Malaria, FalciparumPhase 4NCT01713517
Impact of Insecticide Resistance on Vector Control
A Phase 4 study testing Indoor residual insecticide spraying (IRS) and Long Lasting Insecticidal Nets (LLIN) in people with Malaria, Falciparum, run by London School of Hygiene and Tropical Medicine at 3 sites in Sudan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Indoor residual insecticide spraying (IRS) and Long Lasting Insecticidal Nets (LLIN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28,000 participants
- Where
- 3 sitesSudan
- Study dates
- Apr 2011to Oct 2014
- Phase
- Phase 4
- 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 6 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children living in households within 1 km from the edge of a neighbouring cluster (the buffer zone)
Trial locations and contacts
3 sites in 1 country.
Sudan3 sites, 3 recruiting
- Recruiting
Malaria Control Programme
Gedarif, Gedarif State
Anwar Banaga, MSc, +249 122645846, anwrbanaga@yahoo.com
- Recruiting
Malaria Control Programme
Kassala, Kassala
Shaaaldeen H Hussein, MSc, +249 117587536, shaaaldeen64@gmail.com
- Recruiting
Malaria Control Programme
Wad Medani, Al Jazirah
Sakhr B Elshiekh, MSc, +249 117587549, sakhr_14@yahoo.com
About this study
Official title: Impact of Insecticide Resistance in Anopheles Arabiensis on the Effectiveness of Malaria Vector Control in Sudan
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.
Read the 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.
- Conditions
- Malaria, Falciparum
- Being tested
- Indoor residual insecticide spraying (IRS), Long Lasting Insecticidal Nets (LLIN)
- Keywords
- Mosquito Control, Insecticide Resistance
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indoor residual insecticide spraying (IRS)Other
Also called IRS, Pesticide, Bendiocarb, Deltamethrin
Application of insecticide to interior walls of domiciliary structures to kill malaria vector mosquitoes which rest on walls after taking human blood meal
Long Lasting Insecticidal Nets (LLIN)Device
Also called Insecticide Treated Nets (ITN), Permanet2.0
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.
| Study group | Role | What they receive |
|---|---|---|
| Universal coverage of Long Lasting Insecticidal Nets (LLIN) | Active comparator | Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons Receives: Device: Long Lasting Insecticidal Nets (LLIN) |
| LLIN Plus Indoor Residual Spraying | Experimental | 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. Receives: Other: Indoor residual insecticide spraying (IRS); Device: Long Lasting Insecticidal Nets (LLIN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria Incidence
Infection with malarial parasites determined by rapid diagnostic tests/microscopy in cohort members who report or have fever (>37.5C)
Measured: 3 years
Secondary outcomes (3)
Prevalence of P.falciparum Infection
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
Measured: 3 years
Entomological Innoculation rate
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.
Measured: Average for months Sept, Oct, Nov for years 2011, 2012, 2013
Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis
Molecular analysis of mosquito specimens caught in subset of clusters by pyrethrum spray collection.
Measured: Yearly average 2011, 2012, 2013, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startApr 2011
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
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 Malaria, FalciparumStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Health, Sudan, World Health Organization, Liverpool School of Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Immo Kleinschmidt, PhD, Principal investigator, London School of Hygiene and Tropical MedicineMartin J Donnelly, PhD, Principal investigator, Liverpool School of Tropical MedicineKhalid A Elmardi, MD, Study director, Federal Ministry of Health, SudanHmooda T Kafy, MSc, Principal investigator, Federal Ministry of Health, SudanBashir A Ismail, MSc, Principal investigator, Federal Ministry of Health, SudanMohamed Ahmed A Mohamed, MSc, Principal investigator, Federal Ministry of Health, Sudan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713517
- Sponsor's protocol ID
- WHO_IR_SUDAN
- Status last verified
- Oct 2012
- First submitted
- 22 Oct 2012
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kafy HT, Ismail BA, Mnzava AP, Lines J, Abdin MSE, Eltaher JS, Banaga AO, West P, Bradley J, Cook J, Thomas B, Subramaniam K, Hemingway J, Knox TB, Malik EM, Yukich JO, Donnelly MJ, Kleinschmidt I. Impact of insecticide resistance in Anopheles arabiensis on malaria incidence and prevalence in Sudan and the costs of mitigation. Proc Natl Acad Sci U S A. 2017 Dec 26;114(52):E11267-E11275. doi: 10.1073/pnas.1713814114. Epub 2017 Dec 11.
