Lymphatic FilariasisFEDNCT01213576
Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi
A study testing Albendazole 400mg and ivermectin 200mcg/kg, Albendazole and ivermectin and albendazole 800mg and ivermectin 400mcg/kg bi-annually in people with Lymphatic Filariasis, run by London School of Hygiene and Tropical Medicine at 1 site in Malawi.
Trial summary
Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such programmes is very high and has proven to be a major impediment to the success of programmes in many countries with limited financial… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Filariasis
- What is being tested?
- Albendazole 400mg and ivermectin 200mcg/kg, Albendazole and ivermectin and albendazole 800mg and ivermectin 400mcg/kg bi-annually
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMalawi
- Study dates
- Jan 2009to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- understand and sign informed consent
- willing to undergo night blood sampling every 6 months for 2 years
- Age 18 to 55 years
- Haemoglobin of equal or above 9g/dl
- Microfilarial level of equal or above 80mg/dl
Who cannot join
- Non- consenting
- Pregnancy or lactation
- Treatment with albendazole or ivermectin within the previous 6 months
- Known allergy to the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi, Open Label Study
Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such programmes is very high and has proven to be a major impediment to the success of programmes in many countries with limited financial resources.
Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. It is essential to determine whether such higher doses are indeed beneficial since this could have far-reaching effects on the conduct and management of the main mass treatment programmes and also in the management of programmes as they near elimination.
Read the detailed description
The proposed study will enrol up to 120 volunteers with microfilaremic Wuchereria bancrofti infection who would be randomized to receive standard annual treatment (albendazole 400 mg + ivermectin 200 mcg/kg), annual treatment with an increased dose of albendazole (albendazole 800 mg + ivermectin 200400 mcg/kg) or semi-annual treatment with a standard (albendazole 400 mg + ivermectin 200 mcg/kg), or an increased albendazole dose (albendazole 800 mg + ivermectin 200 400 mcg/kg). Microfilarial levels, as well as measures of adult worm burden (circulating antigen) will be followed every six months for two years to determine whether the higher doses, or more frequent regimens are more effective.
The data obtained would be used, in combination with the data from other similar studies being conducted in Mali and in India to advise the Global Programme for the Elimination of Lymphatic Filariasis (GPELF) on improved methods of treatment both for mass treatment and for the management of problem areas within the global programme.
- Conditions
- Lymphatic Filariasis
- Being tested
- Albendazole 400mg and ivermectin 200mcg/kg, Albendazole and ivermectin, albendazole 800mg and ivermectin 400mcg/kg bi-annually
- Keywords
- Lymphatic filariasis, microfilaria, Albendazole, ivermectin, human immunodeficiency
- Medical subject headings
- Elephantiasis, Filarial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole 400mg and ivermectin 200mcg/kgDrug
400 mg orally given annually
Albendazole and ivermectinDrug
albendazole 800 mg and ivermectin 400mg orally given annually
Albendazole 400mg and ivermectin 200mcg/kgDrug
Albendazole 400mg and ivermectin 200mcg/kg given twice a year
albendazole 800mg and ivermectin 400mcg/kg bi-annuallyDrug
albendazole 800mg and ivermectin 400mcg/kg given twice a year
| Study group | Role | What they receive |
|---|---|---|
| albendazole 400mg and ivermectin 200mcg/kg | Active comparator | Annual treatment Receives: Drug: Albendazole 400mg and ivermectin 200mcg/kg |
| Albendazole 800mg and ivermectin 400mcg/kg | Active comparator | Annual treatment Receives: Drug: Albendazole and ivermectin |
| Albendazole 400mg and ivermectin 200mcg/kg | Active comparator | albendazole 400mg and ivermectin 200mcg/kg given twice a year Receives: Drug: Albendazole 400mg and ivermectin 200mcg/kg |
| Albendazole 800mg and ivermectin 400mcg /kg bi-annually | Active comparator | Albendazole 800mg and ivermectin 400mcg/kg given twice a year Receives: Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Microfilarial Clearance
Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.
Measured: 12 months
Secondary outcomes (1)
Number of Participants With Microfilarial Clearance at 24 Months of Follow up
Microfilaria will be detected using the nucleopore filtration technique and analysed according to the respective treatment arms at the 24 month time point. Microfilarial clearance will be defined by non-detection of microfilaria in the night blood sample
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 posted4 Oct 2010 (estimated)
- Study startJan 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Introduction of National Mass Drug Administration Campaign and failure to identify appropriate participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Neil French, London School of Hygiene and Tropical Medicine
- Investigators
- Neil French, MB ChB PHD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213576
- Sponsor's protocol ID
- FED-311207
- Acronym
- FED
- Status last verified
- Feb 2015
- First submitted
- 30 Sep 2010
- Last updated
- 27 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tafatatha TT, Ngwira BM, Taegtmeyer M, Phiri AJ, Wilson TP, Banda LG, Piston WN, Koole O, Horton J, French N. Randomised controlled clinical trial of increased dose and frequency of albendazole and ivermectin on Wuchereria bancrofti microfilarial clearance in northern Malawi. Trans R Soc Trop Med Hyg. 2015 Jun;109(6):393-9. doi: 10.1093/trstmh/trv027. Epub 2015 Apr 15.
