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

This study has been terminated.
(Introduction of National Mass Drug Administration Campaign and failure to identify appropriate participants.)
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Neil French, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01213576
First received: September 30, 2010
Last updated: February 26, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention
Lymphatic Filariasis
Drug: Albendazole 400mg and ivermectin 200mcg/kg
Drug: Albendazole and ivermectin
Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi, Open Label Study

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Number of Participants Achieving Microfilarial Clearance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Microfilarial Clearance at 24 Months of Follow up [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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


Enrollment: 70
Study Start Date: January 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: albendazole 400mg and ivermectin 200mcg/kg
Annual treatment
Drug: Albendazole 400mg and ivermectin 200mcg/kg
400 mg orally given annually
Drug: Albendazole 400mg and ivermectin 200mcg/kg
Albendazole 400mg and ivermectin 200mcg/kg given twice a year
Active Comparator: Albendazole 800mg and ivermectin 400mcg/kg
Annual treatment
Drug: Albendazole and ivermectin
albendazole 800 mg and ivermectin 400mg orally given annually
Active Comparator: Albendazole 400mg and ivermectin 200mcg/kg
albendazole 400mg and ivermectin 200mcg/kg given twice a year
Drug: Albendazole 400mg and ivermectin 200mcg/kg
400 mg orally given annually
Drug: Albendazole 400mg and ivermectin 200mcg/kg
Albendazole 400mg and ivermectin 200mcg/kg given twice a year
Active Comparator: Albendazole 800mg and ivermectin 400mcg /kg bi-annually
Albendazole 800mg and ivermectin 400mcg/kg given twice a year
Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually
albendazole 800mg and ivermectin 400mcg/kg given twice a year

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non- consenting
  • Pregnancy or lactation
  • Treatment with albendazole or ivermectin within the previous 6 months
  • Known allergy to the study drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213576

Locations
Malawi
Karonga Prevention Study
Karonga, Malawi
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Emory University
Investigators
Principal Investigator: Neil French, MB ChB PHD London School of Hygiene and Tropical Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Neil French, Reader In Infectious Disease Epidemiology/Director KPS, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01213576     History of Changes
Other Study ID Numbers: FED-311207
Study First Received: September 30, 2010
Results First Received: February 10, 2015
Last Updated: February 26, 2015
Health Authority: Malawi: National Health Sciences Research Committee

Keywords provided by London School of Hygiene and Tropical Medicine:
Lymphatic filariasis
microfilaria
Albendazole
ivermectin
human immunodeficiency

Additional relevant MeSH terms:
Elephantiasis
Elephantiasis, Filarial
Filariasis
Helminthiasis
Lymphatic Diseases
Lymphedema
Nematode Infections
Parasitic Diseases
Secernentea Infections
Spirurida Infections
Albendazole
Ivermectin
Anthelmintics
Anti-Infective Agents
Anticestodal Agents
Antimitotic Agents
Antineoplastic Agents
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on February 27, 2015