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Lymphatic FilariasisNCT02032043

Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Ivory Coast (DOLF-Ivory Coast)

An observational study of Lymphatic Filariasis and Onchocerciasis, run by Washington University School of Medicine at 1 site in Côte d’Ivoire.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Approximately 4,000 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis and onchocerciasis endemic areas. Subject selection will not be based on health status. Two sites will be studied, and each study will last for 4 years. Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
What is being tested?
Annual versus Semiannual Albendazole plus Ivermectin MDA
How many people
14,457 participants
Where
1 siteCôte d’Ivoire
Study dates
Feb 2014to 4 Dec 2017
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 populations are people who live in areas of Ivory Coast that are co-endemic for lymphatic filariasis and onchocerciasis.

Who may be able to join

  • Study areas should be endemic for filariasis and onchocerciasis.
  • Study population have limited or no prior experience with MDA. Males and Females greater than or equal to 5 years of age.

Who cannot join

  • Children less than 5 years of age.
  • Children who weigh less than 15 kg (33 lb)

Trial locations and contacts

1 site in 1 country.

Côte d’Ivoire1 site
  • Ivory Coast National Program Against Schistosomiasis, Geohelminths and Filariasis

    Abidjan, Lagune-Cocody

Other trials in Côte d’Ivoire

About this study

Official title: Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Ivory Coast

Approximately 4,000 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis and onchocerciasis endemic areas. Subject selection will not be based on health status.

Two sites will be studied, and each study will last for 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study.

Read more

Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic filariasis and onchocerciasis, and investigators will compare the impact of these MDA schedules on soil transmitted helminth infections. MDA will be administered by others (Ivorian Ministry of Health).

The investigators will test the hypothesis that semiannual mass drug administration (MDA) is superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for control of soil transmitted helminth (STH) infections.

  1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF) in these populations.
  2. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of onchocerciasis in these populations.
  3. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.
Read the detailed description

Lymphatic filariasis (LF) is a deforming and disabling infectious disease that causes elephantiasis and genital deformity (especially hydroceles). The infection affects some 120 million people in 81 countries in tropical and subtropical regions with well over 1 billion people at risk of acquiring the disease [1]. LF is caused by Wuchereria bancrofti and Brugia spp. (B. malayi and B.timori), nematode parasites that are transmitted by mosquitoes. This study is based on the assumption that currently used MDA regimens and schedules are not optimal for achieving elimination of LF. These regimens (either annual Albendazole (Alb) 400 mg plus diethylcarbamazine 6 mg/kg or Alb 400 mg plus Ivermectin (Iver) 200 µg/kg for LF) were introduced more than 10 years ago.

Onchocerciasis ("Oncho") is similar in some ways to LF in that it is a vector-borne nematode parasitic disease that causes severe disability. In contrast to LF, this disease causes blindness and severe skin disease rather than elephantiasis, and it is spread by black flies instead of mosquitoes. O. volvulus adult worms live in subcutaneous nodules while the adult worms of the LF parasites live in lymphatic vessels. O. volvulus adult worms are larger and less sensitive to available drug treatments than those of the species that cause LF and have a longer lifespan (approximately 14 years rather than the estimated 7 years for LF parasites). More effective drugs or dosing schedules for MDA against Oncho could shorten the number of years needed to interrupt Oncho transmission in areas that previously had high disease rates.

Drugs used for LF MDA are also active against soil transmitted helminth infections (STH, e.g., Ascaris, Hookworm, and Trichuris). De-worming campaigns using anthelmintics usually target special groups of the population, such as schoolchildren, and have limited impact on transmission. Treatment of the total population and semiannual treatments may reduce re-infection considerably and will most likely lead to reduced infection densities and infection prevalence rates. Suppression of STH is an important ancillary benefit of MDA programs for filarial infections. Increasingly control programs for filariasis and STH are being integrated with programs for other parasitic diseases such as schistosomiasis. For this reason, participants will also be tested for schistosomiasis.

