Replacement of Insecticides to Control Visceral Leishmaniasis (VL)

NCT01644682 | Completed Phase 3 DMC

• 1 other identifier: PR-11045
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal

Keywords

Visceral leishmaniasis; insecticide; wall lining; KO TAB123; Household; Kala-azar endemic area

Outcome Measures

Primary Outcomes (1)

• Measurement of efficacy of interventions

  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.

  12 months

Secondary Outcomes (1)

• Estimation of intervention costs and its acceptability

  12 months

Study Arms (4)

Arm-1

EXPERIMENTAL

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

Arm-2

EXPERIMENTAL

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

Arm-3

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

IWFPL OTHER

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

Also known as: Insecticide

Arm-1

IDWL OTHER

Install durable wall lining containing deltamethrin to kill immature stage and as well as adult sand flies

Also known as: Insecticide

Arm-2

ITN OTHER

Impregnation of existing bed-nets available in the community with slow release insecticide, deltamethrin

Also known as: Insecticide

Arm-3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Household head who agree to participate in the study

You may not qualify if:

• Household head who does not agree to participate in the study

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Rajendra Memorial Research Institute of Medical Sciences: collaborator
• B.P. Koirala Institute of Health Sciences: collaborator
• Directorate General of Health Services, GoB: collaborator

Study Sites (1)

Godagari

Rajshahi, 6205, Bangladesh

Location

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

Insecticides

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Pesticides; Agrochemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Toxic Actions

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 29, 2017

Record last verified: 2012-07

Locations

BA (1)