Lymphatic FilariasesNCT03131401
Prevalence of LF Infection in Districts Not Included in LF Control Activities
An observational study of Lymphatic Filariases and Onchocerciasis, run by Noguchi Memorial Institute for Medical Research at 1 site in Ghana.
Trial summary
Lymphatic filariasis is a neglected tropical disease earmarked for elimination as a public health problem by the year 2020. Since the year 2000, the Global Program for the Elimination of LF has together with endemic countries undertaken preventive chemotherapy in endemic districts to entire at risk populations. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Lymphatic Filariases, Onchocerciasis
- What is being tested?
- Diagnosis of lymphatic filariasis, Diagnosis of lymphatic Filariasis and onchocerciasis and DEC Patch
- How many people
- 3,736 participants
- Where
- 1 siteGhana
- Study dates
- 21 Jan 2018to 30 Aug 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
- Child, Adult, Older adult
Study population: The study will be conducted in districts considered non-endemic for LF based on the Ghana wide LF mapping conducted in 2000, but where LF cases have been identified. These districts fall within the Eastern and Volta Regions. At least one district has been selected in each of these regions. The selected study districts are East Akim, Hohoe and Adaklu. East Akim and Hohoe districts are also endemic for onchocerciasis.
Who may be able to join
- Willingness to provide informed consent (or assent with parental/guardian consent)
- Age ≥ 5 years
- Residency in the study villages since birth or for at least the previous five years
Who cannot join
- Inability to come out of bed
- Feeling sick
- Inability to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Prevalence of LF Infection in Districts Not Included in LF Control Activities and of the Basis for Integrated Implementation of LF - Onchocerciasis Elimination Strategies in Potentially Co-endemic Areas
Lymphatic filariasis is a neglected tropical disease earmarked for elimination as a public health problem by the year 2020. Since the year 2000, the Global Program for the Elimination of LF has together with endemic countries undertaken preventive chemotherapy in endemic districts to entire at risk populations. In Ghana, treatment of LF is based on the drugs Ivermectin and Albendazole. Remarkable achievements have been made towards the control and elimination of LF in Ghana. However, there remain programmatic and implementation challenges that need to be addressed in order to ensure that the gains made over the last 15 years are sustained. Among these challenges is the persistent transmission of LF in some districts despite more than 10 years of MDA.
Furthermore, LF cases have been identified in communities from eight districts, previously considered as non-endemic. The extent of endemicity in these new districts is unknown. In order to achieve the 2020 elimination targets, it is crucial to determine the distribution and infection prevalence of LF in these districts. Evaluating these districts for LF endemicity will help the implementation of appropriate strategies towards achieving the 2020 target.
Read more
This protocol describes the surveys to be undertaken in Ghana in 3 of these districts. The current standard mapping methodologies of LF have the potential to miss LF endemic villages, due to the focal nature of LF. As such, in order to enhance the chances to detect endemic communities, this survey will use a combination of the WHO EPI cluster survey and current LF mapping protocols. 15 communities will be selected in each district, with 100 survey participants per community. Survey participants will be screened for LF infection using immunological and parasitological methods. Study participants will also be tested for onchocerciasis infection using immunological and parasitological methods in districts where LF and oncho are co-endemic. The information from this survey will be combined with the data on the LF vectors and their infection status in the survey areas and relevant data available at the Ghana Health Service to:
- determine whether LF intervention strategies are indicated in these three districts,
- design, as indicated, appropriate intervention strategies to achieve LF elimination in these three districts by 2020
- inform, if indicated, co-implementation of control, monitoring and evaluation for LF and onchocerciasis in the two onchocerciasis endemic districts
- extract lessons learnt for the design and implementation of surveys in the other districts currently considered non-endemic but where LF cases have been reported.
New rapid diagnostic tests have been developed to assess infection Lf and onchocerciasis infection prevalence at the time of the decision to stop MDA and for surveillance for new infections once MDA has been stopped. These include Rapid Diagnostic Tests (RDT) for antibodies against the W. bancrofti antigen WB123 and the O. volvulus antigen Ov16. These tests still require large scale field validation. Provided additional funding becomes available, this survey will be used to obtain field validation data.
