NCT01644682

Replacement of Insecticides to Control Visceral Leishmaniasis

Completed Phase 3 Last updated 28 August 2017

What this trial tests

Phase 3 trial testing IWFPL in Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal in 3,600 participants. Completed in 1 December 2014.

Timeline

1 May 2012

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	prevention
Enrollment	3,600
Start date	1 May 2012
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	1 location across Bangladesh

Drugs / interventions tested

• IWFPL
• IDWL
• ITN

Conditions studied

• Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal — all drugs for Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal →

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh — full company profile →

Who can join

Eligibility, any sex, with Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vector and reservoir control for preventing leishmaniasis.
   González U, Pinart M, Sinclair D, Firooz A, et al · · 2015 · cited 37× · PMID 26246011 · DOI 10.1002/14651858.cd008736.pub2
2. Efficacy, Safety and Cost of Insecticide Treated Wall Lining, Insecticide Treated Bed Nets and Indoor Wall Wash with Lime for Visceral Leishmaniasis Vector Control in the Indian Sub-continent: A Multi-country Cluster Randomized Controlled Trial.
   Mondal D, Das ML, Kumar V, Huda MM, et al · · 2016 · cited 24× · PMID 27533097 · DOI 10.1371/journal.pntd.0004932