazole (semiannual), Drug: Diethylcarbamazine (semiannual)This group includes eligible residents of the village of Pruda. This cohort will receive twice yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Pruda received a total of five rounds of MDA over a period of 24 months (once every 6 months). |
| Pekalongan (annual MDA) | – | Drug: Albendazole (annual), Drug: Diethylcarbamazine (annual)This group includes the villages of Banyurip Ageng and Jenggot. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis. |
| Pekalongan (semiannual MDA) | – | Drug: Albendazole (semiannual), Drug: Diethylcarbamazine (semiannual)This group includes the villages of Kertoharjo and Pabean. This cohort will receive twice yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis. |
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 Indonesia that are endemic for lymphatic filariasis.
Key inclusion criteria (1 listed)
- Areas should be endemic for filariasis and have limited or no prior experience with MDA. Males and Females greater than or equal to 5 years of age.
Key exclusion criteria (1 listed)
- Children less than 5 years of age.
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 |
|---|---|---|
| Albendazole (annual)Also: Albenza (Albendazole, also known as ALB)Albendazole 400 mg pnce annually | Drug | Lewomada (annual MDA), Paga (annual MDA), Pekalongan (annual MDA) |
| Diethylcarbamazine (annual)Also: Diethylcarbamazine, Also known as DEC, (N, N-diethyl-4-methyl-1-piperazine carboxamide dihydrogen citrate). ATC Code: P02CB02 QP52AH02Diethylcarbamazine 6 mg/kg once annually | Drug | Lewomada (annual MDA), Paga (annual MDA), Pekalongan (annual MDA) |
| Albendazole (semiannual)Also: Albenza (Albendazole, also known as ALB)Albendazole 400 mg twice annually | Drug | Pekalongan (semiannual MDA), Pruda (semiannual MDA) |
| Diethylcarbamazine (semiannual)Also: Diethylcarbamazine, Also known as DEC, (N, N-diethyl-4-methyl-1-piperazine carboxamide dihydrogen citrate). ATC Code: P02CB02 QP52AH02Diethylcarbamazine 6 mg/kg twice annually | Drug | Pekalongan (semiannual MDA), Pruda (semiannual MDA) |
Primary outcome
Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood
Time frame: 3 years
Microfilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual and semiannual community surveys. Prevalence rates (a measure of the disease rates in the population sampled) are expressed as % positive for microfilaremia (having microfilaria in the blood).
5 secondary outcomes
Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests
Time frame: 3 years
Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test
Time frame: 3 years
Prevalence of Ascaris Infection
Time frame: 2 Years
Prevalence of Hookworm Infection
Time frame: 2 years
Prevalence of Trichuris Infection
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Death to Onchocerciasis and Lymphatic Filariasis (DOLF)Link 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.
Peter U Fischer, Ph.D. principal investigator
Washington University School of Medicine
Gary J Weil, MD principal investigator
Washington University School of Medicine
Taniawati Supali, Ph.D. study director
Universitas Indonesia
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 Soil Transmitted Helminth Infections, run by Washington University School of Medicine at 1 site in Indonesia.
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 1 inclusion and 1 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 17 Nov 2020. 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 Indonesia. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Microfilaria in Blood as Determined by Microscopy of Participant Blood (time frame: 3 years). 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 17 Nov 2020.