Improved Case Detection and Vector Control for Visceral Leishmaniasis

NCT03269006 | Completed DMC

• 1 other identifier: PR-14087
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

Visceral leishmaniasis (VL) also known as kala-azar is a public health problem in Bangladesh. Since 2005 a national kala-azar elimination program is going on in the country. The program has preparatory, attack, consolidation and maintenance phases. The target of the program is to reduce the VL incidence less than 1 per 10,000 people at upazila (sub-district) level in VL endemic upazilas of the country. The program is heading successfully to its consolidation phase. During attack phase house to house search for VL suspects and also suspects with Post-kala-azar Dermal Leishmaniasis (PKDL) was the tool for early diagnosis of VL and PKDL cases. Indoor residual spraying with insecticide (Deltamethrin) was the method for sand fly control to reduce the transmission of the disease. Since in the consolidation phase the VL case load is many times less than that in the attack phase, house to house search for VL and PKDL cases and IRS for vector control is no more cost-effective for the program. Therefore there is a need for alternative methods for active search of VL and PKDL cases and method for sand fly control, appropriate for the consolidation phase. In the present study the investigators propose to investigate the efficacy of Inesfly 5AIGRNG TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB 123, indoor residual spraying (IRS) with Delthamethrin against a control group Methods: A cluster randomized controlled design to measure sand fly density reduction at intervention household as well as sand fly mortality by entomological methods. Outcome measures/variables: reduction of sand fly density at intervention household and sand fly corrected mortality on intervention surfaces compare to control households/conditions.

Conditions

Visceral Leishmaniasis

Keywords

Visceral leishmaniasis; Vector control; Sand fly,; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Reduction of Vector density (CDC light trap)

  Based on sample size calculation, 18 households from each cluster will be selected randomly for sand fly density measurement at base line and 1,3, 6, 9, 12, 15, 18, 21 and 24 months after intervention

  at base line and 1,3, 6, 9, 12, 15, 18, 21 and 24 months after intervention

Secondary Outcomes (1)

• Corrected sand fly mortality

  at 1,3, 6, 9, 12, 15, 18, 21 and 24 months after intervention

Study Arms (5)

Inesfly Paint

EXPERIMENTAL

Inesfly 5AIGRNG TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%). The formulation is vinyl paint with an aqueous base, with the active ingredients residing within Ca CO3 and resin microcapsules, allowing a gradual release of active ingredients. Microcapsules range from one to several hundred micrometers in size.

Device: Inesfly Paint

IDWL (1m)

EXPERIMENTAL

Install durable wall lining up to one meter from the floor of the intervention room containing deltamethrin to kill immature stage and as well as adult sand flies.

Device: IDWL (1m)

ITN (KO-Tab 123)

EXPERIMENTAL

impregnation of existing bed net by the insecticide tablet, K-O Tab 1-2-3 containing deltamethrin.

Device: ITN (KO-Tab 123)

IRS (Delthamethrin)

EXPERIMENTAL

indoor residual spraying with Delthamethrin in the living rooms

Device: IRS (Delthamethrin)

Control

NO INTERVENTION

without any study interventions

Interventions

Inesfly Paint DEVICE

Inesfly 5AIGRNG TM paint contain Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%). Others intervention such as IRS, ITN and IDWLcontain Delthamethrin

Inesfly Paint

IDWL (1m) DEVICE

Install durable wall lining up to one meter from the floor of the intervention room containing deltamethrin to kill immature stage and as well as adult sand flies

IDWL (1m)

ITN (KO-Tab 123) DEVICE

Impregnation of existing bed net by the insecticide tablet, K-O Tab 1-2-3 containing deltamethrin

ITN (KO-Tab 123)

IRS (Delthamethrin) DEVICE

Indoor residual spraying with Delthamethrin in the living rooms

IRS (Delthamethrin)

Eligibility Criteria

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

You may qualify if:

• Filed Research Assistant will be listed all the study households in the selected study areas.
• Only subjects who agree to participate and freely signed the consent form will be included in the study.

You may not qualify if:

• \- Subjects who will not agree to participate and freely signed the consent form will be included in the study.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Icddr,B Field Site

Mymensingh, Bangladesh

Location

MeSH Terms

Conditions

Leishmaniasis, Visceral

Condition Hierarchy (Ancestors)

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

Study Officials

• Dinesh Mondal, PhD

  Senior Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized control trial will be performed with Inesfly 5AIGRNG TM, commercial available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB 123, indoor residual spraying (IRS) with Delthamethrin vs a control group (study with 5 arms). The study will be carried out in villages located in Mymensingh District. Four high endemic villages will be selected for the study. As per sample size calculation we need minimum 31 households to see the efficacy of the interventions. We will include 50 households for each intervention and 50 for control (No intervention). 18 households from each cluster will be selected randomly for entomological analysis which includes sand fly density measurement at base line and 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after intervention, and WHO Cone bio-assay on the intervention surfaces and the control surfaces at 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after intervention.

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: August 31, 2017
• Study Start: January 1, 2016
• Primary Completion: April 30, 2016
• Study Completion: July 30, 2019
• Last Updated: January 14, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: As per institutional (icddr,b) data sharing policy.
• Access Criteria: As per institutional (icddr,b) data sharing policy.

Locations

BA (1)