Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi

NCT01213576 | Terminated Results

• 1 other identifier: FED-311207
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Lymphatic Filariasis

Keywords

Lymphatic filariasis; microfilaria; Albendazole; ivermectin; human immunodeficiency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Participants With Microfilarial Clearance at 24 Months of Follow up

  24 months

Study Arms (4)

albendazole 400mg and ivermectin 200mcg/kg

ACTIVE COMPARATOR

Annual treatment

Drug: Albendazole 400mg and ivermectin 200mcg/kg

Albendazole 800mg and ivermectin 400mcg/kg

ACTIVE COMPARATOR

Annual treatment

Drug: Albendazole and ivermectin

Albendazole 400mg and ivermectin 200mcg/kg

ACTIVE COMPARATOR

albendazole 400mg and ivermectin 200mcg/kg given twice a year

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

Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually

Interventions

Albendazole 400mg and ivermectin 200mcg/kg DRUG

400 mg orally given annually

Albendazole 400mg and ivermectin 200mcg/kg; albendazole 400mg and ivermectin 200mcg/kg

Albendazole and ivermectin DRUG

albendazole 800 mg and ivermectin 400mg orally given annually

Albendazole 800mg and ivermectin 400mcg/kg

albendazole 800mg and ivermectin 400mcg/kg bi-annually DRUG

albendazole 800mg and ivermectin 400mcg/kg given twice a year

Albendazole 800mg and ivermectin 400mcg /kg bi-annually

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Non- consenting
• Pregnancy or lactation
• Treatment with albendazole or ivermectin within the previous 6 months
• Known allergy to the study drugs

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Emory University: collaborator

Study Sites (1)

Karonga Prevention Study

Karonga, Malawi

Location

Related Publications (1)

• 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.

  PMID: 25877874 DERIVED

MeSH Terms

Conditions

Elephantiasis, Filarial

Interventions

Albendazole; Ivermectin

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones

Results Point of Contact

• Title: Professor Neil French
• Organization: University of Liverpool

french@liv.ac.uk

+441517959630

Study Officials

• Neil French, MB ChB PHD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader In Infectious Disease Epidemiology/Director KPS

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 4, 2010
• Study Start: January 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 27, 2015
• Results First Posted: February 27, 2015

Record last verified: 2015-02

Locations

MA (1)