Efficacy, Acceptability & Cost-effectiveness of Long Lasting Insecticide

Status Completed

Clinical Trial Summary

A cluster-randomized vector control trial in Bihar, India, and neighboring Nepal, will test the efficacy of long-lasting impregnated bednets (LLINs, Permanets) for reducing visceral leishmaniasis incidence. The intervention unit is the village (400-1000 people). The study is designed to detect a 50% reduction in Leishmania donovani incidence in intervention compared to control clusters over 2 years. 24 clusters (selected as high incidence during previous years) will be randomly allocated to intervention or control. Following health education, and with informed consent, all households in intervention villages will receive free Permanets (from September 2006). Net usage will be monitored and new nets provided if required. Control villages will not be given untreated nets, as - although commonly used in this region - their effectiveness against sandflies has not been proven. Pre-intervention infection status of villagers (>2 yrs) will be evaluated serologically from finger-prick blood (and past/current disease status noted). Incident infections will be recorded by 3-monthly active search for clinical cases, and by annual serological diagnoses to detect subclinical infections. All villagers (>2yrs) will be leishmanin skin tested at the end of the trial for further subclinical infection detection, and sera from a sub-sample will be tested for antibodies to sandfly saliva antigens (a measure of sandfly exposure). All clinical cases will be given free treatment. Free Permanets will be provided to control villages after the trial. Complementary studies involve entomological surveillance by light traps in a sample of houses and social/economic questionnaire surveys. The entomological surveys will test whether community-wide use of LLINs provides any mass effect, which could protect those in the community who fail to use LLIN for any reason.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00318721
Study type	Interventional
Source	London School of Hygiene and Tropical Medicine
Contact
Status	Completed
Phase	N/A
Start date	June 2006
Completion date	November 2009

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT02839603` - Asymptomatic Leishmania Infection in HIV Patients
Completed	`NCT00370825` - Combination Chemotherapy for the Treatment of Indian Kala-Azar	Phase 2
Recruiting	`NCT05426577` - Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure
Completed	`NCT01069198` - A Community Trial for Visceral Leishmaniasis (VL)	N/A
Completed	`NCT00371995` - Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar	Phase 2
Completed	`NCT00604955` - Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis	Phase 4
Completed	`NCT01032187` - Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children	Phase 4
Completed	`NCT00342823` - Immunogenetics of Visceral Leishmaniasis	N/A
Completed	`NCT04003532` - LAMP Assay for the Diagnosis of Visceral Leishmaniasis
Terminated	`NCT01980199` - Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan	Phase 2
Completed	`NCT00255567` - Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis	Phase 3
Not yet recruiting	`NCT06118749` - Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study
Recruiting	`NCT04342715` - A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
Completed	`NCT02431143` - Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa	Phase 2
Completed	`NCT01122771` - Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh	Phase 3
Completed	`NCT03636659` - Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition	Phase 1
Not yet recruiting	`NCT01566552` - Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis	Phase 4
Completed	`NCT00696969` - Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis	Phase 3
Completed	`NCT00216346` - Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis	Phase 3
Completed	`NCT02011958` - Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar — KALANET

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms