Lymphatic FilariasisMDANCT03268252
Optimization of MDA With Existing Drug Regimens for LF: Monitoring Efficacy of Ongoing Treatment Programs in PNG
An observational study of Lymphatic Filariasis, run by University Hospitals Cleveland Medical Center at 1 site in Papua New Guinea.
Trial summary
The standard regimen for elimination of lymphatic filariasis (LF) in PNG is annual administration of two drugs at the same time. The two drugs are called "DEC" (Diethylcarbamazine, 6 mg/kg body weight) and "ALB" (Albendazole 400 mg for all individuals regardless of weight), which are given one time per year for five… 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
- How many people
- 3,200 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- Jun 2012to Dec 2018
- 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 population (3,200/survey) will include male and female subjects >=5 years of age living in East Sepik Province, PNG. If unexpected logistical problems should arise, other study areas have been identified in Madang Province. The proposed study area will be in the Dreikikier Rural Local Level Government (LLG, approx pop 20,000) and Gawanga Rural, LLG (approx pop 13,000). Residents of villages previously treated with MDA will not be included in the study. Children <5 years of age from community studies excluded because prevalence rates for LF tend to be very low in young children and because of difficulties associated with collecting clinical specimens from this population. Pregnancy will not be an exclusion criteria because DEC and ALB are considered safe in pregnancy.
Who may be able to join
- Individuals aged >=5 years of age in the community
- Willingness to give informed consent to participate in the study
- Willingness of parents or guardians to give consent for minors to participate in study
Who cannot join
- 1. Not willing or able to give informed consent for the study
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site
Papua New Guinean Institute for Medical Research
Maprik, Sandaun Province
About this study
Official title: Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis: Monitoring Efficacy of Ongoing Treatment Programs in Papua New Guinea
The standard regimen for elimination of lymphatic filariasis (LF) in PNG is annual administration of two drugs at the same time. The two drugs are called "DEC" (Diethylcarbamazine, 6 mg/kg body weight) and "ALB" (Albendazole 400 mg for all individuals regardless of weight), which are given one time per year for five to seven years with the aim to interrupt transmission that occurs through local mosquito vectors. These drugs kill the larval forms of the parasite in the blood that are necessary for continuing transmission of infection by the mosquito vector. The two drugs were previously thought to have little effect on adult worms, the stage of the parasite which is responsible for production of the larval forms that appear in the blood of infected people. Recent data, however, suggest that DEC and ALB can kill or render adult worms unable to produce the larval forms (sterilization). Therefore, giving these drugs twice per year for three consecutive years may increase the rate of killing or sterilizing of adults worms over regimens that involve administration of the same drugs only one time per year. The overall goal of this research is to compare the anti-parasite activity of DEC plus ALB given one time per year, the current standard for MDA to eliminate LF, to DEC plus ALB given two times per year (at 6-month intervals) in order to reduce the total duration and cost of MDA to eliminate LF in PNG. Adults (18 years and older) and minors (age 5 to 17 years) will be invited to participate in this study. Study participants will be asked to give finger stick blood samples to check LF infection status and stool samples to determine how well the drugs eliminate intestinal worm infections. Sampling will be done by repeated cross-sectional surveys in the same communities, but not necessarily the same persons, one time per year over a 3-year period. As part of the annual treatment infection surveillance the study team will also collect demographic data (place of residence, family relationship, age, use of bed nets), history of swelling of the arms and legs (elephantiasis), scrotal swelling (hydrocele), acute filarial fever accompanied by extremity swelling, and history of prior treatment for LF.
Read the detailed description
This research will conduct a population-based field studies to determine whether the relative cost and efficacy of semi-annual versus annual administration of MDA using DEC (6 mg/kg body weight) plus ALB 400 mg (for all individuals regardless of weight) will be more successful in elimination of LF and reduction in the burden of soil transmitted helminth (worm) infections. The study involving participation of human subjects is observational in nature, uses drugs that are the standard approved treatment for LF in PNG and elsewhere in the Pacific and Asia, and does not involve administration of drugs by the investigators. Diagnosis of LF and administration of anti-LF drugs will be the responsibility of those authorized by the PNG Department of Health to perform this activity.
The study design is repeated cross-sectional surveys examining each subject once. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Approximately 3,200 individuals will participate per year at the beginning of the study and at years 1, 2 and 3 (a total of 4 cross-sectional surveys). The study will include both females and males 5 years of age and older who live in a LF endemic area of PNG. Subject selection will not be based on health status. The study aims to determine the relative impact and cost effectiveness of annual versus twice yearly MDA (DEC 6 mg/kg body plus Alb 400 mg for all individuals) for elimination of LF and reduction in soil transmitted helminthic infection burdens in these populations.
