Lymphatic Filariasis Elimination by Mass Drug AdministrationENBP M&ENCT04124250
East New Britain Province Monitoring & Evaluation
An observational study of Lymphatic Filariasis Elimination by Mass Drug Administration and Monitoring and Evaluation of Mass Drug Administration for Lymphatic Filariasis, run by University Hospitals Cleveland Medical Center at 1 site in Papua New Guinea.
Trial summary
While tremendous progress towards elimination of lymphatic filariasis (LF) has been made in the 20 years since the 1997 Fiftieth World Health Assembly, it is unlikely the goal of eliminating LF as a public health problem by 2020 will be achieved. Read more about this study
- Who is it for?
- Ages 5 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Filariasis Elimination by Mass Drug Administration, Monitoring and Evaluation of Mass Drug Administration for Lymphatic Filariasis, Acceptability of Mass Drug Administration for Lymphatic Filariasis
- What is being tested?
- Observational
- How many people
- 12,930 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- 17 Sep 2019to 1 Jan 2024
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Two distinct age groups will be sampled as part of each assessment: children 5-9 years old and adolescents and adults >10 years. The child and adult surveys will be conducted in the same selected clusters; however, the adult survey will be conducted in a subset of the households (HHs) selected for the child survey because there are likely to be more eligible adults per HH than children.
Who may be able to join
- All individuals ages 5 years to 80 years living in selected villages will be eligible to enroll.
- Must live in the villages for at least 12 months
Who cannot join
- Minors ages 4 and under will not be eligible to enroll.
- Lived in selected village for less than 12 months.
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site
East New Britain Provincial Health Authority
Kokopo, East New Britain Province
About this study
Official title: When is it Appropriate to Stop? Applied Field Research to Develop an M&E Strategy to
While tremendous progress towards elimination of lymphatic filariasis (LF) has been made in the 20 years since the 1997 Fiftieth World Health Assembly, it is unlikely the goal of eliminating LF as a public health problem by 2020 will be achieved. As of 2016, it was estimated that 856 million people are still living in areas with ongoing transmission of LF and require mass drug administration (MDA) [1]. Of the 52 countries that remain endemic and require MDA, 22 (42%) have not started MDA in all endemic implementation units (IUs) [1]. In addition, several countries have found that, despite completing the required number of treatment rounds, the response to the present MDA regimen has been suboptimal in some IUs, requiring additional rounds of MDA.
Read the detailed description
Although the current two-drug regimen has been successful in many places, it is clear that augmented treatment regimens, other alternative strategies, or both are needed to accelerate global elimination. Fortunately, recent scientific studies, led by the DOLF project at Washington University in St. Louis, found that a three-drug regimen, using all three of the medicines typically delivered as a standard two-drug regimen to prevent LF (ivermectin + albendazole or diethycarbamazine + albendazole), is dramatically more effective for achieving sustained clearance of microfilariae from infected persons [2]. WHO conducted a rigorous and thorough review process of data from safety and efficacy trials of the triple drug regimen. In November, 2017, WHO endorsed and provided updated treatment guidelines that endorsed the use of IDA as a MDA regimen for LF elimination programs [3]. Following WHO's formal approval and release of the alternative treatment guidelines, in late November Merck \& Co. committed to increase its Mectizan donation by 100 million treatments annually to eliminate LF [4], making the IDA regimen financially feasible for countries to adopt.
According to the recently published guidelines, WHO recommends the use of annual IDA in settings where onchocerciasis is not co-endemic with LF in districts have not yet started MDA, in areas that have received fewer than 4 effective rounds of MDA, and in areas where MDA results have been suboptimal. These guidelines call for the current epidemiological criteria (<1% microfilaremia or <2% antigenemia) to be applied to sentinel and spot check sites to determine whether the IU is eligible to proceed with the transmission assessment survey (TAS) and for the TAS to be used to base MDA-stopping decisions [3]. While the TAS has proven to be an effective tool for basing stopping decisions under the standard two-drug regimens, it is unclear whether the target age group (6-7 year olds) and epidemiologic target (<2% antigenemia in areas with W. bancrofti and <2% BmR1 antibodies in areas with Brugia spp. infections) are appropriate when IDA is used. Because IDA will result in an accelerated interruption of transmission and because the effects of this regimen on adult worms are not yet fully understood, it is possible that new target populations, infection indicators, sampling strategies, and/or thresholds will be required to determine when it is safe to stop IDA.
