MalariaPhase 4NCT01160809
Effect of a Combined Use of Mosquito Repellent and Insecticide Treated Net on Malaria in Ethiopia
A Phase 4 study testing Mosquito repellent in people with Malaria and Mosquito Repellent, run by Malaria Consortium, Ethiopia at 1 site in Ethiopia.
Trial summary
The combined use of a mosquito repellent and long lasting insecticidal nets (LLINs) by household members would result in a 40% reduction in malaria prevalence compared with households that only use LLINs. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria, Mosquito Repellent, Long Lasting Insecticidal Nets
- What is being tested?
- Mosquito repellent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,082 participants
- Where
- 1 siteEthiopia
- Study dates
- Sep 2008to Jan 2009
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All volunteer household members
Who cannot join
- Infants less than two months
- Not in the study area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Combined Use of Mosquito Repellent and Insecticide Treated Net on Malaria in Southern Ethiopia: a Cluster-randomized Controlled Trial
The combined use of a mosquito repellent and long lasting insecticidal nets (LLINs) by household members would result in a 40% reduction in malaria prevalence compared with households that only use LLINs.
Read the detailed description
It has been recognized that the use of malaria preventive measures in combination with LLINs could improve the effectiveness of nets in preventing the disease. This study examined the effect of a combined use of mosquito repellent (i.e., Buzz Off) and LLINs on malaria prevalence in an area of unstable and seasonal malaria transmission.
- Conditions
- Malaria, Mosquito Repellent, Long Lasting Insecticidal Nets
- Being tested
- Mosquito repellent
- Keywords
- Malaria, Mosquito repellent, LLINs
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mosquito repellentOther
Mosquito repellent (Buzz Off jelly) every evening applied to face, neck, hands and legs
| Study group | Role | What they receive |
|---|---|---|
| Mosquito repellent and LLINs group vs. LLINs group only | Experimental | This study is based on two population groups: 1) a group of households that use LLINs alone (control) and 2) a group of households that use both mosquito repellent and LLINs (repellent group). Receives: Other: Mosquito repellent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria parasite (P. falciparum and/or P. vivax)through microscopic detection
The objective of the study is to investigate the impact of a combined use of mosquito repellent and LLINs in reducing malaria. The primary outcome of the study is detection of malaria parasites (P. falciparum and/or P. vivax) through examination of microscopic blood slides collected from finger-pricks.
Secondary outcomes (1)
Household ownership and utilization of LLINs
Owneship and utilization of LLINs by household members during the night before the baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionJan 2009
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,082 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaria Consortium, Ethiopia
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Ababa University, Columbia University, Coalition Against Malaria in Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160809
- Sponsor's protocol ID
- 0001
- Status last verified
- Jul 2010
- First submitted
- 8 Jul 2010
- Last updated
- 12 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Deressa W, Yihdego YY, Kebede Z, Batisso E, Tekalegne A, Dagne GA. Effect of combining mosquito repellent and insecticide treated net on malaria prevalence in Southern Ethiopia: a cluster-randomised trial. Parasit Vectors. 2014 Mar 28;7:132. doi: 10.1186/1756-3305-7-132.
PubMed 24678612
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Combined Use of Mosquito Repellent and Insecticide Treated Net on Malaria in Southern Ethiopia: a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01160809
- Acronym / sponsor ID
- 0001
- Conditions
- Malaria, Mosquito Repellent, Long Lasting Insecticidal Nets
- Keywords
- Malaria, Mosquito repellent, LLINs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,082 participants (actual)
- Lead sponsor
- Malaria Consortium, EthiopiaUniversity, hospital or other
- Collaborators
- Addis Ababa University, Columbia University, Coalition Against Malaria in Ethiopia
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 12 Jul 2010 (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 combined use of a mosquito repellent and long lasting insecticidal nets (LLINs) by household members would result in a 40% reduction in malaria prevalence compared with households that only use LLINs.
Detailed description
It has been recognized that the use of malaria preventive measures in combination with LLINs could improve the effectiveness of nets in preventing the disease. This study examined the effect of a combined use of mosquito repellent (i.e., Buzz Off) and LLINs on malaria prevalence in an area of unstable and seasonal malaria transmission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mosquito repellent and LLINs group vs. LLINs group only | Experimental | Other: Mosquito repellentThis study is based on two population groups: 1) a group of households that use LLINs alone (control) and 2) a group of households that use both mosquito repellent and LLINs (repellent group). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All volunteer household members
Key exclusion criteria (2 listed)
- Infants less than two months
- Not in the study area
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 |
|---|---|---|
| Mosquito repellentMosquito repellent (Buzz Off jelly) every evening applied to face, neck, hands and legs | Other | Mosquito repellent and LLINs group vs. LLINs group only |
Primary outcome
Malaria parasite (P. falciparum and/or P. vivax)through microscopic detection
The objective of the study is to investigate the impact of a combined use of mosquito repellent and LLINs in reducing malaria. The primary outcome of the study is detection of malaria parasites (P. falciparum and/or P. vivax) through examination of microscopic blood slides collected from finger-pricks.
1 secondary outcome
Household ownership and utilization of LLINs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2010.
- Derived from this study: PubMed 24678612Deressa W, Yihdego YY, Kebede Z, Batisso E, Tekalegne A, Dagne GA. Effect of combining mosquito repellent and insecticide treated net on malaria prevalence in Southern Ethiopia: a cluster-randomised trial. Parasit Vectors. 2014 Mar 28;7:132. doi: 10.1186/1756-3305-7-132.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mosquito repellent in people with Malaria and Mosquito Repellent, run by Malaria Consortium, Ethiopia at 1 site in Ethiopia.
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 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: finished, as of the sponsor's last update on 12 Jul 2010. 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 Ethiopia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malaria parasite (P. falciparum and/or P. vivax)through microscopic detection. 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 NCT01160809, 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 12 Jul 2010.