Impact of Insecticide Resistance on Vector Control
This study is currently recruiting participants.
Verified October 2012 by London School of Hygiene and Tropical Medicine
Sponsor:
London School of Hygiene and Tropical Medicine
Collaborators:
Federal Ministry of Health, Sudan
World Health Organization
Liverpool School of Tropical Medicine
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01713517
First received: October 22, 2012
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
The purpose of the study is to determine whether long lasting insecticidal nets and indoor residual insecticide spraying, alone or in combination, are effective for controlling insecticide resistant anopheles mosquitoes for malaria prevention.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria, Falciparum |
Other: Indoor residual insecticide spraying (IRS) Device: Long Lasting Insecticidal Nets (LLIN) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Impact of Insecticide Resistance in Anopheles Arabiensis on the Effectiveness of Malaria Vector Control in Sudan |
Resource links provided by NLM:
Further study details as provided by London School of Hygiene and Tropical Medicine:
Primary Outcome Measures:
- Malaria Incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]Infection with malarial parasites determined by rapid diagnostic tests/microscopy in cohort members who report or have fever (>37.5C)
Secondary Outcome Measures:
- Prevalence of P.falciparum Infection [ Time Frame: 3 years ] [ Designated as safety issue: No ]Infection with plasmodial parasites (falciparum and/or vivax) in randomly selected members of the study cohort in each study cluster during the peak of the malaria transmission season by rapid diagnostic test
- Entomological Innoculation rate [ Time Frame: Average for months Sept, Oct, Nov for years 2011, 2012, 2013 ] [ Designated as safety issue: No ]Anopheles arabiensis mosquitoes collected in sentinel clusters by light trap, window trap, clay pot and pyrethrum sheet collection and determination of sporozoite, human blood index, feeding and resting behaviour.
- Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis [ Time Frame: Yearly average 2011, 2012, 2013, 2014 ] [ Designated as safety issue: No ]Molecular analysis of mosquito specimens caught in subset of clusters by pyrethrum spray collection.
| Estimated Enrollment: | 28000 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Universal coverage of Long Lasting Insecticidal Nets (LLIN)
Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons
|
Device: Long Lasting Insecticidal Nets (LLIN)
Provision of LLIN to all community members in the clusters allocated to the study arm. LLIN protect individuals from bites by malaria vector mosquitoes by providing a physical barrier and insecticidal and repellent effect.
Other Names:
|
|
Experimental: LLIN Plus Indoor Residual Spraying
Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons plus indoor residual spraying with insecticide of interior walls of all houses twice yearly.
|
Other: Indoor residual insecticide spraying (IRS)
Application of insecticide to interior walls of domiciliary structures to kill malaria vector mosquitoes which rest on walls after taking human blood meal
Other Names:
Device: Long Lasting Insecticidal Nets (LLIN)
Provision of LLIN to all community members in the clusters allocated to the study arm. LLIN protect individuals from bites by malaria vector mosquitoes by providing a physical barrier and insecticidal and repellent effect.
Other Names:
|
Detailed Description:
The study will assess the impact that insecticide resistance has on the effectiveness of malaria vector control tools LLIN and IRS. This is done by a cluster randomised trials of universal coverage LLINs versus universal coverage LLINs in combination with IRS, with levels of baseline insecticide resistance in the main vector balanced between the two study arms. In each cluster resistance to the insecticide used on LLINs is monitored, and malaria incidence is estimated from cluster specific cohorts of children followed up over the duration of the study. Resistance impact will be assessed from the ratio of incidence rates in clusters with high compared to those with low resistance and from a continuous measure of resistance expressed as percentage loss of mosquito mortality when exposed to insecticide in standardised WHO tests. Resistance mechanisms will be studied in subsets of study clusters.
Eligibility| Ages Eligible for Study: | 6 Months to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Children older than 6 months and younger than 10 years in approximately 100 randomly selected households in all 140 study clusters selected in the four study areas
Exclusion Criteria:
- Children living in households within 1 km from the edge of a neighbouring cluster (the buffer zone)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713517
Contacts
| Contact: Hmooda T Kafy, MSc (London) | +249 123 399 994 | hmoodak@yahoo.com |
| Contact: Bashir A Ismail, MSc (USM) | +249 912938842 | bashiradam69@yahoo.co.uk |
Locations
| Sudan | |
| Malaria Control Programme | Recruiting |
| Gedarif, Gedarif State, Sudan | |
| Contact: Anwar Banaga, MSc +249 122645846 anwrbanaga@yahoo.com | |
| Malaria Control Programme | Recruiting |
| Wad Medani, Gezira State, Sudan | |
| Contact: Sakhr B Elshiekh, MSc +249 117587549 sakhr_14@yahoo.com | |
| Malaria Control Programme | Recruiting |
| Kassala, Kassala State, Sudan | |
| Contact: Shaaaldeen H Hussein, MSc +249 117587536 shaaaldeen64@gmail.com | |
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Federal Ministry of Health, Sudan
World Health Organization
Liverpool School of Tropical Medicine
Investigators
| Principal Investigator: | Immo Kleinschmidt, PhD | London School of Hygiene and Tropical Medicine |
| Principal Investigator: | Martin J Donnelly, PhD | Liverpool School of Tropical Medicine |
| Study Director: | Khalid A Elmardi, MD | Federal Ministry of Health, Sudan |
| Principal Investigator: | Hmooda T Kafy, MSc | Federal Ministry of Health, Sudan |
| Principal Investigator: | Bashir A Ismail, MSc | Federal Ministry of Health, Sudan |
| Principal Investigator: | Mohamed Ahmed A Mohamed, MSc | Federal Ministry of Health, Sudan |
More Information
No publications provided
| Responsible Party: | London School of Hygiene and Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT01713517 History of Changes |
| Other Study ID Numbers: | WHO_IR_SUDAN |
| Study First Received: | October 22, 2012 |
| Last Updated: | October 25, 2012 |
| Health Authority: | Sudan: Ministry of Health |
Keywords provided by London School of Hygiene and Tropical Medicine:
|
Mosquito Control Insecticide Resistance |
Additional relevant MeSH terms:
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013