The purpose of this protocol is to describe the operational research (OR) that is necessary to develop a set of recommendations for WHO to consider regarding appropriate monitoring and evaluation (M\&E) strategies for countries implementing IDA. Generating the information necessary to establish robust M\&E guidelines requires a significant OR effort to ensure that all relevant information is collected, innovative strategies are considered, and that the ultimate recommendations are supported by evidence across multiple countries. It is important to emphasize that the study design described in this protocol is not what would be recommended of all countries implementing IDA. This protocol is for OR purposes only, with the goal that study findings will lead to a simplified M\&E framework that is feasible for use by national LF elimination programs.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Mass Drug Administration with a single co-administered dose of Ivermectin, DEC and Albendazole performed by Provincial and National Health Departments annually for two years
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the presence of W. bancrofti microfilariae
Perform blood smears of venous blood collected at night
Measured: 3 years
To determine the presence of W. bancrofti circulating antigen
Fingerstick blood will be collected to assess the presence and semi-quantitative levels of circulating filarial antigen using Alere filarial test strips
Measured: 3 years
Secondary outcomes (2)
To determine the presence and frequency anopheline mosquitos infected with lymphatic filariasis (Xenomonitoring)
Mosquitoes will be collected by light traps or human landing catches, anopheline mosquitoes separated, pooled and DNA extracted and the presence of W. bancrofti DNA assessed by PCR
Measured: 3 years
To determine the knowledge and attitudes about lymphatic filariasis and acceptability of the mass drug program for lymphatic filariasis
Prior to mass drug treatment and following treatment randomly selected individuals will be asked to complete a questionnaire and subset of individuals interviewed
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 posted11 Oct 2019
- Study start17 Sep 2019
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lymphatic Filariasis Elimination by Mass Drug AdministrationStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Prospective
- Enrolment
- 12,930 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Washington University School of Medicine, Papua New Guinea Institute of Medical Research, Papua New Guinea ENB Provincial Health Authority, National Department of Health, Papua New Guinea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124250
- Sponsor's protocol ID
- STUDY20191141
- Acronym
- ENBP M&E
- Status last verified
- Nov 2024
- First submitted
- 7 Oct 2019
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fischer PU, King CL, Jacobson JA, Weil GJ. Potential Value of Triple Drug Therapy with Ivermectin, Diethylcarbamazine, and Albendazole (IDA) to Accelerate Elimination of Lymphatic Filariasis and Onchocerciasis in Africa. PLoS Negl Trop Dis. 2017 Jan 5;11(1):e0005163. doi: 10.1371/journal.pntd.0005163. eCollection 2017 Jan. No abstract available.
PubMed 28056015Irvine MA, Stolk WA, Smith ME, Subramanian S, Singh BK, Weil GJ, Michael E, Hollingsworth TD. Effectiveness of a triple-drug regimen for global elimination of lymphatic filariasis: a modelling study. Lancet Infect Dis. 2017 Apr;17(4):451-458. doi: 10.1016/S1473-3099(16)30467-4. Epub 2016 Dec 22.
PubMed 28012943Schmaedick MA, Koppel AL, Pilotte N, Torres M, Williams SA, Dobson SL, Lammie PJ, Won KY. Molecular xenomonitoring using mosquitoes to map lymphatic filariasis after mass drug administration in American Samoa. PLoS Negl Trop Dis. 2014 Aug 14;8(8):e3087. doi: 10.1371/journal.pntd.0003087. eCollection 2014 Aug.
PubMed 25122037Rao RU, Nagodavithana KC, Samarasekera SD, Wijegunawardana AD, Premakumara WD, Perera SN, Settinayake S, Miller JP, Weil GJ. A comprehensive assessment of lymphatic filariasis in Sri Lanka six years after cessation of mass drug administration. PLoS Negl Trop Dis. 2014 Nov 13;8(11):e3281. doi: 10.1371/journal.pntd.0003281. eCollection 2014.
PubMed 25393404Bun K, Mode B, Susapu M, Salo J, Bjerum C, Payne M, Tisch D, Sekihara M, Giorgi E, Weil GJ, Fischer PU, Robinson L, Laman M, King CL. Alternative approaches for monitoring and evaluation of lymphatic filariasis following mass drug treatment with ivermectin, diethylcarbamazine and albendazole in East New Britain Province, Papua New Guinea. PLoS Negl Trop Dis. 2025 Jan 27;19(1):e0012128. doi: 10.1371/journal.pntd.0012128. eCollection 2025 Jan.
