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

September 30, 2010
February 26, 2015
January 2009
February 2012   (final data collection date for primary outcome measure)
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.
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
Complete list of historical versions of study NCT01213576 on ClinicalTrials.gov Archive Site
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
Assess effect of study treatment on microfilaria intensity after 2 years of follow-up [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Number of microfilaria/ml of blood (intensity of infection) from each study participant will be determined using the nucleopore filtartion technique and analysed according to the respective treatment arms at the 24 month time point.
Not Provided
Not Provided
 
Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphatic Filariasis
  • Drug: Albendazole 400mg and ivermectin 200mcg/kg
    400 mg orally given annually
  • Drug: Albendazole and ivermectin
    albendazole 800 mg and ivermectin 400mg orally given annually
  • Drug: Albendazole 400mg and ivermectin 200mcg/kg
    Albendazole 400mg and ivermectin 200mcg/kg given twice a year
  • Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually
    albendazole 800mg and ivermectin 400mcg/kg given twice a year
  • Active Comparator: albendazole 400mg and ivermectin 200mcg/kg
    Annual treatment
    Interventions:
    • Drug: Albendazole 400mg and ivermectin 200mcg/kg
    • Drug: Albendazole 400mg and ivermectin 200mcg/kg
  • Active Comparator: Albendazole 800mg and ivermectin 400mcg/kg
    Annual treatment
    Intervention: Drug: Albendazole and ivermectin
  • Active Comparator: Albendazole 400mg and ivermectin 200mcg/kg
    albendazole 400mg and ivermectin 200mcg/kg given twice a year
    Interventions:
    • Drug: Albendazole 400mg and ivermectin 200mcg/kg
    • Drug: Albendazole 400mg and ivermectin 200mcg/kg
  • Active Comparator: Albendazole 800mg and ivermectin 400mcg /kg bi-annually
    Albendazole 800mg and ivermectin 400mcg/kg given twice a year
    Intervention: Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT01213576
FED-311207
No
Neil French, London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
Emory University
Principal Investigator: Neil French, MB ChB PHD London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP