- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04124250
East New Britain Province Monitoring & Evaluation (ENBP M&E)
When is it Appropriate to Stop? Applied Field Research to Develop an M&E Strategy to
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christopher L King, MD Ph.D.
- Phone Number: 216 368 4817
- Email: cxk21@case.edu
Study Contact Backup
- Name: Michael Payne
- Email: michael.payne@case.edu
Study Locations
-
-
East New Britain Province
-
Kokopo, East New Britain Province, Papua New Guinea
- Recruiting
- East New Britain Provincial Health Authority
-
Contact:
- Melinda Susapu, PhD
- Phone Number: +675 7295 6646
- Email: msusapu@gmail.com
-
Contact:
- Benedict Mode, MS
- Email: mode.benedict@gmail.com
-
Principal Investigator:
- Moses Laman, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Minors ages 4 and under will not be eligible to enroll.
- Lived in selected village for less than 12 months.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the presence of W. bancrofti microfilariae
Time Frame: 3 years
|
Perform blood smears of venous blood collected at night
|
3 years
|
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
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the presence and frequency anopheline mosquitos infected with lymphatic filariasis (Xenomonitoring)
Time Frame: 3 years
|
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
|
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
|
Prior to mass drug treatment and following treatment randomly selected individuals will be asked to complete a questionnaire and subset of individuals interviewed
|
2 years
|
Collaborators and Investigators
Publications and helpful links
General 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.
- Irvine 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.
- Schmaedick 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.
- Rao 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. Erratum In: PLoS Negl Trop Dis. 2014 Dec;(12):e3428.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20191141
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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