PubMed 29229808
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Insecticide Resistance in Anopheles Arabiensis on the Effectiveness of Malaria Vector Control in Sudan
- ClinicalTrials.gov ID
- NCT01713517
- Acronym / sponsor ID
- WHO_IR_SUDAN
- Conditions
- Malaria, Falciparum
- Keywords
- Mosquito Control, Insecticide Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Federal Ministry of Health, Sudan, World Health Organization, Liverpool School of Tropical Medicine
- Study start
- Apr 2011
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 24 Oct 2012 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Universal coverage of Long Lasting Insecticidal Nets (LLIN) | Active comparator | Device: 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 |
| LLIN Plus Indoor Residual Spraying | Experimental | Other: Indoor residual insecticide spraying (IRS), Device: 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 plus indoor residual spraying with insecticide of interior walls of all houses twice yearly. |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Children living in households within 1 km from the edge of a neighbouring cluster (the buffer zone)
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 |
|---|---|---|
| Indoor residual insecticide spraying (IRS)Also: IRS, Pesticide, Bendiocarb, DeltamethrinApplication of insecticide to interior walls of domiciliary structures to kill malaria vector mosquitoes which rest on walls after taking human blood meal | Other | LLIN Plus Indoor Residual Spraying |
| Long Lasting Insecticidal Nets (LLIN)Also: Insecticide Treated Nets (ITN), Permanet2.0Provision 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. | Device | LLIN Plus Indoor Residual Spraying, Universal coverage of Long Lasting Insecticidal Nets (LLIN) |
Primary outcome
Malaria Incidence
Time frame: 3 years
Infection with malarial parasites determined by rapid diagnostic tests/microscopy in cohort members who report or have fever (>37.5C)
3 secondary outcomes
Prevalence of P.falciparum Infection
Time frame: 3 years
Entomological Innoculation rate
Time frame: Average for months Sept, Oct, Nov for years 2011, 2012, 2013
Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis
Time frame: Yearly average 2011, 2012, 2013, 2014
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
- Derived from this study: PubMed 29229808Kafy HT, Ismail BA, Mnzava AP, Lines J, Abdin MSE, Eltaher JS, Banaga AO, West P, Bradley J, Cook J, Thomas B, Subramaniam K, Hemingway J, Knox TB, Malik EM, Yukich JO, Donnelly MJ, Kleinschmidt I. Impact of insecticide resistance in Anopheles arabiensis on malaria incidence and prevalence in Sudan and the costs of mitigation. Proc Natl Acad Sci U S A. 2017 Dec 26;114(52):E11267-E11275. doi: 10.1073/pnas.1713814114. Epub 2017 Dec 11.
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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.
Immo Kleinschmidt, PhD principal investigator
London School of Hygiene and Tropical Medicine
Martin J Donnelly, PhD principal investigator
Liverpool School of Tropical Medicine
Khalid A Elmardi, MD study director
Federal Ministry of Health, Sudan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indoor residual insecticide spraying (IRS) and Long Lasting Insecticidal Nets (LLIN) in people with Malaria, Falciparum, run by London School of Hygiene and Tropical Medicine at 3 sites in Sudan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sudan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hmooda T Kafy, MSc (London) (+249 123 399 994, hmoodak@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malaria Incidence (time frame: 3 years). 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 NCT01713517, 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 26 Oct 2012.