Lymphatic FilariasisPhase 4NCT03036059
Twice Yearly Treatment for the Control of LF
A Phase 4 study testing 400 μg/kg Ivermectin + 400 mg Albendazole in people with Lymphatic Filariasis and Helminth Infection, run by Noguchi Memorial Institute for Medical Research at 1 site in Ghana.
Trial summary
The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6 rounds of effective annual Mass Drug Administration (MDA). 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, Helminth Infection
- What is being tested?
- 400 μg/kg Ivermectin + 400 mg Albendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,462 participants
- Where
- 1 siteGhana
- Study dates
- 19 May 2017to 8 Dec 2019
- Phase
- Phase 4
- 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
Who may be able to join
- Residency in the disease endemic community for at least 12 months
- Willingness to provide informed consent/assent
- Willingness to donate blood (per the protocol)
Who cannot join
- Recent residents (<12 months)
- Inability to give informed consent
- Pregnant and lactating women
- Children below the age of 5.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Randomized Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations
The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6 rounds of effective annual Mass Drug Administration (MDA). The treatment regimen is Ivermectin (IVM) in combination with Diethylcarbamazine (DEC) or Albendazole (ALB). In Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many areas, transmission has persisted in some implementation units that had experienced 15 or more rounds of MDA. Alternative intervention strategies, including twice yearly MDA and sleeping under insecticidal nets have significantly accelerated transmission interruption in some settings of high transmission intensity. Thus, it is evident that new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the LF elimination process. This study therefore seeks to test the hypothesis that biannual treatment of LF endemic communities will accelerate interruption of LF transmission.
Two cluster randomized trials will be implemented in LF endemic communities in Ghana. The interventions will be yearly or twice-yearly MDA delivered to entire endemic communities. Allocation to study group will be by clusters identified using the prevalence of LF. Clusters will be randomised to one of two groups: receiving either (1) annual treatment with IVM+ALB; (2) annual MDA with IVM +ALB, followed by an additional MDA 6 months later. The primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys. Entomological assessments will also be undertaken to evaluate the transmission intensity of the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system.
- Conditions
- Lymphatic Filariasis, Helminth Infection
- Being tested
- 400 μg/kg Ivermectin + 400 mg Albendazole
- Keywords
- Twice a year treatment, Biannual treatment, Wuchereria bancrofti
- Medical subject headings
- Elephantiasis, Filarial, Trematode Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 μg/kg Ivermectin + 400 mg AlbendazoleDrug
Also called Mectizan, Stromectol
400ug/Kg, tablet, given orally once or twice a year.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 400 μg/kg Ivermectin + 400 mg Albendazole Tablets given every year for 2 years Receives: Drug: 400 μg/kg Ivermectin + 400 mg Albendazole |
| Expanded frequency group | Experimental | 400 μg/kg Ivermectin + 400 mg Albendazole, Tablets given every 6 months for 2 years Receives: Drug: 400 μg/kg Ivermectin + 400 mg Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline prevalence of Lymphatic Filariasis at 24 months
The primary outcome, the prevalence of LF infection, will be measured through cross-sectional parasitological surveys conducted at baseline and at 24 months. The timing of the final follow-up survey will take into account differences in time since treatment of the annual and biannual treatment groups at 24 months
Measured: 0 and 24 months
Secondary outcomes (3)
Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment
For the secondary outcome, a subsample of individuals from the clusters in each of the study groups will be followed longitudinally for two and half years, in order to better understand the transmission dynamics of LF and to estimate key parameters for mathematical modelling of transmission dynamics and treatment impact.
Measured: 0, 12, 24, 30 months
Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions
A process evaluation, using semi-structured interviews, focus group discussions (FGDs) and a stakeholder analysis, will investigate the community acceptability of the twice-yearly drug administration.
Measured: 24 months
Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions
A process evaluation, using semi-structured interviews, focus group discussions (FGDs) and a stakeholder analysis, will investigate the feasibility of scaling up the twice-yearly drug administration.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start19 May 2017
- Primary completion8 Dec 2019
- Study completion8 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphatic FilariasisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noguchi Memorial Institute for Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ghana Health Services
- Responsible party
- Sponsor
- Investigators
- Dziedzom K de Souza, PhD, Principal investigator, Noguchi Memorial Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036059
- Sponsor's protocol ID
- TMA 2015 CDF - 976
- Status last verified
- Mar 2018
- First submitted
- 3 Nov 2016
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared publicly. Researchers interested in the data can contact the principal investigator directly. No personal identifying information will be shared.
