MalariaPhase 4NCT01697852
The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention
A Phase 4 study testing Indoor residual spraying with bendiocarb and LLIN by universal coverage campaign in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
Trial summary
The study is a cluster randomised trial to compare the effectiveness of indoor residual spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the effectiveness of LLINs alone for preventing malaria infection and morbidity. Read more about this study
- Who is it for?
- Ages 6 months to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Indoor residual spraying with bendiocarb and LLIN by universal coverage campaign
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,300 participants
- Where
- 1 siteTanzania
- Study dates
- Jan 2011to Dec 2012
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- resident in selected cluster (village)
Who cannot join
- Not resident in selected cluster (village)
Trial locations and contacts
1 site in 1 country.
Mark Rowland, PHD contact
Immo Kleinschmidt, PHD contact
Tanzania1 site, 1 recruiting
- Recruiting
PAMVERC office
Muleba, Kagera
Natacha Protopopoff, PHD, nprotopopoff@gmail.com
Natacha Protopopoff, PHD
About this study
Official title: Cluster Randomised Trial to Compare Effectiveness of the Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) to LLINs Alone for Malaria Prevention in Muleba District, Kagera Region, Tanzania
The study is a cluster randomised trial to compare the effectiveness of indoor residual spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years, measured in cross sectional surveys. Secondary outcomes include relative population density for each mosquito vector species, malaria transmission as measured by entomological inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers including kdr, and user acceptability of LLINs compared with IRS.
Findings from this study are expected to inform decision making so that resource utilization can be optimised.
- Conditions
- Malaria
- Being tested
- Indoor residual spraying with bendiocarb, LLIN by universal coverage campaign
- Keywords
- vector control, LLIN, IRS
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indoor residual spraying with bendiocarbOther
Also called Ficam
2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart
LLIN by universal coverage campaignOther
Also called Olyset nets
Long lasting Insecticide treated mosquito net
| Study group | Role | What they receive |
|---|---|---|
| LLIN plus IRS | Experimental | LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide Receives: Other: Indoor residual spraying with bendiocarb; Other: LLIN by universal coverage campaign |
| LLIN only | Active comparator | LLIN by universal coverage campaign Receives: Other: LLIN by universal coverage campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of malarial infection in children 6 months to 10 years
Measured: 9 months post randomisation
Secondary outcomes (2)
Moderate to severe anaemia in children under 5 years
Measured: 9 months post randomisation
Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years
Measured: 6 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startJan 2011
- Primary completionNov 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies 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
- 22,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Kilimanjaro Christian Medical Centre, Tanzania
- Responsible party
- Sponsor
- Investigators
- Mark Rowland, PHD, Principal investigator, London School of Hygiene and Tropical MedicineImmo Kleinschmidt, PHD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697852
- Sponsor's protocol ID
- ITDCVP54
- Status last verified
- Oct 2012
- First submitted
- 21 Sep 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kleinschmidt I, Schwabe C, Shiva M, Segura JL, Sima V, Mabunda SJ, Coleman M. Combining indoor residual spraying and insecticide-treated net interventions. Am J Trop Med Hyg. 2009 Sep;81(3):519-24.
PubMed 19706925West PA, Protopopoff N, Rowland MW, Kirby MJ, Oxborough RM, Mosha FW, Malima R, Kleinschmidt I. Evaluation of a national universal coverage campaign of long-lasting insecticidal nets in a rural district in north-west Tanzania. Malar J. 2012 Aug 10;11:273. doi: 10.1186/1475-2875-11-273.
PubMed 22882836West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Enhanced protection against malaria by indoor residual spraying in addition to insecticide treated nets: is it dependent on transmission intensity or net usage? PLoS One. 2015 Mar 26;10(3):e0115661. doi: 10.1371/journal.pone.0115661. eCollection 2015.
