An observational study in Lymphatic Filariasis and Soil Transmitted Helminth Infections, sponsored by Washington University School of Medicine. Completed at 1 site in Indonesia. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by Washington University School of Medicine · 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):
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.
42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.
This study's enrollment of 17,108 is above the median of 12,930 across 13 observational studies indexed under Elephantiasis, Filarial.
Browse Elephantiasis, Filarial studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study populations are people who live in areas of Indonesia that are endemic for lymphatic filariasis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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).
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).
Drug: Albendazole (annual) · Drug: Diethylcarbamazine (annual)
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).
Drug: Albendazole (semiannual) · Drug: Diethylcarbamazine (semiannual)
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.
Drug: Albendazole (annual) · Drug: Diethylcarbamazine (annual)
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.
Drug: Albendazole (semiannual) · Drug: Diethylcarbamazine (semiannual)
Albendazole 400 mg pnce annually
Also known as: Albenza (Albendazole, also known as ALB)
Diethylcarbamazine 6 mg/kg once annually
Also known as: Diethylcarbamazine, Also known as DEC, (N, N-diethyl-4-methyl-1-piperazine carboxamide dihydrogen citrate). ATC Code: P02CB02 QP52AH02
Albendazole 400 mg twice annually
Also known as: Albenza (Albendazole, also known as ALB)
Diethylcarbamazine 6 mg/kg twice annually
Also known as: Diethylcarbamazine, Also known as DEC, (N, N-diethyl-4-methyl-1-piperazine carboxamide dihydrogen citrate). ATC Code: P02CB02 QP52AH02
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).
Time frame: 3 years
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.
Time frame: 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 %.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
This was a cross-sectional study. The final end points of the study are measures of community prevalence. Participant involvement in the study ended after each survey period. Participants were not followed across survey periods, but could be and were likely recruited into more than one survey period.
| Milestone | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Started | 4456 | 3297 | 4111 | 2757 | 2487 |
| Baseline | 1443 | 722 | 1033 | 1482 | 1326 |
| Year 1 follow-up | 994 | 846 | 1007 | 1275 | 1161 |
| Year 2 follow-up | 1114 | 858 | 1043 | 0 | 0 |
| Year 3 follow-up | 905 | 871 | 1028 | 0 | 0 |
| Completed | 4456 | 3297 | 4111 | 2757 | 2487 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
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).
| Participants | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Baseline (pre-MDA) | 54 | 36 | 146 | 46 | 45 |
| Year 1 | 11 | 9 | 37 | 28 | 30 |
| Year 2 | 6 | 6 | 15 | 0 | 0 |
| Year 3 | 0 | 3 | 12 | 0 | 0 |
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.
| Participants | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Baseline | 175 | 229 | 297 | 0 | 0 |
| Year 1 | 0 | 168 | 0 | 0 | 0 |
| Year 2 | 0 | 134 | 0 | 0 | 0 |
| Year 3 | 16 | 36 | 37 | 0 | 0 |
Prevalence of filarial antigenemia (detected with the Binax Filariasis Now card test "ICT" card test) among the population surveyed. Prevalence data are expressed as %.
| Participants | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Baseline | 14 | 47 | 235 | 118 | 102 |
| Year 1 | 0 | 12 | 91 | 51 | 63 |
| Year 2 | 2 | 13 | 106 | 0 | 0 |
| Year 3 | 0 | 36 | 72 | 0 | 0 |
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.
| Participants | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Baseline | 88 | 56 | 34 | 19 | 58 |
| Year 1 | 135 | 17 | 7 | 11 | 6 |
| Year 2 | 107 | 18 | 3 | 0 | 0 |
Prevalence of hookworm infection is defined by the number of participants with any hookworm eggs present in their stool sample as analyzed with microscopy.
| Participants | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Baseline | 25 | 226 | 35 | 0 | 0 |
| Year 1 | 118 | 118 | 90 | 0 | 0 |
| Year 2 | 65 | 97 | 87 | 0 | 0 |
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.
| Participants | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Baseline | 68 | 45 | 8 | 120 | 352 |
| Year 1 | 93 | 25 | 8 | 35 | 65 |
| Year 2 | 84 | 23 | 13 | 0 | 0 |
Collected over Subjects will be monitored for adverse events related to blood collection at each year of observation.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paga (Annual MDA) | 0/4,456 (0%) | 0/4,456 (0%) | 0/4,456 (0%) |
| Lewomada (Annual MDA) | 0/3,297 (0%) | 0/3,297 (0%) | 0/3,297 (0%) |
| Pruda (Semiannual MDA) | 0/4,111 (0%) | 0/4,111 (0%) | 0/4,111 (0%) |
| Pekalongan (Annual MDA) | 0/2,757 (0%) | 0/2,757 (0%) | 0/2,757 (0%) |
| Pekalongan (Semiannual MDA) | 0/2,487 (0%) | 0/2,487 (0%) | 0/2,487 (0%) |
The Number of Baseline Participants that is reported is actually the total number of participants surveyed before the first round of treatment. This is a cross-sectional study. The Pekalongan study site was dropped from further study following the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections.
| Age, Customized(Participants) | Annual MDA Treated Group (Paga) | Annual MDA Treated Group (Lewomada) | Semiannual MDA Treated Group | Annual MDA Treated Group (Pekalongan) | Semiannual MDA Treated Group (Pekalongan) | Total |
|---|---|---|---|---|---|---|
| Age at Baseline (pre-MDA) — 15 years and younger | 597 | 285 | 374 | 353 | 372 | 1981 |
| Age at Baseline (pre-MDA) — Older than 15 | 794 | 437 | 653 | 1129 | 954 | 3967 |
| Age at Baseline (pre-MDA) — Age unknown | 52 | 0 | 6 | 0 | 0 | 58 |
| Sex/Gender, Customized(Participants) | Annual MDA Treated Group (Paga) | Annual MDA Treated Group (Lewomada) | Semiannual MDA Treated Group | Annual MDA Treated Group (Pekalongan) | Semiannual MDA Treated Group (Pekalongan) | Total |
|---|---|---|---|---|---|---|
| Gender at Baseline (pre-MDA) — Females | 897 | 411 | 545 | 816 | 721 | 3390 |
| Gender at Baseline (pre-MDA) — Males | 546 | 311 | 488 | 666 | 605 | 2616 |
| Gender at Baseline (pre-MDA) — Gender unknown | 0 | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2011 to primary completion in Mar 2015, 46 months.
Results were first posted in Oct 2017, 2 years 7 months after primary completion.
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