The project is comprised of repeated annual cross-sectional surveys in sentinel communities before and after initiation of MDA for LF. The surveys will be conducted over a period of 3 years at the following times: 0 (pre-treatment baseline), 1, 2, and 3 years corresponding to annual treatment times. Government health officials as part of the GPELF will administer the MDA (standard regimen recommended by WHO is DEC + ALB). Part of the government-sponsored program will be to screen for LF using ICT card screening and finger stick bloods for measuring the density of blood born microfilaria (MF). The current protocol will assist in collection of these data. As part of the annual treatment infection surveillance the study team will also collect demographic data, history of lymphedema, scrotal swelling (hydrocele), acute filarial fever or adenolymphangitis, and history of prior treatment for LF.
- Conditions
- Lymphatic Filariasis
- Medical subject headings
- Elephantiasis, Filarial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2x/year MDA | Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given twice per year | |
| 1x/year MDA | Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once per year |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparator (standard treatment) DEC 6mg/kg + Alb 400mg administered annually (at 0, 12 and 24 months).
Determine if administering DEC 6 mg/kg + ALB 400 mg given twice per year is more effective than standard DEC 6 mg/kg + Alb 400 mg given once per year in achieving reduction of microfilarial prevalence caused by Wuchereria bancrofti infection to less than 1% at 36 months after the initiation of the study.
Measured: 36 months
Secondary outcomes (2)
DEC 6mg/kg + Alb 400 given once
We will test the hypothesis that twice annual MDA is superior to annual MDA for achieving a significantly greater reduction in prevalence and intensity of infection of STH infection infections at 36 months after the initiation of the study
Measured: 36 months
DEC 6 mg/kg + Alb 400 mg + Iver 200 µg/kg administered once only at the beginning of the RCT (0 month).
We will test the hypothesis that twice annual MDA is more cost effective compared to annual MDA for eliminating LF at 36 months.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study startJun 2012
- Primary completionDec 2018
- Study completionDec 2018
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 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research
- Responsible party
- Principal investigator, Christopher L. King, MD, PhD, University Hospitals Cleveland Medical Center
- Investigators
- James W Kazura, MD, Principal investigator, Case Western Reserve UniversityChristopher L King, MD, PhD, Principal investigator, Case Western Reserve UniversityPeter M Siba, PhD, Principal investigator, Papua New Guinea Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268252
- Sponsor's protocol ID
- CWRU Optimization MDA LF PNG
- Acronym
- MDA
- Status last verified
- Apr 2019
- First submitted
- 28 Oct 2013
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. 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: Monitoring Efficacy of Ongoing Treatment Programs in Papua New Guinea
- ClinicalTrials.gov ID
- NCT03268252
- Acronym / sponsor ID
- MDA / CWRU Optimization MDA LF PNG
- Conditions
- Lymphatic Filariasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,200 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research
- Study start
- Jun 2012
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 31 Aug 2017 (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.
The standard regimen for elimination of lymphatic filariasis (LF) in PNG is annual administration of two drugs at the same time. The two drugs are called "DEC" (Diethylcarbamazine, 6 mg/kg body weight) and "ALB" (Albendazole 400 mg for all individuals regardless of weight), which are given one time per year for five to seven years with the aim to interrupt transmission that occurs through local mosquito vectors. These drugs kill the larval forms of the parasite in the blood that are necessary for continuing transmission of infection by the mosquito vector. The two drugs were previously thought to have little effect on adult worms, the stage of the parasite which is responsible for production of the larval forms that appear in the blood of infected people. Recent data, however, suggest that DEC and ALB can kill or render adult worms unable to produce the larval forms (sterilization). Therefore, giving these drugs twice per year for three consecutive years may increase the rate of killing or sterilizing of adults worms over regimens that involve administration of the same drugs only one time per year. The overall goal of this research is to compare the anti-parasite activity of DEC plus ALB given one time per year, the current standard for MDA to eliminate LF, to DEC plus ALB given two times per year (at 6-month intervals) in order to reduce the total duration and cost of MDA to eliminate LF in PNG. Adults (18 years and older) and minors (age 5 to 17 years) will be invited to participate in this study. Study participants will be asked to give finger stick blood samples to check LF infection status and stool samples to determine how well the drugs eliminate intestinal worm infections. Sampling will be done by repeated cross-sectional surveys in the same communities, but not necessarily the same persons, one time per year over a 3-year period. As part of the annual treatment infection surveillance the study team will also collect demographic data (place of residence, family relationship, age, use of bed nets), history of swelling of the arms and legs (elephantiasis), scrotal swelling (hydrocele), acute filarial fever accompanied by extremity swelling, and history of prior treatment for LF.
