Visceral LeishmaniasisKALANETNCT00318721
Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
A study testing Long Lasting Impregnated Nets (LLIN) in people with Visceral Leishmaniasis and Kala Azar, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visceral Leishmaniasis, Kala Azar
- What is being tested?
- Long Lasting Impregnated Nets (LLIN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2006to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- at least have seen 1 case per year in each of the last 3 years
- An average of at least 1% Incidence rate over the period of past 3 years.
Who cannot join
- Minimum 500 people
- Maximum 2000 people
- Distance between clusters 2000 meters (distance between borders)
- Houses in tola/ward not sprayed (DDT, other) in 2006
- Accessibility
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
- Conditions
- Visceral Leishmaniasis, Kala Azar
- Being tested
- Long Lasting Impregnated Nets (LLIN)
- Keywords
- Leishmania donovani, cluster-randomised control trial, Long Lasting Impregnated Nets, Bednets, Sandflies
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long Lasting Impregnated Nets (LLIN)Device
Distribution of LLIN in selected clusters
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Long Lasting Impregnated Nets (LLIN) |
| control | No intervention | Not described Receives: Device: Long Lasting Impregnated Nets (LLIN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
L. donovani infection
Measured: yearly
Secondary outcomes (1)
Kala Azar cases
Measured: quarterly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visceral LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium, University Hospital, Geneva, Rajendra Memorial Research Institute of Medical Sciences, Institute of Medical Sciences of the Banaras Hindu University, India, International Centre for Diarrhoeal Disease Research, Bangladesh, B.P. Koirala Institute of Health Sciences
- Investigators
- Marleen Boelaert, Dr, Principal investigator, Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), BelgiumClive Davies, Dr., Principal investigator, London School of Hygiene and Tropical MedicineJean Claude Dujardin, Dr, Principal investigator, Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), BelgiumSuman Rijal, Dr., Principal investigator, B.P. Koirala Institute of Heath Sciences, NepalShyam Sundar, Dr, Principal investigator, Institute of Medical Sciences of the Banaras Hindu University, IndiaFrancois Chappuis, Dr., Principal investigator, University Hospital, GenevaBeena Varghese, Dr, Principal investigator, Centre for Health and Population Research (ICDDR,B), Dhaka, BangladeshMarc Coosemans, Dr, Principal investigator, Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318721
- Sponsor's protocol ID
- CT-2005-015374
- Acronym
- KALANET
- Status last verified
- Jun 2009
- First submitted
- 25 Apr 2006
- Last updated
- 4 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Picado A, Das ML, Kumar V, Kesari S, Dinesh DS, Roy L, Rijal S, Das P, Rowland M, Sundar S, Coosemans M, Boelaert M, Davies CR. Effect of village-wide use of long-lasting insecticidal nets on visceral Leishmaniasis vectors in India and Nepal: a cluster randomized trial. PLoS Negl Trop Dis. 2010 Jan 26;4(1):e587. doi: 10.1371/journal.pntd.0000587.
PubMed 20126269
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
- ClinicalTrials.gov ID
- NCT00318721
- Acronym / sponsor ID
- KALANET / CT-2005-015374
- Conditions
- Visceral Leishmaniasis, Kala Azar
- Keywords
- Leishmania donovani, cluster-randomised control trial, Long Lasting Impregnated Nets, Bednets, Sandflies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium, University Hospital, Geneva, Rajendra Memorial Research Institute of Medical Sciences, Institute of Medical Sciences of the Banaras Hindu University, India, International Centre for Diarrhoeal Disease Research, Bangladesh, B.P. Koirala Institute of Health Sciences
- Study start
- Jun 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Long Lasting Impregnated Nets (LLIN) |
| control | No intervention | Device: Long Lasting Impregnated Nets (LLIN) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- at least have seen 1 case per year in each of the last 3 years
- An average of at least 1% Incidence rate over the period of past 3 years.
Key exclusion criteria (5 listed)
- Minimum 500 people
- Maximum 2000 people
- Distance between clusters 2000 meters (distance between borders)
- Houses in tola/ward not sprayed (DDT, other) in 2006
- Accessibility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long Lasting Impregnated Nets (LLIN)Distribution of LLIN in selected clusters | Device | Intervention, control |
Primary outcome
L. donovani infection
Time frame: yearly
1 secondary outcome
Kala Azar cases
Time frame: quarterly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2009.
- Derived from this study: PubMed 20126269Picado A, Das ML, Kumar V, Kesari S, Dinesh DS, Roy L, Rijal S, Das P, Rowland M, Sundar S, Coosemans M, Boelaert M, Davies CR. Effect of village-wide use of long-lasting insecticidal nets on visceral Leishmaniasis vectors in India and Nepal: a cluster randomized trial. PLoS Negl Trop Dis. 2010 Jan 26;4(1):e587. doi: 10.1371/journal.pntd.0000587.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marleen Boelaert, Dr principal investigator
Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium
Clive Davies, Dr. principal investigator
London School of Hygiene and Tropical Medicine
Jean Claude Dujardin, Dr principal investigator
Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long Lasting Impregnated Nets (LLIN) in people with Visceral Leishmaniasis and Kala Azar, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
L. donovani infection (time frame: yearly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00318721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2009.