MalariaPhase 3NCT00938379
Clinical Evaluation of Insect Repellent and Insecticide Treated Nets in Lao PDR
A Phase 3 study testing 20% deet insect repellent in people with Malaria and Dengue, run by London School of Hygiene and Tropical Medicine at 1 site in Laos.
Trial summary
Rural communities involved in agriculture are often at highest risk of insect-borne diseases in Southeast (SE) Asia. Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas. Read more about this study
- Who is it for?
- Ages 5 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Dengue, Japanese Encephalitis
- What is being tested?
- 20% deet insect repellent
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,000 participants
- Where
- 1 siteLaos
- Study dates
- Jul 2009to Jun 2011
- Phase
- Phase 3
- 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 5 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- working in agriculture
- available for monthly follow-up
Who cannot join
- allergy to repellent
- pregnant / breastfeeding
Trial locations and contacts
1 site in 1 country.
Vanessa Chen-Hussey, MSc contact
Laos1 site, 1 recruiting
- Recruiting
Rural villages in Attepu and Sekong Provinces, Laos PDR
Pakse, Attepu
Vanessa Chen-Hussey, MSc, 856 (0)21 353 408 ext. 116, vanessa.chen-hussey@lshtm.ac.uk
Vanessa Chen-Hussey, MSc
About this study
Official title: Clinical Evaluation of Insect Repellent and Insecticide Treated Nets Against Malaria, JE & Dengue in Rural Communities in Lao PDR
Rural communities involved in agriculture are often at highest risk of insect-borne diseases in Southeast (SE) Asia.
Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas.
This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to 1000 households from 100 villages in rural Laos. In each house the investigators shall recruit up to 5 individuals. Half of households will be randomised to repellent, half to a placebo. All individuals will be provided with insecticide treated bed nets for use at night. All household occupants will be followed for 7 months to record malaria cases by Rapid Diagnostic Test every month. Blood spots will be collected at start and end of study to measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated. Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese Encephalitis (secondary outcomes).
- Conditions
- Malaria, Dengue, Japanese Encephalitis
- Being tested
- 20% deet insect repellent, placebo control
- Keywords
- mosquito, repellent, vector control, malaria
- Medical subject headings
- Malaria, Dengue, Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% deet insect repellentDrug
skin-applied repellent lotion
placebo controlDrug
Identical base formulation of lotion but without any deet active
| Study group | Role | What they receive |
|---|---|---|
| 20% deet insect repellent | Experimental | experimental intervention Receives: Drug: 20% deet insect repellent |
| lotion without repellent active | Placebo comparator | Not described Receives: Drug: placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in malaria incidence
Measured: monthly over 7 months
Secondary outcomes (1)
Reduction in Japanese Encephalitis and / or Dengue infections
Measured: After 7 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (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 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Population Services International
- Investigators
- Nigel Hill, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938379
- Sponsor's protocol ID
- NHLAO1
- Status last verified
- Jul 2009
- First submitted
- 10 Jul 2009
- Last updated
- 14 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen-Hussey V, Carneiro I, Keomanila H, Gray R, Bannavong S, Phanalasy S, Lindsay SW. Can topical insect repellents reduce malaria? A cluster-randomised controlled trial of the insect repellent N,N-diethyl-m-toluamide (DEET) in Lao PDR. PLoS One. 2013 Aug 14;8(8):e70664. doi: 10.1371/journal.pone.0070664. eCollection 2013.
PubMed 23967083
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Insect Repellent and Insecticide Treated Nets Against Malaria, JE & Dengue in Rural Communities in Lao PDR
- ClinicalTrials.gov ID
- NCT00938379
- Acronym / sponsor ID
- NHLAO1
- Conditions
- Malaria, Dengue, Japanese Encephalitis
- Keywords
- mosquito, repellent, vector control, malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Population Services International
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 13 Jul 2009 (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.
Rural communities involved in agriculture are often at highest risk of insect-borne diseases in Southeast (SE) Asia.
Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas.
This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to 1000 households from 100 villages in rural Laos. In each house the investigators shall recruit up to 5 individuals. Half of households will be randomised to repellent, half to a placebo. All individuals will be provided with insecticide treated bed nets for use at night. All household occupants will be followed for 7 months to record malaria cases by Rapid Diagnostic Test every month. Blood spots will be collected at start and end of study to measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated. Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese Encephalitis (secondary outcomes).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20% deet insect repellent | Experimental | Drug: 20% deet insect repellentexperimental intervention |
| lotion without repellent active | Placebo comparator | Drug: placebo control |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- working in agriculture
- available for monthly follow-up
Key exclusion criteria (2 listed)
- allergy to repellent
- pregnant / breastfeeding
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 |
|---|---|---|
| 20% deet insect repellentskin-applied repellent lotion | Drug | 20% deet insect repellent |
| placebo controlIdentical base formulation of lotion but without any deet active | Drug | lotion without repellent active |
Primary outcome
reduction in malaria incidence
Time frame: monthly over 7 months
1 secondary outcome
Reduction in Japanese Encephalitis and / or Dengue infections
Time frame: After 7 months intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2009.
- Derived from this study: PubMed 23967083Chen-Hussey V, Carneiro I, Keomanila H, Gray R, Bannavong S, Phanalasy S, Lindsay SW. Can topical insect repellents reduce malaria? A cluster-randomised controlled trial of the insect repellent N,N-diethyl-m-toluamide (DEET) in Lao PDR. PLoS One. 2013 Aug 14;8(8):e70664. doi: 10.1371/journal.pone.0070664. eCollection 2013.
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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.
Vanessa Chen-Hussey, MSc contact
Nigel Hill, 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 3 study testing 20% deet insect repellent in people with Malaria and Dengue, run by London School of Hygiene and Tropical Medicine at 1 site in Laos.
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 2 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 14 Jul 2009. 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 Laos. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Vanessa Chen-Hussey, MSc (vanessa.chen-hussey@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in malaria incidence (time frame: monthly over 7 months). 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 NCT00938379, 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 14 Jul 2009.