PubMed 39869653
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When is it Appropriate to Stop? Applied Field Research to Develop an M&E Strategy to
- ClinicalTrials.gov ID
- NCT04124250
- Acronym / sponsor ID
- ENBP M&E / STUDY20191141
- Conditions
- Lymphatic Filariasis Elimination by Mass Drug Administration, Monitoring and Evaluation of Mass Drug Administration for Lymphatic Filariasis, Acceptability of Mass Drug Administration for Lymphatic Filariasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,930 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Washington University School of Medicine, Papua New Guinea Institute of Medical Research, Papua New Guinea ENB Provincial Health Authority, National Department of Health, Papua New Guinea
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 11 Oct 2019 (actual)
- 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.
While tremendous progress towards elimination of lymphatic filariasis (LF) has been made in the 20 years since the 1997 Fiftieth World Health Assembly, it is unlikely the goal of eliminating LF as a public health problem by 2020 will be achieved. As of 2016, it was estimated that 856 million people are still living in areas with ongoing transmission of LF and require mass drug administration (MDA) [1]. Of the 52 countries that remain endemic and require MDA, 22 (42%) have not started MDA in all endemic implementation units (IUs) [1]. In addition, several countries have found that, despite completing the required number of treatment rounds, the response to the present MDA regimen has been suboptimal in some IUs, requiring additional rounds of MDA.
Detailed description
Although the current two-drug regimen has been successful in many places, it is clear that augmented treatment regimens, other alternative strategies, or both are needed to accelerate global elimination. Fortunately, recent scientific studies, led by the DOLF project at Washington University in St. Louis, found that a three-drug regimen, using all three of the medicines typically delivered as a standard two-drug regimen to prevent LF (ivermectin + albendazole or diethycarbamazine + albendazole), is dramatically more effective for achieving sustained clearance of microfilariae from infected persons [2]. WHO conducted a rigorous and thorough review process of data from safety and efficacy trials of the triple drug regimen. In November, 2017, WHO endorsed and provided updated treatment guidelines that endorsed the use of IDA as a MDA regimen for LF elimination programs [3]. Following WHO's formal approval and release of the alternative treatment guidelines, in late November Merck \& Co. committed to increase its Mectizan donation by 100 million treatments annually to eliminate LF [4], making the IDA regimen financially feasible for countries to adopt.
According to the recently published guidelines, WHO recommends the use of annual IDA in settings where onchocerciasis is not co-endemic with LF in districts have not yet started MDA, in areas that have received fewer than 4 effective rounds of MDA, and in areas where MDA results have been suboptimal. These guidelines call for the current epidemiological criteria (<1% microfilaremia or <2% antigenemia) to be applied to sentinel and spot check sites to determine whether the IU is eligible to proceed with the transmission assessment survey (TAS) and for the TAS to be used to base MDA-stopping decisions [3]. While the TAS has proven to be an effective tool for basing stopping decisions under the standard two-drug regimens, it is unclear whether the target age group (6-7 year olds) and epidemiologic target (<2% antigenemia in areas with W. bancrofti and <2% BmR1 antibodies in areas with Brugia spp. infections) are appropriate when IDA is used. Because IDA will result in an accelerated interruption of transmission and because the effects of this regimen on adult worms are not yet fully understood, it is possible that new target populations, infection indicators, sampling strategies, and/or thresholds will be required to determine when it is safe to stop IDA.
The purpose of this protocol is to describe the operational research (OR) that is necessary to develop a set of recommendations for WHO to consider regarding appropriate monitoring and evaluation (M\&E) strategies for countries implementing IDA. Generating the information necessary to establish robust M\&E guidelines requires a significant OR effort to ensure that all relevant information is collected, innovative strategies are considered, and that the ultimate recommendations are supported by evidence across multiple countries. It is important to emphasize that the study design described in this protocol is not what would be recommended of all countries implementing IDA. This protocol is for OR purposes only, with the goal that study findings will lead to a simplified M\&E framework that is feasible for use by national LF elimination programs.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Two distinct age groups will be sampled as part of each assessment: children 5-9 years old and adolescents and adults >10 years. The child and adult surveys will be conducted in the same selected clusters; however, the adult survey will be conducted in a subset of the households (HHs) selected for the child survey because there are likely to be more eligible adults per HH than children.