Publications
de Souza DK, Ahorlu CS, Adu-Amankwah S, Otchere J, Mensah SK, Larbi IA, Mensah GE, Biritwum NK, Boakye DA. Community-based trial of annual versus biannual single-dose ivermectin plus albendazole against Wuchereria bancrofti infection in human and mosquito populations: study protocol for a cluster randomised controlled trial. Trials. 2017 Oct 2;18(1):448. doi: 10.1186/s13063-017-2196-9.
PubMed 28969715
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations
- ClinicalTrials.gov ID
- NCT03036059
- Acronym / sponsor ID
- TMA 2015 CDF - 976
- Conditions
- Lymphatic Filariasis, Helminth Infection
- Keywords
- Twice a year treatment, Biannual treatment, Wuchereria bancrofti
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,462 participants (actual)
- Lead sponsor
- Noguchi Memorial Institute for Medical ResearchUniversity, hospital or other
- Collaborators
- Ghana Health Services
- Study start
- 19 May 2017 (actual)
- Primary completion
- 8 Dec 2019 (actual)
- Study completion
- 8 Dec 2019 (actual)
- First posted
- 30 Jan 2017 (estimated)
- 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 Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6 rounds of effective annual Mass Drug Administration (MDA). The treatment regimen is Ivermectin (IVM) in combination with Diethylcarbamazine (DEC) or Albendazole (ALB). In Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many areas, transmission has persisted in some implementation units that had experienced 15 or more rounds of MDA. Alternative intervention strategies, including twice yearly MDA and sleeping under insecticidal nets have significantly accelerated transmission interruption in some settings of high transmission intensity. Thus, it is evident that new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the LF elimination process. This study therefore seeks to test the hypothesis that biannual treatment of LF endemic communities will accelerate interruption of LF transmission.
Two cluster randomized trials will be implemented in LF endemic communities in Ghana. The interventions will be yearly or twice-yearly MDA delivered to entire endemic communities. Allocation to study group will be by clusters identified using the prevalence of LF. Clusters will be randomised to one of two groups: receiving either (1) annual treatment with IVM+ALB; (2) annual MDA with IVM +ALB, followed by an additional MDA 6 months later. The primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys. Entomological assessments will also be undertaken to evaluate the transmission intensity of the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: 400 μg/kg Ivermectin + 400 mg Albendazole400 μg/kg Ivermectin + 400 mg Albendazole Tablets given every year for 2 years |
| Expanded frequency group | Experimental | Drug: 400 μg/kg Ivermectin + 400 mg Albendazole400 μg/kg Ivermectin + 400 mg Albendazole, Tablets given every 6 months for 2 years |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Residency in the disease endemic community for at least 12 months
- Willingness to provide informed consent/assent
- Willingness to donate blood (per the protocol)
Key exclusion criteria (4 listed)
- Recent residents (<12 months)
- Inability to give informed consent
- Pregnant and lactating women
- Children below the age of 5.
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 |
|---|---|---|
| 400 μg/kg Ivermectin + 400 mg AlbendazoleAlso: Mectizan, Stromectol400ug/Kg, tablet, given orally once or twice a year. | Drug | Control group, Expanded frequency group |
Primary outcome
Change from baseline prevalence of Lymphatic Filariasis at 24 months
Time frame: 0 and 24 months
The primary outcome, the prevalence of LF infection, will be measured through cross-sectional parasitological surveys conducted at baseline and at 24 months. The timing of the final follow-up survey will take into account differences in time since treatment of the annual and biannual treatment groups at 24 months
3 secondary outcomes
Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment
Time frame: 0, 12, 24, 30 months
Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions
Time frame: 24 months
Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions
Time frame: 24 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 Feb 2020.
- Derived from this study: PubMed 28969715de Souza DK, Ahorlu CS, Adu-Amankwah S, Otchere J, Mensah SK, Larbi IA, Mensah GE, Biritwum NK, Boakye DA. Community-based trial of annual versus biannual single-dose ivermectin plus albendazole against Wuchereria bancrofti infection in human and mosquito populations: study protocol for a cluster randomised controlled trial. Trials. 2017 Oct 2;18(1):448. doi: 10.1186/s13063-017-2196-9.
- Individual participant dataSharing planned: No. IPD will not be shared publicly. Researchers interested in the data can contact the principal investigator directly. No personal identifying information will be shared.
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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.
Dziedzom K de Souza, 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?
A Phase 4 study testing 400 μg/kg Ivermectin + 400 mg Albendazole in people with Lymphatic Filariasis and Helminth Infection, 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 4 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 Feb 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline prevalence of Lymphatic Filariasis at 24 months (time frame: 0 and 24 months). 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 NCT03036059, which also lists 1 linked publication.
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 Feb 2020.