Longlasting insecticidal nets for prevention of Leishmania donovani infection in India and Nepal: paired cluster randomised trial

Albert Picado; Shri Prakash Singh; Suman Rijal; Shyam Sundar; Bart Ostyn; François Chappuis; Surendra Uranw; Kamlesh Gidwani; Basudha Khanal; Madhukar Rai; Ishwari Sharma Paudel; Murari Lal Das; Rajiv Kumar; Pankaj Srivastava; Jean Claude Dujardin; Veerle Vanlerberghe; Elisabeth Anne Wreford Andersen; Clive Richard Davies; Marleen Boelaert

doi:10.1136/bmj.c6760

Longlasting insecticidal nets for prevention of Leishmania donovani infection in India and Nepal: paired cluster randomised trial

Albert Picado, Shri Prakash Singh, Suman Rijal, Shyam Sundar, Bart Ostyn, François Chappuis, Surendra Uranw, Kamlesh Gidwani, Basudha Khanal, Madhukar Rai, Ishwari Sharma Paudel, Murari Lal Das, Rajiv Kumar, Pankaj Srivastava, Jean Claude Dujardin, Veerle Vanlerberghe, Elisabeth Anne Wreford Andersen, Clive Richard Davies, Marleen Boelaert

Section of Biostatistics

73 Citations (Scopus)

Abstract

To test the effectiveness of large scale distribution of longlasting nets treated with insecticide in reducing the incidence of visceral leishmaniasis in India and Nepal. Paired cluster randomised controlled trial designed to detect a 50% reduction in incidence of Leishmania donovani infection. Villages in Muzaffarpur district in India and Saptari, Sunsari, and Morang districts in Nepal. 13 intervention and 13 control clusters. 12691 people were included in the analysis of the main outcome (infection), and 19810 were enrolled for the secondary (disease) end point. Longlasting insecticidal nets (treated with deltamethrin) were distributed in the intervention clusters in December 2006. Infection was determined by direct agglutination test at 12 and 24 months after the intervention in those who had negative results (titre <1:1600) at baseline. The effect estimate was computed as the geometric mean of the risk ratios for seroconversion for each cluster pair (net/no net), with its 95% confidence interval. Formal tests of effect of no intervention were obtained with a paired t test. There was no significant difference in the risk of seroconversion over 24 months in intervention (5.4%; 347/6372) compared with control (5.5%; 345/6319 people) clusters (risk ratio 0.90, 95% confidence interval 0.49 to 1.65) nor in the risk of clinical visceral leishmaniasis (0.99, 0.46 to 1.40). Adjustment for covariates did not alter these conclusions. There is no evidence that large scale distribution of longlasting insecticidal nets provides additional protection against visceral leishmaniasis compared with existing control practice in the Indian subcontinent. The observed effect was small and not significant, though the confidence intervals did not exclude a 50% change in either direction. Clinical Trials NCT 2005-015374.

Original language	English
Journal	BMJ - British Medical Journal - Clinical Research Edition
Volume	341
Pages (from-to)	c6760
ISSN	0959-8138
DOIs	https://doi.org/10.1136/bmj.c6760
Publication status	Published - Jan 2010

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Picado, A., Singh, S. P., Rijal, S., Sundar, S., Ostyn, B., Chappuis, F., Uranw, S., Gidwani, K., Khanal, B., Rai, M., Paudel, I. S., Das, M. L., Kumar, R., Srivastava, P., Dujardin, J. C., Vanlerberghe, V., Andersen, E. A. W., Davies, C. R., & Boelaert, M. (2010). Longlasting insecticidal nets for prevention of Leishmania donovani infection in India and Nepal: paired cluster randomised trial. BMJ - British Medical Journal - Clinical Research Edition, 341, c6760. https://doi.org/10.1136/bmj.c6760

Longlasting insecticidal nets for prevention of Leishmania donovani infection in India and Nepal: paired cluster randomised trial. / Picado, Albert; Singh, Shri Prakash; Rijal, Suman et al.

In: BMJ - British Medical Journal - Clinical Research Edition, Vol. 341, 01.2010, p. c6760.

Research output: Contribution to journal › Journal article › Research › peer-review

Picado, A, Singh, SP, Rijal, S, Sundar, S, Ostyn, B, Chappuis, F, Uranw, S, Gidwani, K, Khanal, B, Rai, M, Paudel, IS, Das, ML, Kumar, R, Srivastava, P, Dujardin, JC, Vanlerberghe, V, Andersen, EAW, Davies, CR & Boelaert, M 2010, 'Longlasting insecticidal nets for prevention of Leishmania donovani infection in India and Nepal: paired cluster randomised trial', BMJ - British Medical Journal - Clinical Research Edition, vol. 341, pp. c6760. https://doi.org/10.1136/bmj.c6760

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title = "Longlasting insecticidal nets for prevention of Leishmania donovani infection in India and Nepal: paired cluster randomised trial",

abstract = "To test the effectiveness of large scale distribution of longlasting nets treated with insecticide in reducing the incidence of visceral leishmaniasis in India and Nepal. Paired cluster randomised controlled trial designed to detect a 50% reduction in incidence of Leishmania donovani infection. Villages in Muzaffarpur district in India and Saptari, Sunsari, and Morang districts in Nepal. 13 intervention and 13 control clusters. 12691 people were included in the analysis of the main outcome (infection), and 19810 were enrolled for the secondary (disease) end point. Longlasting insecticidal nets (treated with deltamethrin) were distributed in the intervention clusters in December 2006. Infection was determined by direct agglutination test at 12 and 24 months after the intervention in those who had negative results (titre <1:1600) at baseline. The effect estimate was computed as the geometric mean of the risk ratios for seroconversion for each cluster pair (net/no net), with its 95% confidence interval. Formal tests of effect of no intervention were obtained with a paired t test. There was no significant difference in the risk of seroconversion over 24 months in intervention (5.4%; 347/6372) compared with control (5.5%; 345/6319 people) clusters (risk ratio 0.90, 95% confidence interval 0.49 to 1.65) nor in the risk of clinical visceral leishmaniasis (0.99, 0.46 to 1.40). Adjustment for covariates did not alter these conclusions. There is no evidence that large scale distribution of longlasting insecticidal nets provides additional protection against visceral leishmaniasis compared with existing control practice in the Indian subcontinent. The observed effect was small and not significant, though the confidence intervals did not exclude a 50% change in either direction. Clinical Trials NCT 2005-015374.",