- Conditions
- Lymphatic Filariases, Onchocerciasis
- Being tested
- Diagnosis of lymphatic filariasis, Diagnosis of lymphatic Filariasis and onchocerciasis, DEC Patch
- Medical subject headings
- Elephantiasis, Filarial, Onchocerciasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of lymphatic filariasisDiagnostic test
Also called Filaria Test Strip, Wb123 RDT
Field validation of the diagnostic performance of diagnostic tests for infection with W. bancrofti.
Diagnosis of lymphatic Filariasis and onchocerciasisDiagnostic test
Also called Wb123-Ov16 RDT
Field validation of the diagnostic performance of diagnostic tests for infection with both W. bancrofti and O. volvulus.
DEC PatchDiagnostic test
Also called Diagnosis of onchocerciasis
Field validation of the diagnostic performance of diagnostic tests for infection with O. volvulus.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of lymphatic Filariasis
To determine the prevalence and distribution of LF infection in three districts previously considered non-endemic but reporting LF cases
Measured: 3 months
Measures of protection
To determine what measures the population in these districts use to protect themselves from mosquito bites
Measured: 3 months
Prevalence on Onchocerciasis
To determine the prevalence and intensity of infection with O. volvulus in two of these three districts known to be onchocerciasis endemic
Measured: 3 months
Vectors of lymphatic Filariasis
To determine the LF vectors in three districts considered non-endemic for LF
Measured: 6 months
Wuchereria bancrofti infection in vectors
To assess the prevalence of W. bancrofti infection in mosquitoes in these districts.
Measured: 12 months
Secondary outcomes (1)
Performance of diagnostic tests
To characterize the diagnostic performance via the standard parameters sensitivity and specificity of different diagnostic tests
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start21 Jan 2018
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic FilariasesStudies of the same condition, open and under way.
- 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
- 3,736 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noguchi Memorial Institute for Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ghana Health Service, Neglected Tropical Diseases Program
- Responsible party
- Sponsor
- Investigators
- Daniel A Boakye, PhD, Principal investigator, Noguchi Memorial Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131401
- Sponsor's protocol ID
- TDR B40376
- Status last verified
- Oct 2018
- First submitted
- 27 Feb 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Prevalence of LF Infection in Districts Not Included in LF Control Activities and of the Basis for Integrated Implementation of LF - Onchocerciasis Elimination Strategies in Potentially Co-endemic Areas
- ClinicalTrials.gov ID
- NCT03131401
- Acronym / sponsor ID
- TDR B40376
- Conditions
- Lymphatic Filariases, Onchocerciasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,736 participants (actual)
- Lead sponsor
- Noguchi Memorial Institute for Medical ResearchUniversity, hospital or other
- Collaborators
- Ghana Health Service, Neglected Tropical Diseases Program
- Study start
- 21 Jan 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 27 Apr 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.
Lymphatic filariasis is a neglected tropical disease earmarked for elimination as a public health problem by the year 2020. Since the year 2000, the Global Program for the Elimination of LF has together with endemic countries undertaken preventive chemotherapy in endemic districts to entire at risk populations. In Ghana, treatment of LF is based on the drugs Ivermectin and Albendazole. Remarkable achievements have been made towards the control and elimination of LF in Ghana. However, there remain programmatic and implementation challenges that need to be addressed in order to ensure that the gains made over the last 15 years are sustained. Among these challenges is the persistent transmission of LF in some districts despite more than 10 years of MDA.
Furthermore, LF cases have been identified in communities from eight districts, previously considered as non-endemic. The extent of endemicity in these new districts is unknown. In order to achieve the 2020 elimination targets, it is crucial to determine the distribution and infection prevalence of LF in these districts. Evaluating these districts for LF endemicity will help the implementation of appropriate strategies towards achieving the 2020 target.