PubMed 25811379West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Indoor residual spraying in combination with insecticide-treated nets compared to insecticide-treated nets alone for protection against malaria: a cluster randomised trial in Tanzania. PLoS Med. 2014 Apr 15;11(4):e1001630. doi: 10.1371/journal.pmed.1001630. eCollection 2014 Apr.
PubMed 24736370
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomised Trial to Compare Effectiveness of the Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) to LLINs Alone for Malaria Prevention in Muleba District, Kagera Region, Tanzania
- ClinicalTrials.gov ID
- NCT01697852
- Acronym / sponsor ID
- ITDCVP54
- Conditions
- Malaria
- Keywords
- vector control, LLIN, IRS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22,300 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Kilimanjaro Christian Medical Centre, Tanzania
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 2 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 study is a cluster randomised trial to compare the effectiveness of indoor residual spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years, measured in cross sectional surveys. Secondary outcomes include relative population density for each mosquito vector species, malaria transmission as measured by entomological inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers including kdr, and user acceptability of LLINs compared with IRS.
Findings from this study are expected to inform decision making so that resource utilization can be optimised.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLIN plus IRS | Experimental | Other: Indoor residual spraying with bendiocarb, Other: LLIN by universal coverage campaignLLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide |
| LLIN only | Active comparator | Other: LLIN by universal coverage campaignLLIN by universal coverage campaign |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- resident in selected cluster (village)
Key exclusion criteria (1 listed)
- Not resident in selected cluster (village)
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 spraying with bendiocarbAlso: Ficam2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart | Other | LLIN plus IRS |
| LLIN by universal coverage campaignAlso: Olyset netsLong lasting Insecticide treated mosquito net | Other | LLIN only, LLIN plus IRS |
Primary outcome
Prevalence of malarial infection in children 6 months to 10 years
Time frame: 9 months post randomisation
2 secondary outcomes
Moderate to severe anaemia in children under 5 years
Time frame: 9 months post randomisation
Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years
Time frame: 6 months post randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
- Background: PubMed 19706925Kleinschmidt I, Schwabe C, Shiva M, Segura JL, Sima V, Mabunda SJ, Coleman M. Combining indoor residual spraying and insecticide-treated net interventions. Am J Trop Med Hyg. 2009 Sep;81(3):519-24.
- Results publication: PubMed 22882836West PA, Protopopoff N, Rowland MW, Kirby MJ, Oxborough RM, Mosha FW, Malima R, Kleinschmidt I. Evaluation of a national universal coverage campaign of long-lasting insecticidal nets in a rural district in north-west Tanzania. Malar J. 2012 Aug 10;11:273. doi: 10.1186/1475-2875-11-273.
- Derived from this study: PubMed 25811379West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Enhanced protection against malaria by indoor residual spraying in addition to insecticide treated nets: is it dependent on transmission intensity or net usage? PLoS One. 2015 Mar 26;10(3):e0115661. doi: 10.1371/journal.pone.0115661. eCollection 2015.
- Derived from this study: PubMed 24736370West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Indoor residual spraying in combination with insecticide-treated nets compared to insecticide-treated nets alone for protection against malaria: a cluster randomised trial in Tanzania. PLoS Med. 2014 Apr 15;11(4):e1001630. doi: 10.1371/journal.pmed.1001630. eCollection 2014 Apr.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
Mark Rowland, PHD contact
Immo Kleinschmidt, PHD contact
Mark Rowland, PHD principal investigator
London School of Hygiene and Tropical Medicine
Immo Kleinschmidt, PHD principal investigator
London School of Hygiene and Tropical Medicine
1 site 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 spraying with bendiocarb and LLIN by universal coverage campaign in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
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 3 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 1 site in Tanzania. 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 Mark Rowland, PHD (Mark.Rowland@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of malarial infection in children 6 months to 10 years (time frame: 9 months post randomisation). 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 NCT01697852, which also lists 4 linked publications.
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 3 Oct 2012.