Clinical trial NCT03289663: Effectiveness Study of New Generation Bednets in the Context of Conventional Insecticide Resistance in the Democratic Republic of the Congo
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Insecticide Resistance
Keywords: synergistic combination
insecticide resistance
vectors
Lead sponsor: Université de Lubumbashi
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: Centers for Disease Control and Prevention
First posted: 2017-09-21
Enrollment: 1680
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized trial
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria : -households where there are one or more children below the age of 10 years;

* Ability and willingness of the head of the household to participate based on signed informed consent (or fingerprint) and with the assistance of an impartial witness (if the head of the household is illiterate)

Exclusion Criteria :

* refusal of the head of household to participate
* known allergy to insecticides

Primary outcomes:
measure: Incidence rate of laboratory confirmed clinical cases of Malaria
timeFrame: 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
measure: Sporozoite rate
timeFrame: Anopheles mosquitoes will be captured every 3 months during 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kisantu
country: Congo, The Democratic Republic of the
facility: Hôpital Général de Référence Saint Luc
state: Kongo-Central
Study officials:
References:
citation: 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.