PubMed 25877874
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi, Open Label Study
- ClinicalTrials.gov ID
- NCT01213576
- Acronym / sponsor ID
- FED / FED-311207
- Conditions
- Lymphatic Filariasis
- Keywords
- Lymphatic filariasis, microfilaria, Albendazole, ivermectin, human immunodeficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Introduction of National Mass Drug Administration Campaign and failure to identify appropriate participants.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- Jan 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Posted 27 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such programmes is very high and has proven to be a major impediment to the success of programmes in many countries with limited financial resources.
Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. It is essential to determine whether such higher doses are indeed beneficial since this could have far-reaching effects on the conduct and management of the main mass treatment programmes and also in the management of programmes as they near elimination.
Detailed description
The proposed study will enrol up to 120 volunteers with microfilaremic Wuchereria bancrofti infection who would be randomized to receive standard annual treatment (albendazole 400 mg + ivermectin 200 mcg/kg), annual treatment with an increased dose of albendazole (albendazole 800 mg + ivermectin 200400 mcg/kg) or semi-annual treatment with a standard (albendazole 400 mg + ivermectin 200 mcg/kg), or an increased albendazole dose (albendazole 800 mg + ivermectin 200 400 mcg/kg). Microfilarial levels, as well as measures of adult worm burden (circulating antigen) will be followed every six months for two years to determine whether the higher doses, or more frequent regimens are more effective.
The data obtained would be used, in combination with the data from other similar studies being conducted in Mali and in India to advise the Global Programme for the Elimination of Lymphatic Filariasis (GPELF) on improved methods of treatment both for mass treatment and for the management of problem areas within the global programme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| albendazole 400mg and ivermectin 200mcg/kg | Active comparator | Drug: Albendazole 400mg and ivermectin 200mcg/kgAnnual treatment |
| Albendazole 800mg and ivermectin 400mcg/kg | Active comparator | Drug: Albendazole and ivermectinAnnual treatment |
| Albendazole 400mg and ivermectin 200mcg/kg | Active comparator | Drug: Albendazole 400mg and ivermectin 200mcg/kgalbendazole 400mg and ivermectin 200mcg/kg given twice a year |
| Albendazole 800mg and ivermectin 400mcg /kg bi-annually | Active comparator | Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annuallyAlbendazole 800mg and ivermectin 400mcg/kg given twice a year |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- understand and sign informed consent
- willing to undergo night blood sampling every 6 months for 2 years
- Age 18 to 55 years
- Haemoglobin of equal or above 9g/dl
- Microfilarial level of equal or above 80mg/dl
Key exclusion criteria (4 listed)
- Non- consenting
- Pregnancy or lactation
- Treatment with albendazole or ivermectin within the previous 6 months
- Known allergy to the study drugs
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 |
|---|---|---|
| Albendazole 400mg and ivermectin 200mcg/kg400 mg orally given annually | Drug | Albendazole 400mg and ivermectin 200mcg/kg, albendazole 400mg and ivermectin 200mcg/kg |
| Albendazole and ivermectinalbendazole 800 mg and ivermectin 400mg orally given annually | Drug | Albendazole 800mg and ivermectin 400mcg/kg |
| Albendazole 400mg and ivermectin 200mcg/kgAlbendazole 400mg and ivermectin 200mcg/kg given twice a year | Drug | Albendazole 400mg and ivermectin 200mcg/kg, albendazole 400mg and ivermectin 200mcg/kg |
| albendazole 800mg and ivermectin 400mcg/kg bi-annuallyalbendazole 800mg and ivermectin 400mcg/kg given twice a year | Drug | Albendazole 800mg and ivermectin 400mcg /kg bi-annually |
Primary outcome
Number of Participants Achieving Microfilarial Clearance
Time frame: 12 months
Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.
1 secondary outcome
Number of Participants With Microfilarial Clearance at 24 Months of Follow up
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25877874Tafatatha TT, Ngwira BM, Taegtmeyer M, Phiri AJ, Wilson TP, Banda LG, Piston WN, Koole O, Horton J, French N. Randomised controlled clinical trial of increased dose and frequency of albendazole and ivermectin on Wuchereria bancrofti microfilarial clearance in northern Malawi. Trans R Soc Trop Med Hyg. 2015 Jun;109(6):393-9. doi: 10.1093/trstmh/trv027. Epub 2015 Apr 15.
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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.
Neil French, MB ChB PHD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albendazole 400mg and ivermectin 200mcg/kg, Albendazole and ivermectin and albendazole 800mg and ivermectin 400mcg/kg bi-annually in people with Lymphatic Filariasis, run by London School of Hygiene and Tropical Medicine at 1 site in Malawi.
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 5 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: stopped early, as of the sponsor's last update on 27 Feb 2015. 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 Malawi. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Achieving Microfilarial Clearance (time frame: 12 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 NCT01213576, 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 27 Feb 2015.