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Introduction of National Mass Drug Administration Campaign and failure to identify appropriate participants.
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| Name | Class |
|---|---|
| Emory University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| albendazole 400mg and ivermectin 200mcg/kg | Active Comparator | Annual treatment |
|
| Albendazole 800mg and ivermectin 400mcg/kg | Active Comparator | Annual treatment |
|
| Albendazole 400mg and ivermectin 200mcg/kg | Active Comparator | albendazole 400mg and ivermectin 200mcg/kg given twice a year |
|
| Albendazole 800mg and ivermectin 400mcg /kg bi-annually | Active Comparator | Albendazole 800mg and ivermectin 400mcg/kg given twice a year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole 400mg and ivermectin 200mcg/kg | Drug | 400 mg orally given annually |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil French, MB ChB PHD | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karonga Prevention Study | Karonga | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25877874 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Albendazole 400mg and Ivermectin 200mcg/kg Annually | Once a year treatment Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral |
| FG001 | Albendazole 800mg and Ivermectin 400mcg/kg Annually |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Albendazole and ivermectin | Drug | albendazole 800 mg and ivermectin 400mg orally given annually |
|
| Albendazole 400mg and ivermectin 200mcg/kg | Drug | Albendazole 400mg and ivermectin 200mcg/kg given twice a year |
|
| albendazole 800mg and ivermectin 400mcg/kg bi-annually | Drug | albendazole 800mg and ivermectin 400mcg/kg given twice a year |
|
Once a year treatment
Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral
| FG002 | Albendazole 400mg and Ivermectin 200mcg/kg Biannually | Twice a year albendazole 400mg and ivermectin 200mcg/kg given twice a year |
| FG003 | Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually | Twice a year Albendazole 800mg and ivermectin 400mcg/kg given twice a year |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Albendazole 400mg and Ivermectin 200mcg/kg Annual | Albendazole 400mg and ivermectin 200mcg/kg: 400 mg orally given once a year |
| BG001 | Albendazole 800mg and Ivermectin 400mcg/kg Annual | Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg orally given once a year |
| BG002 | Albendazole 400mg and Ivermectin 200mcg/kg Biannual | Albendazole 400mg and ivermectin 200mcg/kg given twice a year |
| BG003 | Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual | Albendazole 800mg and ivermectin 400mcg/kg given twice a year |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Microfilarial count /uL | Geometric Mean | Full Range | microfilaria/uL |
| |||||||||||||||
| HIV status | Number | participants |
| ||||||||||||||||
| Eosinophil count | Geometric Mean | Full Range | cells/uL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of participants with non detectable microfilaria at follow up | Posted | Number | participants | 12 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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 | Intention to treat, with last result carried forward in the case of missing visit | Posted | Number | participants | 24 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Albendazole 400mg and Ivermectin 200mcg/kg Annually | Once a year treatment Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral | 0 | 18 | 5 | 18 | ||
| EG001 | Albendazole 800mg and Ivermectin 400mcg/kg Annually | Once a year treatment Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral | 0 | 17 | 7 | 17 | ||
| EG002 | Albendazole 400mg and Ivermectin 200mcg/kg Biannually | Twice a year albendazole 400mg and ivermectin 200mcg/kg given twice a year | 0 | 18 | 6 | 18 | ||
| EG003 | Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually | Twice a year Albendazole 800mg and ivermectin 400mcg/kg given twice a year | 0 | 17 | 4 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment |
| ||
| headache | General disorders | Systematic Assessment |
| ||
| joint pains | General disorders |
| |||
| abdominal pains | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Neil French | University of Liverpool | +441517959630 | french@liv.ac.uk |
| ID | Term |
|---|---|
| D004605 | Elephantiasis, Filarial |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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| Male |
|
Twice a year
Albendazole 800mg and ivermectin 400mcg/kg given twice a year
|
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