This protocol describes the surveys to be undertaken in Ghana in 3 of these districts. The current standard mapping methodologies of LF have the potential to miss LF endemic villages, due to the focal nature of LF. As such, in order to enhance the chances to detect endemic communities, this survey will use a combination of the WHO EPI cluster survey and current LF mapping protocols. 15 communities will be selected in each district, with 100 survey participants per community. Survey participants will be screened for LF infection using immunological and parasitological methods. Study participants will also be tested for onchocerciasis infection using immunological and parasitological methods in districts where LF and oncho are co-endemic. The information from this survey will be combined with the data on the LF vectors and their infection status in the survey areas and relevant data available at the Ghana Health Service to:
- determine whether LF intervention strategies are indicated in these three districts,
- design, as indicated, appropriate intervention strategies to achieve LF elimination in these three districts by 2020
- inform, if indicated, co-implementation of control, monitoring and evaluation for LF and onchocerciasis in the two onchocerciasis endemic districts
- extract lessons learnt for the design and implementation of surveys in the other districts currently considered non-endemic but where LF cases have been reported.
New rapid diagnostic tests have been developed to assess infection Lf and onchocerciasis infection prevalence at the time of the decision to stop MDA and for surveillance for new infections once MDA has been stopped. These include Rapid Diagnostic Tests (RDT) for antibodies against the W. bancrofti antigen WB123 and the O. volvulus antigen Ov16. These tests still require large scale field validation. Provided additional funding becomes available, this survey will be used to obtain field validation data.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted in districts considered non-endemic for LF based on the Ghana wide LF mapping conducted in 2000, but where LF cases have been identified. These districts fall within the Eastern and Volta Regions. At least one district has been selected in each of these regions. The selected study districts are East Akim, Hohoe and Adaklu. East Akim and Hohoe districts are also endemic for onchocerciasis.
Key inclusion criteria (3 listed)
- Willingness to provide informed consent (or assent with parental/guardian consent)
- Age ≥ 5 years
- Residency in the study villages since birth or for at least the previous five years
Key exclusion criteria (3 listed)
- Inability to come out of bed
- Feeling sick
- Inability to provide consent
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 |
|---|---|---|
| Diagnosis of lymphatic filariasisAlso: Filaria Test Strip, Wb123 RDTField validation of the diagnostic performance of diagnostic tests for infection with W. bancrofti. | Diagnostic test | – |
| Diagnosis of lymphatic Filariasis and onchocerciasisAlso: Wb123-Ov16 RDTField validation of the diagnostic performance of diagnostic tests for infection with both W. bancrofti and O. volvulus. | Diagnostic test | – |
| DEC PatchAlso: Diagnosis of onchocerciasisField validation of the diagnostic performance of diagnostic tests for infection with O. volvulus. | Diagnostic test | – |
Primary outcome
Prevalence of lymphatic Filariasis
Time frame: 3 months
To determine the prevalence and distribution of LF infection in three districts previously considered non-endemic but reporting LF cases
Measures of protection
Time frame: 3 months
To determine what measures the population in these districts use to protect themselves from mosquito bites
Prevalence on Onchocerciasis
Time frame: 3 months
To determine the prevalence and intensity of infection with O. volvulus in two of these three districts known to be onchocerciasis endemic
Vectors of lymphatic Filariasis
Time frame: 6 months
To determine the LF vectors in three districts considered non-endemic for LF
Wuchereria bancrofti infection in vectors
Time frame: 12 months
To assess the prevalence of W. bancrofti infection in mosquitoes in these districts.
1 secondary outcome
Performance of diagnostic tests
Time frame: 12 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 11 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Daniel A Boakye, PhD principal investigator
Noguchi Memorial Institute for 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 Filariases and Onchocerciasis, run by Noguchi Memorial Institute for Medical Research at 1 site in Ghana.
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 3 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 11 Oct 2018. 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 Ghana. 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?
Prevalence of lymphatic Filariasis (time frame: 3 months). The study lists 5 primary outcomes in all. 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 11 Oct 2018.