Detailed description
This research will conduct a population-based field studies to determine whether the relative cost and efficacy of semi-annual versus annual administration of MDA using DEC (6 mg/kg body weight) plus ALB 400 mg (for all individuals regardless of weight) will be more successful in elimination of LF and reduction in the burden of soil transmitted helminth (worm) infections. The study involving participation of human subjects is observational in nature, uses drugs that are the standard approved treatment for LF in PNG and elsewhere in the Pacific and Asia, and does not involve administration of drugs by the investigators. Diagnosis of LF and administration of anti-LF drugs will be the responsibility of those authorized by the PNG Department of Health to perform this activity.
The study design is repeated cross-sectional surveys examining each subject once. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Approximately 3,200 individuals will participate per year at the beginning of the study and at years 1, 2 and 3 (a total of 4 cross-sectional surveys). The study will include both females and males 5 years of age and older who live in a LF endemic area of PNG. Subject selection will not be based on health status. The study aims to determine the relative impact and cost effectiveness of annual versus twice yearly MDA (DEC 6 mg/kg body plus Alb 400 mg for all individuals) for elimination of LF and reduction in soil transmitted helminthic infection burdens in these populations.
The project is comprised of repeated annual cross-sectional surveys in sentinel communities before and after initiation of MDA for LF. The surveys will be conducted over a period of 3 years at the following times: 0 (pre-treatment baseline), 1, 2, and 3 years corresponding to annual treatment times. Government health officials as part of the GPELF will administer the MDA (standard regimen recommended by WHO is DEC + ALB). Part of the government-sponsored program will be to screen for LF using ICT card screening and finger stick bloods for measuring the density of blood born microfilaria (MF). The current protocol will assist in collection of these data. As part of the annual treatment infection surveillance the study team will also collect demographic data, history of lymphedema, scrotal swelling (hydrocele), acute filarial fever or adenolymphangitis, and history of prior treatment for LF.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2x/year MDA | – | –Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given twice per year |
| 1x/year MDA | – | –Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once per year |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population (3,200/survey) will include male and female subjects >=5 years of age living in East Sepik Province, PNG. If unexpected logistical problems should arise, other study areas have been identified in Madang Province. The proposed study area will be in the Dreikikier Rural Local Level Government (LLG, approx pop 20,000) and Gawanga Rural, LLG (approx pop 13,000). Residents of villages previously treated with MDA will not be included in the study. Children <5 years of age from community studies excluded because prevalence rates for LF tend to be very low in young children and because of difficulties associated with collecting clinical specimens from this population. Pregnancy will not be an exclusion criteria because DEC and ALB are considered safe in pregnancy.
Key inclusion criteria (3 listed)
- Individuals aged >=5 years of age in the community
- Willingness to give informed consent to participate in the study
- Willingness of parents or guardians to give consent for minors to participate in study
Key exclusion criteria (1 listed)
- 1. Not willing or able to give informed consent for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The comparator (standard treatment) DEC 6mg/kg + Alb 400mg administered annually (at 0, 12 and 24 months).
Time frame: 36 months
Determine if administering DEC 6 mg/kg + ALB 400 mg given twice per year is more effective than standard DEC 6 mg/kg + Alb 400 mg given once per year in achieving reduction of microfilarial prevalence caused by Wuchereria bancrofti infection to less than 1% at 36 months after the initiation of the study.
2 secondary outcomes
DEC 6mg/kg + Alb 400 given once
Time frame: 36 months
DEC 6 mg/kg + Alb 400 mg + Iver 200 µg/kg administered once only at the beginning of the RCT (0 month).
Time frame: 36 months
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 26 Apr 2019.
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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.
James W Kazura, MD principal investigator
Case Western Reserve University
Christopher L King, MD, PhD principal investigator
Case Western Reserve University
Peter M Siba, PhD principal investigator
Papua New Guinea Institute of Medical 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, 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 3 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 26 Apr 2019. 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?
The comparator (standard treatment) DEC 6mg/kg + Alb 400mg administered annually (at 0, 12 and 24 months). (time frame: 36 months). 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 26 Apr 2019.