Insecticide ResistancePhase 4Net-PBONCT03289663
Effectiveness Study of New Generation Bednets in the Context of Conventional Insecticide Resistance in the Democratic Republic of the Congo
A Phase 4 study testing synergistic combination of insecticides and Pyrethroids in people with Insecticide Resistance, run by Université de Lubumbashi at 1 site in Democratic Republic of the Congo.
Trial summary
Despite the mass distribution of LLINs (long-lasting insecticidal nets) as a Malaria control strategy, populations are still continuously exposed to a high frequency of malarial inoculation in some countries. The situation can be explained by a swift increase in the resistance of Anopheles to common insecticides. Read more about this study
- Who is it for?
- Ages Up to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Insecticide Resistance
- What is being tested?
- synergistic combination of insecticides and Pyrethroids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,680 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 2 Oct 2017to Sep 2019
- 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 Up to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- refusal of the head of household to participate
- known allergy to insecticides
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Hôpital Général de Référence Saint Luc
Kisantu, Bas-Congo Province
About this study
Official title: Effectiveness Study of Bednets Treated With Synegistic Combination of Insectcides in an Area With Pyrethroid-resistant Vectors in the Democratic Republic of the Congo
Despite the mass distribution of LLINs (long-lasting insecticidal nets) as a Malaria control strategy, populations are still continuously exposed to a high frequency of malarial inoculation in some countries. The situation can be explained by a swift increase in the resistance of Anopheles to common insecticides. To preserve the gains of insecticides and improve their effectiveness, a new generation of bednets treated with piperonyl butoxide combination insectides have emerged.But more evidence is needed to plead for scale up of their usage. The lack of information relating to the additional impact of that combination on the transmission of Malaria, its relative efficacy in real-life setting and its safety in users are the rationale for more investigation.This will be a randomized controlled study on a dynamic cohort of households with 1680, 0-10 years-old subjects in 30 villages will be recruited to compute the effectiveness of this new tool.
The findings will be useful information for decision-making by national malaria control programs, their partners, the international community and the bednet manufacturers with regard to the effectiveness of the new combination of insecticides in real-life context. The results will also enable a better design of the tool in the future and a broader understanding of long-term dynamics for sustainability, as well as identification of some factors with negative impacts on the benefits of the strategy.
- Conditions
- Insecticide Resistance
- Being tested
- synergistic combination of insecticides, Pyrethroids
- Keywords
- synergistic combination, insecticide resistance, vectors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synergistic combination of insecticidesDrug
third generation insecticide -treated bednets
PyrethroidsDrug
Conventional insecticide
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The arm will receive bednets treated with conventional insecticide (Pyrethroid) Receives: Drug: Pyrethroids |
| Experimental | Experimental | The arm will receive bednets treated with new generation of insecticides (synergistic combination of insecticides) Receives: Drug: synergistic combination of insecticides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of laboratory confirmed clinical cases of Malaria
Microscopy to confirm the diagnosis of Malaria
Measured: Participants will be actively followed up for 12 months. And any suspected case of clinical Malaria will immediately lead to microscopy and RDT for confirmation
Sporozoite rate
Sporozoite detection by ELISA to determine infectivity of anopheles
Measured: Anopheles mosquitoes will be captured every 3 months during 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start2 Oct 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (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 Insecticide ResistanceStudies 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
- Model description
- Cluster-randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Lubumbashi
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Gillon Ilombe Kaounga, Ministry of Public Health, Democratic Republic of the Congo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289663
- Sponsor's protocol ID
- NET-06-08-76
- Acronym
- Net-PBO
- Status last verified
- Apr 2018
- First submitted
- 10 Aug 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gleave K, Lissenden N, Chaplin M, Choi L, Ranson H. Piperonyl butoxide (PBO) combined with pyrethroids in insecticide-treated nets to prevent malaria in Africa. Cochrane Database Syst Rev. 2021 May 24;5(5):CD012776. doi: 10.1002/14651858.CD012776.pub3.
PubMed 34027998
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Study of Bednets Treated With Synegistic Combination of Insectcides in an Area With Pyrethroid-resistant Vectors in the Democratic Republic of the Congo
- ClinicalTrials.gov ID
- NCT03289663
- Acronym / sponsor ID
- Net-PBO / NET-06-08-76
- Conditions
- Insecticide Resistance
- Keywords
- synergistic combination, insecticide resistance, vectors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,680 participants (estimated)
- Lead sponsor
- Université de LubumbashiUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, Centers for Disease Control and Prevention
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 21 Sep 2017 (actual)
- 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.
Despite the mass distribution of LLINs (long-lasting insecticidal nets) as a Malaria control strategy, populations are still continuously exposed to a high frequency of malarial inoculation in some countries. The situation can be explained by a swift increase in the resistance of Anopheles to common insecticides. To preserve the gains of insecticides and improve their effectiveness, a new generation of bednets treated with piperonyl butoxide combination insectides have emerged.But more evidence is needed to plead for scale up of their usage. The lack of information relating to the additional impact of that combination on the transmission of Malaria, its relative efficacy in real-life setting and its safety in users are the rationale for more investigation.This will be a randomized controlled study on a dynamic cohort of households with 1680, 0-10 years-old subjects in 30 villages will be recruited to compute the effectiveness of this new tool.
The findings will be useful information for decision-making by national malaria control programs, their partners, the international community and the bednet manufacturers with regard to the effectiveness of the new combination of insecticides in real-life context. The results will also enable a better design of the tool in the future and a broader understanding of long-term dynamics for sustainability, as well as identification of some factors with negative impacts on the benefits of the strategy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: PyrethroidsThe arm will receive bednets treated with conventional insecticide (Pyrethroid) |
| Experimental | Experimental | Drug: synergistic combination of insecticidesThe arm will receive bednets treated with new generation of insecticides (synergistic combination of insecticides) |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- refusal of the head of household to participate
- known allergy to insecticides
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 |
|---|---|---|
| synergistic combination of insecticidesthird generation insecticide -treated bednets | Drug | Experimental |
| PyrethroidsConventional insecticide | Drug | Control |
Primary outcome
Incidence rate of laboratory confirmed clinical cases of Malaria
Time frame: Participants will be actively followed up for 12 months. And any suspected case of clinical Malaria will immediately lead to microscopy and RDT for confirmation
Microscopy to confirm the diagnosis of Malaria
Sporozoite rate
Time frame: Anopheles mosquitoes will be captured every 3 months during 1 year
Sporozoite detection by ELISA to determine infectivity of anopheles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Derived from this study: PubMed 34027998Gleave K, Lissenden N, Chaplin M, Choi L, Ranson H. Piperonyl butoxide (PBO) combined with pyrethroids in insecticide-treated nets to prevent malaria in Africa. Cochrane Database Syst Rev. 2021 May 24;5(5):CD012776. doi: 10.1002/14651858.CD012776.pub3.
- Individual participant dataSharing planned: Undecided
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 synergistic combination of insecticides and Pyrethroids in people with Insecticide Resistance, run by Université de Lubumbashi at 1 site in Democratic Republic of the Congo.
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 0 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 11 Apr 2018. 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 Democratic Republic of the Congo. 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?
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?
Incidence rate of laboratory confirmed clinical cases of Malaria (time frame: Participants will be actively followed up for 12 months. And any suspected case of clinical Malaria will immediately lead to microscopy and RDT for confirmation). The study lists 2 primary outcomes in all. 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 NCT03289663, 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 11 Apr 2018.