Key inclusion criteria (2 listed)
- All individuals ages 5 years to 80 years living in selected villages will be eligible to enroll.
- Must live in the villages for at least 12 months
Key exclusion criteria (2 listed)
- Minors ages 4 and under will not be eligible to enroll.
- Lived in selected village for less than 12 months.
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 |
|---|---|---|
| ObservationalMass Drug Administration with a single co-administered dose of Ivermectin, DEC and Albendazole performed by Provincial and National Health Departments annually for two years | Other | – |
Primary outcome
To determine the presence of W. bancrofti microfilariae
Time frame: 3 years
Perform blood smears of venous blood collected at night
To determine the presence of W. bancrofti circulating antigen
Time frame: 3 years
Fingerstick blood will be collected to assess the presence and semi-quantitative levels of circulating filarial antigen using Alere filarial test strips
2 secondary outcomes
To determine the presence and frequency anopheline mosquitos infected with lymphatic filariasis (Xenomonitoring)
Time frame: 3 years
To determine the knowledge and attitudes about lymphatic filariasis and acceptability of the mass drug program for lymphatic filariasis
Time frame: 2 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 6 Nov 2024.
- Results publication: PubMed 28056015Fischer PU, King CL, Jacobson JA, Weil GJ. Potential Value of Triple Drug Therapy with Ivermectin, Diethylcarbamazine, and Albendazole (IDA) to Accelerate Elimination of Lymphatic Filariasis and Onchocerciasis in Africa. PLoS Negl Trop Dis. 2017 Jan 5;11(1):e0005163. doi: 10.1371/journal.pntd.0005163. eCollection 2017 Jan. No abstract available.
- Results publication: PubMed 28012943Irvine MA, Stolk WA, Smith ME, Subramanian S, Singh BK, Weil GJ, Michael E, Hollingsworth TD. Effectiveness of a triple-drug regimen for global elimination of lymphatic filariasis: a modelling study. Lancet Infect Dis. 2017 Apr;17(4):451-458. doi: 10.1016/S1473-3099(16)30467-4. Epub 2016 Dec 22.
- Results publication: PubMed 25122037Schmaedick MA, Koppel AL, Pilotte N, Torres M, Williams SA, Dobson SL, Lammie PJ, Won KY. Molecular xenomonitoring using mosquitoes to map lymphatic filariasis after mass drug administration in American Samoa. PLoS Negl Trop Dis. 2014 Aug 14;8(8):e3087. doi: 10.1371/journal.pntd.0003087. eCollection 2014 Aug.
- Results publication: PubMed 25393404Rao RU, Nagodavithana KC, Samarasekera SD, Wijegunawardana AD, Premakumara WD, Perera SN, Settinayake S, Miller JP, Weil GJ. A comprehensive assessment of lymphatic filariasis in Sri Lanka six years after cessation of mass drug administration. PLoS Negl Trop Dis. 2014 Nov 13;8(11):e3281. doi: 10.1371/journal.pntd.0003281. eCollection 2014.
- Derived from this study: PubMed 39869653Bun K, Mode B, Susapu M, Salo J, Bjerum C, Payne M, Tisch D, Sekihara M, Giorgi E, Weil GJ, Fischer PU, Robinson L, Laman M, King CL. Alternative approaches for monitoring and evaluation of lymphatic filariasis following mass drug treatment with ivermectin, diethylcarbamazine and albendazole in East New Britain Province, Papua New Guinea. PLoS Negl Trop Dis. 2025 Jan 27;19(1):e0012128. doi: 10.1371/journal.pntd.0012128. eCollection 2025 Jan.
- World Health Organization. Alternative mass drug administration regimens to eliminate lymphatic filariasis. 2017;Link provided by the sponsor.
- Merck Commemorates 30 Years of MECTIZAN® Donation Program Progress \| Merck Newsroom HomeLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Elimination by Mass Drug Administration and Monitoring and Evaluation of Mass Drug Administration for Lymphatic Filariasis, run by University Hospitals Cleveland Medical Center at 1 site in Papua New Guinea.
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 6 Nov 2024. 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 Papua New Guinea. 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?
To determine the presence of W. bancrofti microfilariae (time frame: 3 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?
On the ClinicalTrials.gov record for NCT04124250, which also lists 5 linked publications.
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 6 Nov 2024.