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Replacement of Insecticides to Control Visceral Leishmaniasis (VL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01644682
First Posted: July 19, 2012
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rajendra Memorial Research Institute of Medical Sciences
B.P. Koirala Institute of Health Sciences
Directorate General of Health Services, GoB
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
  Purpose

Visceral leishmaniasis (VL) is a public health problem in Bangladesh, India and Nepal. To control the disease in these three countries a National kala-azar elimination program is ongoing. One of the major pillars of the elimination program is VL vector control. Currently there is a no public VL vector control program in Bangladesh. In India the program is depending on Indoor Residual Spraying with insecticides. IRS with DDT and in Nepal on Alpha-cypermethrin. The sand fly, vector of VL is already resistant to DDT and hurdles related with IRS i.e. funds, logistics and human resources make IRS unsustainable VL vector control method in Nepal. Thus alternative to IRS for VL vector control is highly desirable for the success of national kala-azar elimination program in these three countries.

Through current research activities we will compare the effectiveness of three effective VL vector control methods. They are 1) Plastering of household walls with lime (a traditional method known in the study areas),treatment of possible sand-fly breeding places with lime and bleaching powder; 2) Installing durable wall lining containing deltamethrin in the main living room(s) of households; 3) Impregnation of existing bed-nets with slow release insecticide tablet containing deltamethrin.

The study finding will be important for the national elimination program of the three countries through discovering the most effective VL vector control method.


Condition Intervention Phase
Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal Other: IWFPL Other: IDWL Other: ITN Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Replacement of Insecticides to Control Visceral Leishmaniasis

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Measurement of efficacy of interventions [ Time Frame: 12 months ]
    Efficacy will be measured by the reduction of sand-fly density by intervention compared to control measured by sand-fly density at 4 weeks, 12 weeks, 24 weeks and 12 months after intervention; percentage mortality of sand-fly assessed by WHO Cone Bioassay test on wall and impregnated net compared to control at 4 weeks, 12 weeks, 24 weeks and 12 months after intervention.


Secondary Outcome Measures:
  • Estimation of intervention costs and its acceptability [ Time Frame: 12 months ]

    Fixed costs (equipment/accessories, apportioned staff salary, non-recurrent training, social mobilization etc.) and variable costs (lime, bleaching powder, K0 tab 123, wall lining, labor charge, transportation, travel cost etc.) data will be collected through projects financial database, household level inventory that received intervention(s), key informant interview with field supervisors/technicians, and record review. Relationship between cost and effectiveness of corresponding intervention(s) will be represented by cost and effectiveness ratio for comparison.

    Acceptability survey will be carried out through structure questionnaire in all the experimental arms. The survey will be conducted at 6 weeks after intervention.



Enrollment: 3600
Study Start Date: May 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm-1
In each country, this arm constitute with 6 clusters where 2 from high, 2 from medium and 2 from low shadfly destiny. Each cluster has 50 households. It will receive IWFPL intervention.
Other: IWFPL
Indoor house walls and floors will be plastered with lime (a traditional method known in the study areas) including treatment of outdoor breeding places with lime and bleaching powder to inhibit sandfly breeding
Other Name: Insecticide
Experimental: Arm-2
In each country, this arm constitute with 6 clusters where 2 from high, 2 from medium and 2 from low shadfly destiny. Each cluster has 50 households. It will receive IDWL intervention.
Other: IDWL
Install durable wall lining containing deltamethrin to kill immature stage and as well as adult sand flies
Other Name: Insecticide
Experimental: Arm-3
In each country, this arm constitute with 6 clusters where 2 from high, 2 from medium and 2 from low shadfly destiny. Each cluster has 50 households. It will receive ITN intervention.
Other: ITN
Impregnation of existing bed-nets available in the community with slow release insecticide, deltamethrin
Other Name: Insecticide
No Intervention: Control
In each country, this arm constitute with 6 clusters where 2 from high, 2 from medium and 2 from low shadfly destiny. Each cluster has 50 households. It will not receive any intervention, Control group

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Household head who agree to participate in the study

Exclusion Criteria:

  • Household head who does not agree to participate in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644682


Locations
Bangladesh
Godagari
Rajshahi, Bangladesh, 6205
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Rajendra Memorial Research Institute of Medical Sciences
B.P. Koirala Institute of Health Sciences
Directorate General of Health Services, GoB
  More Information

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01644682     History of Changes
Other Study ID Numbers: PR-11045
First Submitted: July 17, 2012
First Posted: July 19, 2012
Last Update Posted: August 29, 2017
Last Verified: July 2012

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Visceral leishmaniasis
insecticide
wall lining
KO TAB123
Household
Kala-azar endemic area

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases