Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00318721
Other study ID # CT-2005-015374
Secondary ID
Status Completed
Phase N/A
First received April 25, 2006
Last updated November 3, 2009
Start date June 2006
Est. completion date November 2009

Study information

Verified date June 2009
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority Nepal: B.P. Koirala Institute of Health SciencesIndia: Indian Council of Medical Research
Study type Interventional

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.


Recruitment information / eligibility

Status Completed
Enrollment 20000
Est. completion date November 2009
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years and older
Eligibility Inclusion criteria (Clusters):

1. at least have seen 1 case per year in each of the last 3 years

2. An average of at least 1% Incidence rate over the period of past 3 years.

Exclusion criteria (Clusters):

1. Minimum 500 people

2. Maximum 2000 people

3. Distance between clusters 2000 meters (distance between borders)

4. Houses in tola/ward not sprayed (DDT, other) in 2006

5. Accessibility

Study Design

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


Intervention

Device:
Long Lasting Impregnated Nets (LLIN)
Distribution of LLIN in selected clusters

Locations

Country Name City State
India Kala Azar Medical Research Center Muzaffarpur Bihar
Nepal B P Koirala Institute of Health Sciences Dharan

Sponsors (7)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine B.P. Koirala Institute of Health Sciences, Institute of Medical Sciences of the Banaras Hindu University (BHU),India, Institute of Tropical Medicine, Belgium, International Centre for Diarrhoeal Disease Research, Bangladesh, Rajendra Memorial Research Institute of Medical Sciences, University Hospital, Geneva

Countries where clinical trial is conducted

India,  Nepal, 

Outcome

Type Measure Description Time frame Safety issue
Primary L. donovani infection yearly Yes
Secondary Kala Azar cases quarterly No
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 NCT00604955 - Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis Phase 4
Completed NCT00371995 - Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar Phase 2
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