author = "Albert Picado and Singh, {Shri Prakash} and Suman Rijal and Shyam Sundar and Bart Ostyn and Fran{\c c}ois Chappuis and Surendra Uranw and Kamlesh Gidwani and Basudha Khanal and Madhukar Rai and Paudel, {Ishwari Sharma} and Das, {Murari Lal} and Rajiv Kumar and Pankaj Srivastava and Dujardin, {Jean Claude} and Veerle Vanlerberghe and Andersen, {Elisabeth Anne Wreford} and Davies, {Clive Richard} and Marleen Boelaert",

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T1 - Longlasting insecticidal nets for prevention of Leishmania donovani infection in India and Nepal: paired cluster randomised trial

AU - Picado, Albert

AU - Singh, Shri Prakash

AU - Rijal, Suman

AU - Sundar, Shyam

AU - Ostyn, Bart

AU - Chappuis, François

AU - Uranw, Surendra

AU - Gidwani, Kamlesh

AU - Khanal, Basudha

AU - Rai, Madhukar

AU - Paudel, Ishwari Sharma

AU - Das, Murari Lal

AU - Kumar, Rajiv

AU - Srivastava, Pankaj

AU - Dujardin, Jean Claude

AU - Vanlerberghe, Veerle

AU - Andersen, Elisabeth Anne Wreford

AU - Davies, Clive Richard

AU - Boelaert, Marleen

PY - 2010/1

Y1 - 2010/1

N2 - To test the effectiveness of large scale distribution of longlasting nets treated with insecticide in reducing the incidence of visceral leishmaniasis in India and Nepal. Paired cluster randomised controlled trial designed to detect a 50% reduction in incidence of Leishmania donovani infection. Villages in Muzaffarpur district in India and Saptari, Sunsari, and Morang districts in Nepal. 13 intervention and 13 control clusters. 12691 people were included in the analysis of the main outcome (infection), and 19810 were enrolled for the secondary (disease) end point. Longlasting insecticidal nets (treated with deltamethrin) were distributed in the intervention clusters in December 2006. Infection was determined by direct agglutination test at 12 and 24 months after the intervention in those who had negative results (titre <1:1600) at baseline. The effect estimate was computed as the geometric mean of the risk ratios for seroconversion for each cluster pair (net/no net), with its 95% confidence interval. Formal tests of effect of no intervention were obtained with a paired t test. There was no significant difference in the risk of seroconversion over 24 months in intervention (5.4%; 347/6372) compared with control (5.5%; 345/6319 people) clusters (risk ratio 0.90, 95% confidence interval 0.49 to 1.65) nor in the risk of clinical visceral leishmaniasis (0.99, 0.46 to 1.40). Adjustment for covariates did not alter these conclusions. There is no evidence that large scale distribution of longlasting insecticidal nets provides additional protection against visceral leishmaniasis compared with existing control practice in the Indian subcontinent. The observed effect was small and not significant, though the confidence intervals did not exclude a 50% change in either direction. Clinical Trials NCT 2005-015374.

AB - To test the effectiveness of large scale distribution of longlasting nets treated with insecticide in reducing the incidence of visceral leishmaniasis in India and Nepal. Paired cluster randomised controlled trial designed to detect a 50% reduction in incidence of Leishmania donovani infection. Villages in Muzaffarpur district in India and Saptari, Sunsari, and Morang districts in Nepal. 13 intervention and 13 control clusters. 12691 people were included in the analysis of the main outcome (infection), and 19810 were enrolled for the secondary (disease) end point. Longlasting insecticidal nets (treated with deltamethrin) were distributed in the intervention clusters in December 2006. Infection was determined by direct agglutination test at 12 and 24 months after the intervention in those who had negative results (titre <1:1600) at baseline. The effect estimate was computed as the geometric mean of the risk ratios for seroconversion for each cluster pair (net/no net), with its 95% confidence interval. Formal tests of effect of no intervention were obtained with a paired t test. There was no significant difference in the risk of seroconversion over 24 months in intervention (5.4%; 347/6372) compared with control (5.5%; 345/6319 people) clusters (risk ratio 0.90, 95% confidence interval 0.49 to 1.65) nor in the risk of clinical visceral leishmaniasis (0.99, 0.46 to 1.40). Adjustment for covariates did not alter these conclusions. There is no evidence that large scale distribution of longlasting insecticidal nets provides additional protection against visceral leishmaniasis compared with existing control practice in the Indian subcontinent. The observed effect was small and not significant, though the confidence intervals did not exclude a 50% change in either direction. Clinical Trials NCT 2005-015374.

U2 - 10.1136/bmj.c6760

DO - 10.1136/bmj.c6760

M3 - Journal article

C2 - 21190965

SN - 0959-8138

VL - 341

SP - c6760

JO - B M J (Clinical Research Edition)

JF - B M J (Clinical Research Edition)

ER -

Longlasting insecticidal nets for prevention of Leishmania donovani infection in India and Nepal: paired cluster randomised trial

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