Purpose: The study aims to compare the effectiveness once yearly (1X) versus twice yearly (2X) mass drug administration (MDA) for the elimination of lymphatic filariasis, onchocerciasis and for control of soil-transmitted helminth infections (intestinal parasites) in large populations. Mass drug administration will be provided by the Ivory Coast Ministry of Health. This project will assess the impact of the government's public health program.

Procedures: Study procedures include collection of finger prick blood that will be tested for microfilariae by microscopy and for serology testing (antigenemia and antibody testing). Skin snips will be collected and examined by microscopy for the presence of Onchocerca microfilariae. Stool samples will be collected for detection of parasitic worm eggs by microscopy. All assays will be performed in Ivory Coast(filarial serology tests, microfilaria testing, stool examinations).

Washington University researchers developed the protocol, will provide training and guidance to Ivorian researchers, and work with them to analyze the data. Ivorian researchers will consent the participants, obtain blood, skin and stool specimens, perform laboratory tests on the specimens, and enter data on participants and lab results.

Being tested
Annual versus Semiannual Albendazole plus Ivermectin MDA
Keywords
Filariasis, Onchocerciasis, Albendazole, Ivermectin, STH Soil Transmitted Helminth infections, MDA Mass Drug Administration
Medical subject headings
Elephantiasis, Filarial, Onchocerciasis, Infections, Filariasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Annual versus Semiannual Albendazole plus Ivermectin MDADrug

    Also called Albenza (Albendazole); Mectizan (Ivermectin)

    Annual or semiannual Albendazole plus Ivermectin, administered by the Ivorian Ministry of Health.

Study groups in NCT02032043
Study groupRoleWhat they receive
Annual MDA treated GroupThis group will receive annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Ivorian Ministry of Health.
Receives: Drug: Annual versus Semiannual Albendazole plus Ivermectin MDA
Semiannual Mass Drug AdministrationThis group will receive semi-annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Ivorian Ministry of Health.
Receives: Drug: Annual versus Semiannual Albendazole plus Ivermectin MDA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microfilaria prevalence based on results of microscopic examination of blood smears and skin snips.

    From annual population based surveys, the prevalence of microfilaremia (filarial parasites in the blood or skin snips) will be assessed by microscopic examination of slides with thick blood smears and skin snips. Test results for individuals are either positive or negative. The unit for prevalence studies is the percentage (%) of individuals with positive tests.

    Measured: 4 years

Secondary outcomes (1)
  1. Prevalence of filarial antigenemia in blood and intensity of filarial and intestinal worm infections based on results of microscopy.

    Secondary outcomes for the study include prevalence of filarial antigenemia (detected with the Alere Filariasis Strip test) and prevalence of worm eggs in stool detected by the Kato-Katz test. Both of these outcomes are qualitative with no units of measure (positive or negative). Other secondary outcome measures will be intensity of infection by counting microfilaria (Mf) in blood (Mf per ml of blood) and counting Mf in skin (Mf per milligram) and by counting worm eggs (eggs per gram of stool, assessed separately for each parasite species). All of these quantitative assessments are based on counting parasites by microscopy.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completion4 Dec 2017
  4. Study completion4 Dec 2017

Resources

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
14,457 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02032043
Sponsor's protocol ID
201306100
Status last verified
May 2018
First submitted
7 Jan 2014
Last updated
4 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • Loukouri A, Meite A, Koudou BG, Goss CW, Lew D, Weil GJ, N'Goran EK, Fischer PU. Impact of annual and semi-annual mass drug administration for Lymphatic Filariasis and Onchocerciasis on Hookworm Infection in Cote d'Ivoire. PLoS Negl Trop Dis. 2020 Sep 25;14(9):e0008642. doi: 10.1371/journal.pntd.0008642. eCollection 2020 Sep.

    PubMed 32976514

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphatic Filariasis and Onchocerciasis, run by Washington University School of Medicine at 1 site in Côte d’Ivoire.

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 4 May 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 Côte d’Ivoire. 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?

Microfilaria prevalence based on results of microscopic examination of blood smears and skin snips. (time frame: 4 years). 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 NCT02032043, 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 4 May 2018.

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